<ichicsr lang="en">
  <ichicsrmessageheader>
    <messagetype>ICSR</messagetype>
    <messageformatversion>2.1</messageformatversion>
    <messageformatrelease>1.0</messageformatrelease>
    <messagenumb>2004-12</messagenumb>
    <messagesenderidentifier>FDA CDER ODS</messagesenderidentifier>
    <messagereceiveridentifier>Public Use</messagereceiveridentifier>
    <messagedateformat>204</messagedateformat>
    <messagedate>2005032806:04:30</messagedate>
  </ichicsrmessageheader>
  <safetyreport>
    <safetyreportid>4514736-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20041104723</companynumb>
    <primarysource>
      <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>ENDOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LISTERIOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514737-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041105090</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>4RMKA703;04B011</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL-D3</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL-D3</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514738-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105171</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROSPINAL FLUID LEAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMENINGOCELE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514739-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105183</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>144.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <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>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514740-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105185</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLONOSCOPY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX GASTRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514741-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105187</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.07</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTAZIDE</medicinalproduct>
        <drugdosagetext>25/25 DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514742-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105195</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514743-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105210</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</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>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514744-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105211</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514745-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105212</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514746-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105213</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTOPLASMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>04F061P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>04F061P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURINETHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B-12</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514747-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105314</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SICK SINUS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>160/12.5 TWICE DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>100/12.5 TWICE DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOPTIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514748-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105322</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.12</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</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>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20/25 DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>1-3 MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514749-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105325</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX 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>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM +D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514750-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105328</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.03</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOSARCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514751-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-JNJFOC-20041105340</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CACHEXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CACHEXIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514752-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105411</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDO LYMPHOMA</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>AMBIEN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugdosagetext>2 PUFFS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTRISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTRISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514753-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105415</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.11</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY COMMON VARIABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</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>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVOXAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugdosagetext>1 TBSP</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514754-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105635</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514755-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105636</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>39.46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELAFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
        <drugdosagetext>1 DROP TO EACH EYE DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514756-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105637</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</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>HUMIRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514757-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105723</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514758-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105749</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>36.29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>LAST OF SIX INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514759-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20041106105</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OBLITERATIVE BRONCHIOLITIS</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>CORTICOIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENOTONIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514760-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20041106107</companynumb>
    <primarysource>
      <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>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</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>CORTICOIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514761-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040805315</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>ONCE OR TWICE DAILY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLORIDE</medicinalproduct>
        <drugdosagetext>4 OR 5 YEARS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORAL CALCIUM</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514762-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040808916</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>39.01</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</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>ENALAPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514763-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040803094</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514764-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041003599</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.39</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IRIS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEXPECTED THERAPEUTIC DRUG EFFECT</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>HAD 3 TREATMENTS IN ? 1998</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514765-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040909181</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514766-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040701811</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</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>INTIATED IN INFLIXIMAB THERAPY ^4 YEARS AGO^</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>NITRO QUICK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORFINE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORCET-HD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LONOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LONOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514768-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105583</companynumb>
    <primarysource>
      <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>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514769-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105186</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <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>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDRONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514781-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20040907667</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GUILLAIN-BARRE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROID INHALER</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514811-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004GR15751</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>1800 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>1500 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514814-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-164-0274439-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47.216</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>100579A40</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
        <drugtreatmentduration>83</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</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>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</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>EPOGEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</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>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514816-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0281426-00</companynumb>
    <primarysource></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>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAXTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514817-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0281274-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</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>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514832-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200417620US</companynumb>
    <primarysource>
      <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>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041003</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514835-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200418120US</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>123.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYASTHENIA GRAVIS CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASMAPHERESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>1075816</drugbatchnumb>
        <drugdosagetext>DOSE: 800 (X 5 DAYS)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>1075816</drugbatchnumb>
        <drugdosagetext>DOSE: 800 (X 5 DAYS)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS BACTERIAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESTINON</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 37.5/25</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514837-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413431JP</companynumb>
    <primarysource>
      <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>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>RHINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITH</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514843-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-BRISTOL-MYERS SQUIBB COMPANY-12771010</companynumb>
    <primarysource>
      <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>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTREXYL</medicinalproduct>
        <drugindication>PNEUMONIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTREXYL</medicinalproduct>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
        <drugindication>PULMONARY EMBOLISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAFORAN</medicinalproduct>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAFORAN</medicinalproduct>
        <drugindication>PNEUMONIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514844-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-12771580</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYSEPTONE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLOXENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLIMARA</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDOMIGRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEXITIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURALEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514845-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12775649</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GATIFLO TABS 100 MG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALONAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514846-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-12776860</companynumb>
    <primarysource>
      <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>PORTAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPINAVIR + RITONAVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514847-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-12764825</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS RADIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>07-OCT-04, THERAPY INIT. REC'D 5 CYCLES. WITHHELD DUE TO ADMISSION. RESTARTED ON 19-NOV-04.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514849-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12768032</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRAMIL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMIQUE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>AGITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugindication>AGITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRESUBIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514852-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-240253</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENERGY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXERCISE CAPACITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVIGILANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULATARD FLEXPEN</medicinalproduct>
        <drugdosagetext>19 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULATARD FLEXPEN</medicinalproduct>
        <drugdosagetext>18 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID FLEXPEN</medicinalproduct>
        <drugdosagetext>15 IU, UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR FLEXPEN</medicinalproduct>
        <drugdosagetext>19 IU, QD</drugdosagetext>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE</medicinalproduct>
        <drugdosagetext>12 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOMIX 30 PENFILL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514865-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030729</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NSADSS2001002455</companynumb>
    <primarysource>
      <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 DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPULSID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514866-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105442</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>24.95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRUXISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514867-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041002557</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.37</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugdosagetext>15 MG DAILY PLUS 30 MG EVERY NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514868-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105741</companynumb>
    <primarysource>
      <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>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514869-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041106180</companynumb>
    <primarysource>
      <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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEEDING TUBE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>ONE TABLET NIGHTLY, VIA G-TUBE</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALAGEN</medicinalproduct>
        <drugdosagetext>2 DAILY, VIA G-TUBE</drugdosagetext>
        <drugindication>DRY MOUTH</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514870-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20041106196</companynumb>
    <primarysource>
      <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>DURAGESIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514871-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041106415</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514872-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041103698</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.79</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0327294</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE</medicinalproduct>
        <drugdosagetext>SIX 2 MG TABLETS IN LESS THAN 24 HOURS</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANNABIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514873-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041104737</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>44.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>5 - 10 MG, 4 TIMES DAILY</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514874-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20041003607</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGLE CLOSURE GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugdosagetext>(FOR MANY YEARS) TAKES EIGHT 250 MG TABLETS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514875-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105823</companynumb>
    <primarysource>
      <qualification>5</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514876-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041106100</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPROLACTINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SETRALINE</medicinalproduct>
        <drugdosagetext>175-75MG</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1-4 MG PRN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYTETRACYCLINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514886-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03416</companynumb>
    <primarysource>
      <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>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514887-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03419</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514892-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CA15770</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>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514920-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SOLVAY-00304004128</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>688</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TESTOGEL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BLOOD TESTOSTERONE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOPTIC</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514924-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0281166-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE EXACERBATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514925-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-12733861</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDREA</medicinalproduct>
        <drugdosagetext>500 MG DAILY COMMENCED IN MAY 2000. ^5 GRAM TO 20 GRAM^ ADMINISTERED ON 17-OCT-2004</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL THROMBOCYTHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514926-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-04P-062-0281252-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP WALKING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDAK TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDAK TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514927-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12777033</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLIXOTIDE</medicinalproduct>
        <drugdosagetext>DOSAGE FORM = PUFFS</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514928-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12777884</companynumb>
    <primarysource>
      <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>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GATIFLO TABS 100 MG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URETHRITIS CHLAMYDIAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514932-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>UY-SOLVAY-00304004115</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE MALEATE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 100 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514933-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SOLVAY-00304004149</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE MALEATE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514934-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SOLVAY-00204004191</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOPERITONEUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 2 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
        <drugtreatmentduration>3248</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 60 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 10 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
        <drugtreatmentduration>3248</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 25 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
        <drugtreatmentduration>1167</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 160 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
        <drugtreatmentduration>3248</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514940-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19990924</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SOLVAY-00399001310</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3144</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>27.7</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCAPNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLEEN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICES OESOPHAGEAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CREON</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 3 G. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTIC FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 12 MILLILITRE(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTIC FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTERONON-R</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 4 GRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTIC FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYMERON K1</medicinalproduct>
        <drugdosagetext>DAILY DOSE: .6 GRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTIC FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 2 DOSAGE FORM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTIC FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 0.5 GRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTIC FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950620</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514941-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414366FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</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>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPALGIC</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROFENID ^PHARMA RHODIA^</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SKENAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALEORID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514942-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414399FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX 40 MG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPRONIZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRINITRINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAFUSOR</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADANCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRONCHODUAL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS, OTHER COMBINATIONS</medicinalproduct>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAMUDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZALDIAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDYFERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514943-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421692GDDC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE</medicinalproduct>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMAN ACTRAPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514944-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414279FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMPERAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SKENAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514945-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040803</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200412497JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>39.7</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POLITOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>DOSE: 3 TABLETS/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALINAMIN F</medicinalproduct>
        <drugdosagetext>DOSE: 3 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEO-MINOPHAGEN C</medicinalproduct>
        <drugdosagetext>DOSE: 6 TABLETS/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIOFERMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENSURE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514946-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413272JP</companynumb>
    <primarysource>
      <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>CANDIDA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514947-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2004AU01657</companynumb>
    <primarysource>
      <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>DEMENTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAMVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514950-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040316</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR01234</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS PALMARIS AND PLANTARIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COTAREG</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514951-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CA15654</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugbatchnumb>S02700</drugbatchnumb>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514956-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CA15766</companynumb>
    <primarysource>
      <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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>160 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514959-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP14206</companynumb>
    <primarysource>
      <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>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOLATE DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERNICIOUS ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>180 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUBDURAL HAEMORRHAGE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVIATIN</medicinalproduct>
        <drugdosagetext>100 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>6 TO 8 IU</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>8 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>44640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAONIL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514960-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP14368</companynumb>
    <primarysource>
      <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>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERNICIOUS ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
        <drugtreatmentduration>34560</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVIATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514968-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP14919</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANTED KIDNEY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIFE SUPPORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC INFLAMMATORY RESPONSE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>50 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BREDININ</medicinalproduct>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BREDININ</medicinalproduct>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRENOCORTICOTROPHIC HORMONE</medicinalproduct>
        <drugdosagetext>10 MG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514969-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-NOVOPROD-240591</companynumb>
    <primarysource></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>TRIPLE VESSEL BYPASS GRAFT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIXTARD HUMAN 70/30</medicinalproduct>
        <drugdosagetext>12 U, UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514970-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP14919</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANTED KIDNEY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIFE SUPPORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC INFLAMMATORY RESPONSE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>50 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BREDININ</medicinalproduct>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BREDININ</medicinalproduct>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRENOCORTICOTROPHIC HORMONE</medicinalproduct>
        <drugdosagetext>10 MG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514973-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040825</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-SOLVAY-00304003569</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>44.4</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PERITONEAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECURRENT CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELTROXIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 50 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOMETABOLISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CREON</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 6 DOSAGE FORM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
        <drugtreatmentduration>154</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMOL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040216</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514974-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004DE16707</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugdosagetext>20 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CORNEAL OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040507</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugdosagetext>20 MG, DAY 4</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040511</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>250 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORNEAL OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040524</drugenddate>
        <drugtreatmentduration>25920</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514978-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12774345</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
        <drugdosagetext>20MG/2 ML</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPHREN</medicinalproduct>
        <drugdosagetext>2 MG/ML</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514979-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-12771663</companynumb>
    <primarysource>
      <qualification>3</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010404</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4514988-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12426987</companynumb>
    <primarysource>
      <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>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BMS188667</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920506</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515031-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040908</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-BRISTOL-MYERS SQUIBB COMPANY-12697504</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>3 WEEKLY FOR 10 WKS, THEN 4 WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>ORAL/IV</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugdosagetext>IV/ORAL</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LAXATIVE SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040408</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515042-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CH15747</companynumb>
    <primarysource>
      <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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>250 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PADMA 28</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC 325</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHERYL ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515043-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15804</companynumb>
    <primarysource>
      <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>EXANTHEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515048-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040917</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-0409ESP00031</companynumb>
    <primarysource>
      <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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040804</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040804</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040804</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515049-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-0411ESP00035</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515051-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0411AUS00127</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515052-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00539</companynumb>
    <primarysource>
      <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 MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NONSTEROIDAL ANTI-INFLAMMATORY DRUG (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPIPRAMOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOLDENROD</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515053-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00864</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL FAECES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515054-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA00112B1</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDOMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDOMET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515055-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03549</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515056-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12770947</companynumb>
    <primarysource>
      <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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515057-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00088</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATRILIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELIX PLUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMNIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KERLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515058-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12774840</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>CYCLE 1 WEEK 2. THERAPY INITIATED 18-OCT-2004,TOTAL DOSE THIS COURSE 1274 MG-</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>4704MG TOTAL DOSE THIS COURSE,START OF COURSE 18-OCT-GIVEN OVER 46-48HR CONTINUOUS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515059-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03709</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>CARDIAC OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515060-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0410FRA00065</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515061-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0410AUS00242</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIC RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MONARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND ASPIRIN AND CAFFEINE AND HYDROCODONE BITARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MONARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515062-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-MERCK-0411SWE00048</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS, CONJUGATED</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515063-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA00112M</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDOMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDOMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515064-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03561</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515065-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PH-MERCK-0410PHL00002</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515066-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03580</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASOCONSTRICTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515067-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00325</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>123</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030707</drugenddate>
        <drugtreatmentduration>104</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE AND CHOLECALCIFEROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515068-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-MERCK-0411SWE00042</companynumb>
    <primarysource>
      <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>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>1117</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515069-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03706</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515070-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03512</companynumb>
    <primarysource>
      <qualification>5</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515071-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200418784US</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAGOLIDE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>DOSE: 10/12.5</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515072-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200418340US</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DESQUAMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515073-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SEWYE211818NOV04</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</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>4515074-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03807</companynumb>
    <primarysource>
      <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>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515075-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA04358</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIMICROBIAL (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515077-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03854</companynumb>
    <primarysource>
      <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>BRAIN DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515078-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03837</companynumb>
    <primarysource>
      <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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBENECID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515079-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03847</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515080-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US100647</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS GASTROINTESTINAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL LA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</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>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIDOPHILUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515081-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-MERCK-0411MEX00004</companynumb>
    <primarysource>
      <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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>OPEN ANGLE GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>CATARACT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515082-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03813</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515083-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030930</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-AMGEN-US098288</companynumb>
    <primarysource>
      <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>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515084-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US100391</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FAILURE OF IMPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515085-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE215419NOV04</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515086-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040913</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US091331</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>NO ADVERSE DRUG EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515087-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE226423NOV04</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY HILUM MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040606</drugenddate>
        <drugtreatmentduration>1451</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
        <drugtreatmentduration>102</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515088-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-UK096342</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040908</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515089-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US100711</companynumb>
    <primarysource>
      <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515093-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GRWYE208317NOV04</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS ESCHERICHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMEBUTINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515094-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-JNJFOC-20041106488</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONGENITAL GENITAL MALFORMATION MALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYPTORCHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINA BIFIDA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNDACTYLY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAMISOLE</medicinalproduct>
        <drugdosagetext>MOTHER TREATED DUING FIFTH GESTATIONAL MONTH</drugdosagetext>
        <drugindication>ASCARIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515095-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-JNJFOC-20041106675</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL GENITAL MALFORMATION MALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYPTORCHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINA BIFIDA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNDACTYLY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAMISOLE</medicinalproduct>
        <drugdosagetext>MOTHER RECEIVED TREATMENT IN THE SIXTH GESTATIONAL MONTH</drugdosagetext>
        <drugindication>ASCARIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515096-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-JNJFOC-20041106708</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CRYPTORCHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINA BIFIDA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNDACTYLY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAMISOLE</medicinalproduct>
        <drugdosagetext>MOTHER RECEIVED TREATMENT IN SEVENTH GESTATIONAL MONTH</drugdosagetext>
        <drugindication>ASCARIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515097-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004GB15761</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUNCT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>300 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SUNCT SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>700 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>800 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>400 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRMATE</medicinalproduct>
        <drugdosagetext>25 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRMATE</medicinalproduct>
        <drugdosagetext>75 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRMATE</medicinalproduct>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515098-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE226723NOV04</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515099-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03355</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COAPROVEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAXY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OGAST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040629</drugenddate>
        <drugtreatmentduration>18720</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515100-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE218819NOV04</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515101-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NLWYE223722NOV04</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515103-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004ES15812</companynumb>
    <primarysource>
      <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>GASTRECTOMY PARTIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>50 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515104-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20040501308</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMMUNICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONIC CLONIC MOVEMENTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAFON FORTE</medicinalproduct>
        <drugbatchnumb>N219</drugbatchnumb>
        <drugdosagetext>2 DOSES=2 TABLETS</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040502</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515105-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20040607404</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRACHIAL PLEXUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGHT CHAIN ANALYSIS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELOMA RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE ROOT LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORIMOTOR NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEPRONIZINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEPRONIZINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLECAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKENAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515106-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041103983</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOENCEPHALOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBUTEX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIXIVAN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIFLUCAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515107-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041102118</companynumb>
    <primarysource>
      <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>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515109-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE214218NOV04</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515110-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004NZ14512</companynumb>
    <primarysource>
      <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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL - SLOW RELEASE</medicinalproduct>
        <drugdosagetext>150 MG, BIW</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCYCLIDINE HYDROCHLORIDE 2MG TAB</medicinalproduct>
        <drugdosagetext>5 MG, TID, PRN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>23040</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515111-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE03920</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORTICOLLIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515115-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2004AU01663</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEMICAL BURN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEMICAL POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRACHEOSTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELLARIL</medicinalproduct>
        <drugdosagetext>25 TO 50 MG/TID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRAMIL</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE ACETONIDE</medicinalproduct>
        <drugdosagetext>6 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISUDYNE (NVO)</medicinalproduct>
        <drugdosagetext>UNK, ONCE/SINGLE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515117-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041103941</companynumb>
    <primarysource>
      <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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugdosagetext>DOSE: 200-225UG/HR</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
        <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>PROZAC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515123-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE03945</companynumb>
    <primarysource>
      <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>ECZEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINES FOR SYSTEMIC USE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DERMATITIS ATOPIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040310</drugenddate>
        <drugtreatmentduration>17280</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515124-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15895</companynumb>
    <primarysource>
      <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>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>300 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515135-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03434</companynumb>
    <primarysource>
      <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>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515176-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030813</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0422616A</companynumb>
    <primarysource>
      <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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515177-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JPKYO-S-20040033</companynumb>
    <primarysource>
      <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>COMPUTERISED TOMOGRAM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040625</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYCARON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRYPTANOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEFRUSIDE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19730101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515178-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0534636A</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>BRUXISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>37.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515179-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0534660A</companynumb>
    <primarysource>
      <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>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENZYME ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515180-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0534663A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515181-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0534687A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPZICOM</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>3CAP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515182-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>103</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS NONINFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIRECTAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040123</drugenddate>
        <drugtreatmentduration>138</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515183-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0534837A</companynumb>
    <primarysource>
      <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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515184-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JPKYO-S-20040045</companynumb>
    <primarysource>
      <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>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugdosagetext>25MGM2 CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515185-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535071A</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>0.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041024</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugdosagetext>625MG TWICE PER DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041024</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515186-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535210A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>RHINITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAIN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515187-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VIN-04-0442(0)</companynumb>
    <primarysource>
      <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>ELECTROCARDIOGRAM CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
        <drugdosagetext>30MGM2 CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031231</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZOSIN HCL</medicinalproduct>
        <drugdosagetext>1MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515188-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535436A</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugdosagetext>36MG TWICE PER DAY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515190-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535450A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515191-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535456A</companynumb>
    <primarysource>
      <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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515192-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030225</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0293788A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>0</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>2.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNIOTIC FLUID VOLUME DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DOUBLE OUTLET RIGHT VENTRICLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPOSITION OF THE GREAT VESSELS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ECAZIDE</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515193-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040517</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0332913A</companynumb>
    <primarysource>
      <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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040319</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515194-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040517</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0333079A</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>803</patientonsetageunit>
      <patientweight>0.7</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAVENTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040515</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515195-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040810</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0341903A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040715</drugenddate>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040715</drugenddate>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040715</drugenddate>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYSANXIA</medicinalproduct>
        <drugdosagetext>20MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040715</drugenddate>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515196-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040825</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0343895A</companynumb>
    <primarysource>
      <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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING GUILTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELINGS OF WORTHLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040802</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFADIN</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATYPICAL MYCOBACTERIAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATYPICAL MYCOBACTERIAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULGUT</medicinalproduct>
        <drugdosagetext>800MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCTIVE COUGH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYDOXAL</medicinalproduct>
        <drugdosagetext>90MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugdosagetext>1500MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODACIN</medicinalproduct>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515197-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040917</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0345986A</companynumb>
    <primarysource>
      <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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANDSEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515198-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0349721A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugdosagetext>3MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENA</medicinalproduct>
        <drugdosagetext>3TAB WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOTONIC SODIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515204-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0356847A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM DISCOLOURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040810</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIKLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040810</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORELOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040814</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040814</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040814</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SURBRONC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ART 50</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANAKAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515205-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0357307A</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>.4MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515206-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0357320A</companynumb>
    <primarysource>
      <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSE OF OPPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515207-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0357373A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPHREN</medicinalproduct>
        <drugdosagetext>8MG CUMULATIVE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>1.8MGM2 PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYSIOTENS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515208-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0357374A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPHREN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>1.8GM2 PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYSIOTENS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515209-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0357482A</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>2TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEFENAMIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHEMOPHILIC FACTOR (HUMAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515210-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E2004-03702</companynumb>
    <primarysource>
      <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>TALIPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030818</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERMETHRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFLUENZA VACCINE</medicinalproduct>
        <drugbatchnumb>X9575-1</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031016</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515211-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-B0357569A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GW433908</medicinalproduct>
        <drugdosagetext>700MG TWICE PER DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugdosagetext>100MG TWICE PER DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515212-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0357650A</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSTHYMIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040604</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515213-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0357672A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATATONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED SELF-CARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040610</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAROXYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZESTORETIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INIPOMP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040610</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515214-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0357684A</companynumb>
    <primarysource>
      <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>MYOCLONIC EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>25MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEPSAL</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYOCLONUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515215-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0357735A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugindication>POSTPARTUM DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19921101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515217-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0357747A</companynumb>
    <primarysource>
      <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>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>150</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515218-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0357799A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON SULPHATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPEMAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515219-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M24747</companynumb>
    <primarysource>
      <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>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARECOXIB SODIUM</medicinalproduct>
        <drugdosagetext>40MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREOPERATIVE CARE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515220-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0358095A</companynumb>
    <primarysource>
      <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>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACTOR V DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN DEGRADATION PRODUCTS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAMYLASAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLACTACIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MORBILLIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ALKALOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041003</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT D3</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515221-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0358120A</companynumb>
    <primarysource>
      <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>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPHREN</medicinalproduct>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATINE</medicinalproduct>
        <drugdosagetext>510MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>234MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECOTIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugdosagetext>.25UNIT THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN</medicinalproduct>
        <drugdosagetext>6UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SMECTA</medicinalproduct>
        <drugdosagetext>3UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515222-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0358227A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPHREN</medicinalproduct>
        <drugdosagetext>8MG CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>430MG CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugdosagetext>43MG CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>650MG CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040310</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515223-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GLAXOSMITHKLINE-B0358253A</companynumb>
    <primarysource>
      <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 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SELOKEEN</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFONYLUREA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>1.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TILDIEM XR</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515224-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>4751</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYCAMTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515225-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0358381A</companynumb>
    <primarysource>
      <qualification>1</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>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEFIX</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515226-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>386323</companynumb>
    <primarysource>
      <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 CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030912</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACECOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030912</drugenddate>
        <drugtreatmentduration>65</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITOROL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPOVAS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515227-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GLAXOSMITHKLINE-B0358440A</companynumb>
    <primarysource>
      <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>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515228-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0358481A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL VARICES HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGENERASE</medicinalproduct>
        <drugdosagetext>600MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021115</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030130</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugdosagetext>40MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021115</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515229-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRPFM-E-20040127 - V001</companynumb>
    <primarysource>
      <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 UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUNGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIPROFENID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS EXTERNA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040402</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMALINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS EXTERNA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515230-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-GLAXOSMITHKLINE-B0358672A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515274-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041104627</companynumb>
    <primarysource>
      <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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY 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>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KENTAN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>U-PASTA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVACT</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANKARU</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPANDO</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515275-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041105070</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5</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>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515276-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
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    <primarysource>
      <qualification>3</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515277-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041105461</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UTERINE NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMUREL</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4515278-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105878</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>86.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515279-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105953</companynumb>
    <primarysource>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515280-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20040906309</companynumb>
    <primarysource>
      <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>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOPERITONEUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIPROFENID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINZIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINZIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKENAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUPHALAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugdosagetext>1/2 IN 1 DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX 0.4</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515282-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041101804</companynumb>
    <primarysource>
      <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>TRIPLE VESSEL BYPASS GRAFT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515283-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20040900020</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>7.5 - 10MG EVERY WEEK.</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515284-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041102173</companynumb>
    <primarysource>
      <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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>4515296-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
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    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <qualification>3</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>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugdosagetext>THERAPY INTERRUPTED ON 18-NOV-2004</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030319</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGENERASE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030319</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030319</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030319</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990501</drugstartdate>
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  <safetyreport>
    <safetyreportid>4515298-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
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      <qualification>1</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>ABDOMINAL PAIN</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugdosagetext>375 UG/DAY</drugdosagetext>
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        <drugindication>ABORTION SPONTANEOUS</drugindication>
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        <drugstartdate>20041022</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHERGINE</medicinalproduct>
        <drugdosagetext>1 DF, ONCE/SINGLE</drugdosagetext>
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        <drugstartdate>20041113</drugstartdate>
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        <drugenddate>20041113</drugenddate>
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  </safetyreport>
  <safetyreport>
    <safetyreportid>4515299-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-NOVOPROD-240636</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>24 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID FLEXPEN</medicinalproduct>
        <drugdosagetext>36 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STESOLID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STESOLID</medicinalproduct>
        <drugdosagetext>OVERDOSE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515300-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040310</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-BRISTOL-MYERS SQUIBB COMPANY-12529954</companynumb>
    <primarysource>
      <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>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABATACEPT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020626</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515301-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12776464</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040511</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTRICITABINE</medicinalproduct>
        <drugdosagetext>INTERRUPTED ON 04-MAR-2004, RESTARTED ON 23-SEP-2004.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515303-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12774832</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIVENTRICULAR LEUKOMALACIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIIITH NERVE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>INITIATED 30-SEP-04. 400 MG/M2 ON DAY 1, 250 MG/M2 WEEKLY THEREAFTER. TOTAL DOSE ADMIN. 2720MG.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>INITIATED ON 30-SEP-04. TOTAL DOSE ADMINISTERED THIS COURSE=1053MG.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>INITIATED ON 30-SEP-04. TOTAL DOSE ADMINISTERED THIS COURSE= 2340 MG.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>INITIATED ON 30-SEP-04. 400 BOLUS, THEN 2400 Q2WKS. TOTAL DOSE ADMINISTERED THIS COURSE=10140MG.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515304-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040907</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BRISTOL-MYERS SQUIBB COMPANY-12697751</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515306-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040818</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-BRISTOL-MYERS SQUIBB COMPANY-12674230</companynumb>
    <primarysource>
      <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>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040326</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040326</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>27-MAR TO 29-MAR-04, 03-APR TO 05-APR-04, AND 10-APR TO 12-APR-04</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM HYDROXIDE TAB</medicinalproduct>
        <drugindication>HYPOMAGNESAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040511</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515307-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12774824</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JUGULAR VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENA CAVA THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>236 MG/TOTAL ADMINISTERED THIS COURSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>5264 MG/TOTAL ADMINISTERED THIS COURSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugdosagetext>752 MG/TOTAL ADMINISTERED THIS COURSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>338 MG/TOTAL ADMINISTERED THIS COURSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515353-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030625</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-ROCHE-340806</companynumb>
    <primarysource>
      <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>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES PALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</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>20030303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040126</drugenddate>
        <drugtreatmentduration>330</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
        <drugtreatmentduration>336</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIURAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRAMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STILNOCT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELTROXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030628</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515355-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-383986</companynumb>
    <primarysource>
      <qualification>1</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCYRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAKKON-TO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL STIFFNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040807</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515357-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-383891</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040604</drugenddate>
        <drugtreatmentduration>73</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYOSTACINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040505</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYOSTACINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040604</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugdosagetext>TAKEN DAILY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOXID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040604</drugenddate>
        <drugtreatmentduration>73</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLTUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>0.25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECTOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVONORM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFRAREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROKINYL LP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515358-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030923</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ROCHE-347645</companynumb>
    <primarysource>
      <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>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030407</drugenddate>
        <drugtreatmentduration>330</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030412</drugenddate>
        <drugtreatmentduration>335</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515361-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040816</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-377770</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TINNITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940615</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515362-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-386774</companynumb>
    <primarysource>
      <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>GENITAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
        <drugtreatmentduration>119</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515364-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-386903</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>130.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QRS AXIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031121</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031121</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031121</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GELUSIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031121</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515365-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-387047</companynumb>
    <primarysource>
      <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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515368-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-386289</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA-2A</medicinalproduct>
        <drugdosagetext>6 MILLIONU/M2 ONCE A WEEK ON WEEK ONE+ FOUR AND THRICE WEEKLY ON WEEK 2 + 3.  CUMULATIVE DO+</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA-2A</medicinalproduct>
        <drugdosagetext>6 MILLIONU/M2 ONCE A WEEK ON WEEK ONE+ FOUR AND THRICE WEEKLY ON WEEK 2 + 3.  CUMULATIVE DO+</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERLEUKIN-2</medicinalproduct>
        <drugdosagetext>10 MILLIONU/M2 ON DAY THREE FOR THREE DAYS ON WEEK 1 + 4 AND 5MILLIONU/M2 THRICE WEEKLY ON WEEK+</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERLEUKIN-2</medicinalproduct>
        <drugdosagetext>10 MILLIONU/M2 ON DAY THREE FOR THREE DAYS ON WEEK 1 + 4 AND 5MILLIONU/M2 THRICE WEEKLY ON WEEK+</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>5-FU</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515370-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-386374</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL MUCOSAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>ROUTE: INJECTION</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515371-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-387332</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515373-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-387348</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515375-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ROCHE-387111</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBILEUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIMOXAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515377-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-387058</companynumb>
    <primarysource>
      <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>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515379-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-386971</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugdosagetext>DOSAGE REGIMEN: PER WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515381-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-387369</companynumb>
    <primarysource>
      <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>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515382-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-387378</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</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>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515451-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040824</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP11286</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN UNCONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040428</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>200 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>150 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040503</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>1 G/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040506</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAN</medicinalproduct>
        <drugdosagetext>450 MG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040604</drugenddate>
        <drugtreatmentduration>53280</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>30 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>0.53 MG/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040530</drugenddate>
        <drugtreatmentduration>36000</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>2.5-1.5 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040531</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515461-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004IN15649</companynumb>
    <primarysource>
      <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>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TETANY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D3</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515462-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15202</companynumb>
    <primarysource>
      <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>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASKED FACIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>400 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MANIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXOPROFEN</medicinalproduct>
        <drugdosagetext>180 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE MALEATE</medicinalproduct>
        <drugdosagetext>75 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAPROTILINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>25 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAPROTILINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>12.5-25 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugdosagetext>180 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515486-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12637</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>UNK/UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515488-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CH15624</companynumb>
    <primarysource>
      <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>POLYSEROSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515517-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040226</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0251566-00</companynumb>
    <primarysource></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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION PSEUDOMONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA CYTOMEGALOVIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXOPLASMA SEROLOGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040220</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPRANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040221</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040221</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515518-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0247515-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010424</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPRANAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010424</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugdosagetext>800 MILLIGRAM</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugdosagetext>400 MGS</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugdosagetext>400 MGS.</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515519-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ABBOTT-04P-144-0281539-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPRANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPRANAVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515520-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0281436-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
        <drugtreatmentduration>44</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515522-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ABBOTT-04P-083-0281025-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>BRONCHIOLITIS</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACINA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACINA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>BRONCHIOLITIS</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALIFLUS 25/125 MCG</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515523-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0281441-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</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 BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPANTHYL TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
        <drugtreatmentduration>176</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOSULEPIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFLOMEDIL HYDROCHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
        <drugtreatmentduration>421</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUINDIONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUINDIONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYAMEMAZINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515525-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-04P-087-0278288-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugbatchnumb>17502YQ</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>53</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
        <drugtreatmentduration>53</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>53</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </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>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>3MGX3 + 2MGX1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIHEXYPHENIDYL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISTIGMINE BROMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515526-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0281513-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>INTERNATIONAL NORMALISED RATIO</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>INTERNATIONAL NORMALISED RATIO</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MITRAL VALVE REPAIR</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</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>CLAVULIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515527-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0249822-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS CHORIORETINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA CYTOMEGALOVIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>LOPINAVIR 800 MG/RITONAVIR 200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040127</drugenddate>
        <drugtreatmentduration>172</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</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>ITRACONAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515529-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040924</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0274756-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOCAPNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
        <drugtreatmentduration>146</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040903</drugenddate>
        <drugtreatmentduration>712</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODUCREN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMMERCIAL HUMIRA</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
        <drugtreatmentduration>328</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515667-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0312USA00367</companynumb>
    <primarysource>
      <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 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLORINEF</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515669-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-MERCK-0411GBR00262</companynumb>
    <primarysource>
      <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>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515670-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-MERCK-0411BEL00014</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMALACIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515671-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0411AUS00043</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOTHIEPIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515672-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-MERCK-0411GBR00255</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515673-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0411AUS00244</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515676-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00513</companynumb>
    <primarysource>
      <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>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUSOPT</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515684-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00690</companynumb>
    <primarysource>
      <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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS NONINFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC PH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIC BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CERVICOBRACHIAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515690-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0411CAN00221</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040428</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515692-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0301USA01091</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL SKIN TAGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROCYSTIC BREAST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020515</drugenddate>
        <drugtreatmentduration>419</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515693-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0411FRA00103</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIXIVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGEAL CANDIDIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515695-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA04188</companynumb>
    <primarysource>
      <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>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515696-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-MERCK-0411SWE00061</companynumb>
    <primarysource>
      <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>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515698-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040709</drugstartdate>
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        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515700-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <qualification>1</qualification>
    </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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040330</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040330</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515701-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00234</companynumb>
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      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515707-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00275</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>4515708-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0301USA03189</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INGROWING NAIL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
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        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010325</drugenddate>
        <drugtreatmentduration>53</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
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        <drugenddate>20010101</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010325</drugenddate>
        <drugtreatmentduration>53</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRODIURIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515713-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
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    <companynumb>DE-MERCK-0410DEU00217</companynumb>
    <primarysource>
      <qualification>1</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000718</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000718</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>4515714-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00511</companynumb>
    <primarysource>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSEUDARTHROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031105</drugstartdate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALMOTRIPTAN MALATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE WITHOUT AURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030305</drugstartdate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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  <safetyreport>
    <safetyreportid>4515715-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-0410ESP00003</companynumb>
    <primarysource>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERIARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040910</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
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  <safetyreport>
    <safetyreportid>4515716-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedateformat>102</receivedateformat>
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    <receiptdate>20041122</receiptdate>
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    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC PROTRUSION</drugindication>
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        <drugstartdate>20000101</drugstartdate>
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  <safetyreport>
    <safetyreportid>4515719-1</safetyreportid>
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    <receivedateformat>102</receivedateformat>
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    <receiptdate>20041111</receiptdate>
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    <primarysource>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>ANOXIC ENCEPHALOPATHY</reactionmeddrapt>
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        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
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        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
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        <drugcharacterization>1</drugcharacterization>
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      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515721-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00517</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515723-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00087</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTESTINAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPIPRAMOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040327</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515724-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00765</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>114</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BASILAR ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTEBRAL ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515725-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00480</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515728-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0411FRA00047</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515729-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03589</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[COMPOSITION UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515732-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA01677</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515733-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03556</companynumb>
    <primarysource>
      <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040903</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD THINNER (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515734-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03481</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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>4515736-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
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    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03523</companynumb>
    <primarysource>
      <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>HAEMOPTYSIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
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  </safetyreport>
  <safetyreport>
    <safetyreportid>4515737-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
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    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03554</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVE COMPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515745-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04009</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515747-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03931</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515748-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03848</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515749-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03527</companynumb>
    <primarysource>
      <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>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515750-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03998</companynumb>
    <primarysource>
      <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515751-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03870</companynumb>
    <primarysource>
      <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 WALL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515753-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03592</companynumb>
    <primarysource>
      <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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515754-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04014</companynumb>
    <primarysource>
      <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>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515755-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0411GBR00257</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515756-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03590</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020201</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFLUENZA VIRUS VACCINE (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515757-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03873</companynumb>
    <primarysource>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
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        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
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        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515758-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03814</companynumb>
    <primarysource>
      <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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515760-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040303</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0403USA00661</companynumb>
    <primarysource>
      <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>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC URAEMIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040303</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICAFUNGIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040303</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILGRASTIM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040302</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040302</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040308</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SHOCK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040308</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040308</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SHOCK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040308</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515761-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0411FRA00109</companynumb>
    <primarysource>
      <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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031216</drugenddate>
        <drugtreatmentduration>411</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031216</drugenddate>
        <drugtreatmentduration>1660</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515763-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03263</companynumb>
    <primarysource>
      <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>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINO ACIDS (UNSPECIFIED) AND CARBOHYDRATES (UNSPECIFIED) AND ELECTROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515790-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA04051</companynumb>
    <primarysource>
      <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>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRUFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZULENE SULFONATE SODIUM AND LEVOGLUTAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515797-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03477</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515804-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03598</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[COMPOSITION UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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    </patient>
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  <safetyreport>
    <safetyreportid>4515931-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>C-04-0063</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TANNIHIST-12 RF SUSPENSION</medicinalproduct>
        <drugbatchnumb>25689A</drugbatchnumb>
        <drugdosagetext>1 TSP., ORALLY, AS NEEDED</drugdosagetext>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TANNIHIST-12 RF SUSPENSION</medicinalproduct>
        <drugbatchnumb>25689A</drugbatchnumb>
        <drugdosagetext>1 TSP., ORALLY, AS NEEDED</drugdosagetext>
        <drugindication>RESPIRATORY TRACT CONGESTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>4515933-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096039</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION PSEUDOMONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE (MENTHOL, METHYL SALICYLATE, EUCALYPTOL, THYMOL)</medicinalproduct>
        <drugdosagetext>A MOUTHFUL TWICE A DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DENTAL DISORDER PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODAFINIL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULOXETINE HYDROCHLORIDE (DULOXETINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515934-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1003461</companynumb>
    <primarysource>
      <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>METOPROLOL TARTRATE</medicinalproduct>
        <drugauthorizationnumb>73666</drugauthorizationnumb>
        <drugdosagetext>25MG, QD, THEN 50MG, QS, 75MG QD, 100MG QD, 100MG BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515935-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1003417</companynumb>
    <primarysource></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>CHOKING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>200MG BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>200MG BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515936-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1003460</companynumb>
    <primarysource>
      <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>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugbatchnumb>1L2927</drugbatchnumb>
        <drugauthorizationnumb>73666</drugauthorizationnumb>
        <drugdosagetext>100MG QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART RATE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIATMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515937-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AL000984</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugbatchnumb>535H31</drugbatchnumb>
        <drugauthorizationnumb>75910</drugauthorizationnumb>
        <drugdosagetext>100 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENEST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515977-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>E-04-034</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTURING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIBID  LA TABLETS, VINTAGE</medicinalproduct>
        <drugdosagetext>T -TT  P.O. B.I.D.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAITRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRYPTILINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMASEDAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515980-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20041106393</companynumb>
    <primarysource>
      <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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugdosagetext>NINE DOSES SINCE JAN-02.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515986-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PANC00304003951</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANCREATIN TRIPLE STRENGTH CAP</medicinalproduct>
        <drugdosagetext>2 GRAM (S) TID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTIC FIBROSIS PANCREATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANVITAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYMERON KI (PHYTOMENADIONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA (TOCOPHEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOLVON (BROMHEXINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE (CARBOCISTEINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL (ALFACALCIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOCHU-EKKI-TO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515987-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004.1773</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHAEOCHROMOCYTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugauthorizationnumb>74478</drugauthorizationnumb>
        <drugdosagetext>SINGLE DOSE</drugdosagetext>
        <drugindication>VOMITING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515988-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004.1777</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugauthorizationnumb>18569</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugauthorizationnumb>18569</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>400 MG TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>10 MG ORALLY DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLEXANE (ENOXAPARIN)</medicinalproduct>
        <drugdosagetext>400 MG SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE (FLUTICASONE/SALMETEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL (PARACETAMOL; 1 G QDS, ORAL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCLOXACILLIN (FLUCLOXACILLIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZYLPENICILLIN (BENZYLPENICILLIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSATATIN (NYSTATIN, 1 ML QDS, ORAL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4515989-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004.1772</companynumb>
    <primarysource></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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIBODY TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONOSCOPY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>64076</drugauthorizationnumb>
        <drugdosagetext>1 G DAILY</drugdosagetext>
        <drugindication>DENTAL DISORDER PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516127-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB03833</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>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL SPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugdosagetext>3 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CO-CARELDOPA</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516138-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugdosagetext>SUSPENSION</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516140-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugdosagetext>TABLET</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>TABLET</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516141-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ABBOTT-04P-144-0280241-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS NEUROSENSORY</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>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516142-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030514</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-03P-056-0218902-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCAPNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040521</drugenddate>
        <drugtreatmentduration>399</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030521</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030522</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030502</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPRENAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030521</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugindication>CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030516</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030522</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugindication>ANTIBACTERIAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030502</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516143-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID SYRUP</medicinalproduct>
        <drugdosagetext>LIQUID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
        <drugdosagetext>SUSPENSION</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516144-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugbatchnumb>B10555</drugbatchnumb>
        <drugdosagetext>CAPSULE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516145-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACE ELEMENT-ZINC CHLORIDE</medicinalproduct>
        <drugdosagetext>1 ML PER DOSE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516146-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIPEN JR.</medicinalproduct>
        <drugdosagetext>INJECTABLE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIPEN</medicinalproduct>
        <drugdosagetext>INJECTABLE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516147-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>TABLET</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516148-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugdosagetext>IV SOLUTION</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516149-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN L</medicinalproduct>
        <drugdosagetext>INJECTION SUB Q</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516150-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>TABLET</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>INJECTION SUB Q</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516151-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>INJECTION-SUB Q</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516152-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>INJECTION</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516154-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugdosagetext>CAPSULE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516156-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>50 MG TOPROL ONCE ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>100 MG ONCE ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516158-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROBITUSSIN DM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516159-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SKELACTIN 750 MG</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK INJURY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516161-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-11956745</companynumb>
    <primarysource>
      <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>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516162-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12766820</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>125</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516163-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUN TUSSIN SUGAR FREE DISTRIBUTED BY MCKESSON</medicinalproduct>
        <drugbatchnumb>3JK0094</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516164-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12777173</companynumb>
    <primarysource>
      <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>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041003</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COAPROVEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041003</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FERVEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041003</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041003</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516166-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413552JP</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>38</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL AMYLOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEDERCORT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVEN EP</medicinalproduct>
        <drugdosagetext>DOSE: 3 CAPS/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONALON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516167-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200412529FR</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPALGIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516168-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANGLOBULIN</medicinalproduct>
        <drugbatchnumb>04588-00050</drugbatchnumb>
        <drugdosagetext>100 GRAMS IV DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMOLYTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANGLOBULIN</medicinalproduct>
        <drugbatchnumb>03610-00072</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLASETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLO 9 MIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516170-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>ARTHRITIS INFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TISSUE FOR ACL TISSUE BANK</medicinalproduct>
        <drugbatchnumb>SF0405006008</drugbatchnumb>
        <drugindication>LIGAMENT DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516171-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TISSUE FOR ACL TISSUE BANK INTERNATIONAL</medicinalproduct>
        <drugbatchnumb>CA0404019007</drugbatchnumb>
        <drugindication>LIGAMENT DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TISSUE FOR ACL TISSUE BANK INTERNATIONAL</medicinalproduct>
        <drugbatchnumb>CA0404019007</drugbatchnumb>
        <drugindication>SURGERY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516179-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12772265</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>REFRACTORY ANAEMIA WITH AN EXCESS OF BLASTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>6 CYCLES: MAY-OCT-01; 6 CYCLES: JUN-NOV-02; 5 CYCLES: JAN-APR-04</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPREX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021104</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516183-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12775961</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDREA</medicinalproduct>
        <drugdosagetext>START DATE:  UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030927</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516184-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20040602002</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS NOS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOSAPRIDE CITRATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITOPRIDE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RILMAZAFONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECABET SODIUM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEPRENONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM ALGINATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE HCL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMEZINIUM METILSULFATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMEZINIUM METILSULFATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ORTHOSTATIC HYPOTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAVOXATE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAVOXATE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>POLLAKIURIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516185-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20041103326</companynumb>
    <primarysource>
      <qualification>1</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPULSID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACENTERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTAZINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTAZINE</medicinalproduct>
        <drugdosagetext>1/2 TABLET/DAY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugdosagetext>4X1/2 WEEKLY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORUNO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISTRANEURIN</medicinalproduct>
        <drugdosagetext>1 DOSE NOCTURNAL</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELDEPRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAMET</medicinalproduct>
        <drugdosagetext>2 MG NOCTURNAL</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET CONTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET CONTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANIDIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516186-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20040701197</companynumb>
    <primarysource>
      <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>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISAPRIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516193-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105794</companynumb>
    <primarysource>
      <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>DIFFUSE LARGE B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETERIC OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516204-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20040904715</companynumb>
    <primarysource>
      <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>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>1 DAILY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOSAPRIDE CITRATE</medicinalproduct>
        <drugdosagetext>3 DAILY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTETHINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE-LAXATIVE</medicinalproduct>
        <drugdosagetext>1 DAILY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA LEAF AND SENNA POD</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>1 DAILY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugdosagetext>1 DAILY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516205-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040528</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-12599296</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516206-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-12776225</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLATINEX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARCINOID TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040519</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCTREOTIDE</medicinalproduct>
        <drugdosagetext>DRUG NOT ADMINISTERED</drugdosagetext>
        <drugindication>CARCINOID TUMOUR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASTET</medicinalproduct>
        <drugindication>CARCINOID TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040519</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516208-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421475GDDC</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516225-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN SOCIAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF DESPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext> 1      PER DAY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>1       PER DAY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040313</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516226-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CA15758</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516227-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US11461</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OCCULT BLOOD POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>30 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>UNK, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516229-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.3993</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE AFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NARDIL</medicinalproduct>
        <drugbatchnumb>4018601</drugbatchnumb>
        <drugdosagetext>15 MG 3X DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NARDIL</medicinalproduct>
        <drugbatchnumb>4018601</drugbatchnumb>
        <drugdosagetext>15 MG 3X DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516232-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE 500 MG</medicinalproduct>
        <drugdosagetext>1000 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARATHYROIDECTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
        <drugdosagetext>0.25 MG TID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARATHYROIDECTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516235-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12634</companynumb>
    <primarysource>
      <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>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, TID</drugdosagetext>
        <drugindication>IMPAIRED GASTRIC EMPTYING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516240-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-12771598</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516241-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12776852</companynumb>
    <primarysource>
      <qualification>1</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DASEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE-A</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITOROL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHYTHMY</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOKUNALIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031217</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516243-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DELAYED RECOVERY FROM ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMURON</medicinalproduct>
        <drugbatchnumb>1805303450</drugbatchnumb>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMURON</medicinalproduct>
        <drugbatchnumb>3299804264</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516244-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.4827</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugdosagetext>10 MG PO Q 4 PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516247-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMILA</medicinalproduct>
        <drugdosagetext>1 Q DAY</drugdosagetext>
        <drugindication>MENSTRUAL DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516279-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-JNJFOC-20041104896</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARGININOSUCCINATE SYNTHETASE DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT SPASTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL AND CODEINE</medicinalproduct>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516281-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20041102757</companynumb>
    <primarysource>
      <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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</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>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516282-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20041106758</companynumb>
    <primarysource>
      <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>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER PYLORI IDENTIFICATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PSEUDOEPHEDRINE HCL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516298-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041106089</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516299-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20041106146</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPULSID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DIABETIC GASTROPARESIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROVEL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOPRAID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516316-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB03923</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020805</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516317-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03345</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFERTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPERMATOZOA PROGRESSIVE MOTILITY ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>1200 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516318-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040405</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0505944A</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>875MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CELLULITIS</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516319-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040405</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0505947A</companynumb>
    <primarysource>
      <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>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>875MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040325</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516320-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0506850A</companynumb>
    <primarysource>
      <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>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040406</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516322-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040414</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0507195A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>.5MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040523</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516323-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0507241A</companynumb>
    <primarysource>
      <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>AUGMENTIN '125'</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516324-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040421</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0507898A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>875MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516325-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040506</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0509829A</companynumb>
    <primarysource>
      <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>ENURESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>875MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516326-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040514</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>S04-USA-02595-01</companynumb>
    <primarysource>
      <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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516327-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040517</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0511030A</companynumb>
    <primarysource>
      <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>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516328-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0511393A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPROSPAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516329-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040525</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0512097A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SKIN INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516330-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040603</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0513280A</companynumb>
    <primarysource>
      <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>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>1TSP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040603</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516331-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040611</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0514320A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040617</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516333-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040611</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0514632A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516334-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0514671A</companynumb>
    <primarysource>
      <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</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>875MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040613</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516335-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0516913A</companynumb>
    <primarysource>
      <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>URINE KETONE BODY PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040702</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516336-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040708</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0517417A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516337-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040708</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0517427A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>2TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040712</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040623</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516338-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0517877A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516339-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040715</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0518541A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TONGUE BLACK HAIRY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516340-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0519702A</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>875MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516341-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0519876A</companynumb>
    <primarysource>
      <qualification>5</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>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>875MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516342-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0520324A</companynumb>
    <primarysource>
      <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>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>875MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040728</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516343-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0520896A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516344-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0523309A</companynumb>
    <primarysource>
      <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>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>875MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040529</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516345-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0525413A</companynumb>
    <primarysource>
      <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>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516346-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004058073</companynumb>
    <primarysource>
      <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>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SKIN INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL ALLERGY</medicinalproduct>
        <drugdosagetext>1TBS THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516347-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004/03764</companynumb>
    <primarysource>
      <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>HOARSENESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTH INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040822</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugdosagetext>250MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTH INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC EFFECT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040822</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516348-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0526710A</companynumb>
    <primarysource>
      <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>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040509</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516349-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0527402A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516350-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0527977A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516351-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>20040902470</companynumb>
    <primarysource>
      <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>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIZORAL</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>.625MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALDECOXIB</medicinalproduct>
        <drugdosagetext>20MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516353-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040407</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0506250A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN ES-600</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516354-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0506808A</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>1TSP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS MEDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040406</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516355-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040416</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0507466A</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN ES-600</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516356-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0507884A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>TOOTH DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN ES-600</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516357-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040423</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0508221A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN ES-600</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516358-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0509462A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516359-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040513</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0510735A</companynumb>
    <primarysource>
      <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>AUGMENTIN ES-600</medicinalproduct>
        <drugdosagetext>1.5TSP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040513</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516360-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040514</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0510941A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE STOOLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTICATION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN ES-600</medicinalproduct>
        <drugdosagetext>.75TSP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040510</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516361-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040520</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0511600A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUNBURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516362-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040525</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0512214A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN ES-600</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516363-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040603</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0513262A</companynumb>
    <primarysource>
      <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>DERMATITIS DIAPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN ES-600</medicinalproduct>
        <drugdosagetext>600MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040512</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516364-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040604</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0513453A</companynumb>
    <primarysource>
      <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>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN ES-600</medicinalproduct>
        <drugdosagetext>1TSP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040603</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516365-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0513617A</companynumb>
    <primarysource>
      <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>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN ES-600</medicinalproduct>
        <drugdosagetext>1TSP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR INFECTION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516366-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0513632A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516367-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0514502A</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN ES-600</medicinalproduct>
        <drugdosagetext>4ML TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516368-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040621</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0515368A</companynumb>
    <primarysource>
      <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>DERMATITIS DIAPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN ES-600</medicinalproduct>
        <drugdosagetext>2TSP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040616</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516369-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040621</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0515420A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN ES-600</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516370-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040622</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0515605A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN ES-600</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040619</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516371-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040623</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0516144A</companynumb>
    <primarysource>
      <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>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN ES-600</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040528</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516372-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040721</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0519233A</companynumb>
    <primarysource>
      <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>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040721</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516373-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040721</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0519360A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040721</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516374-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040805</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0521110A</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN ES-600</medicinalproduct>
        <drugdosagetext>1TSP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040724</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516375-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040805</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0521111A</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN ES-600</medicinalproduct>
        <drugdosagetext>1TSP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040724</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516376-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0521382A</companynumb>
    <primarysource>
      <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>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN ES-600</medicinalproduct>
        <drugdosagetext>.5TSP TEN TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040731</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516377-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0523046A</companynumb>
    <primarysource>
      <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>AUGMENTIN ES-600</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516378-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0524497A</companynumb>
    <primarysource>
      <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>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN ES-600</medicinalproduct>
        <drugdosagetext>1TSP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUGH MEDICINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516379-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0524511A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN ES-600</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516380-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0526016A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM SICKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN ES-600</medicinalproduct>
        <drugdosagetext>.5TSP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040904</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516381-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0526190A</companynumb>
    <primarysource>
      <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>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516382-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0527617A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN ES-600</medicinalproduct>
        <drugdosagetext>5ML TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516384-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0522255A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>400MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040808</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516386-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0508559A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516387-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0520915A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>11.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTH DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN ES-600</medicinalproduct>
        <drugdosagetext>5ML TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS MEDIA ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040322</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516389-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200418968US</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 400MG / 2 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516390-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414330FR</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA PSYCHOGENIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEMI-DAONIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516391-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414416FR</companynumb>
    <primarysource>
      <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>MELANODERMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SIGMOIDITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516392-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421697GDDC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED MAN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS BACTERIAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCLOXACILLIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DANAPAROID</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DEEP VENOUS THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516393-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421703GDDC</companynumb>
    <primarysource></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>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTH ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516394-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414454FR</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROSMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IZILOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DERINOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040616</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516395-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421721GDDC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516396-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200420698GDDC</companynumb>
    <primarysource>
      <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>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMAUROSIS FUGAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMESULIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBROXOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031026</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516397-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040908</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200416774US</companynumb>
    <primarysource>
      <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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 2 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>CONDITION AGGRAVATED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIINFLAMMATORY/ANTIRHEUMATIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516398-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414236FR</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCOMMODATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMAUROSIS FUGAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>TONSILLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROFENID</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516399-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200418260US</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>1055237</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040822</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugindication>CYSTITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM CITRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516400-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE03686</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPERONE</medicinalproduct>
        <drugdosagetext>25 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMIPRAMINE</medicinalproduct>
        <drugdosagetext>75 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>150 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEDICATION ERROR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516401-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040405</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0505952A</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE STOOLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>1TAB THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE SINUSITIS</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516402-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040407</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0506253A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>2TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516403-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040407</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0506254A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>2TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516404-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040407</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0506255A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>2TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516405-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040409</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0506513A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NONSPECIFIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516406-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040409</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0506514A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugbatchnumb>[NOT ENTERED]</drugbatchnumb>
        <drugdosagetext>2TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCURRENT MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516407-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0506857A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>2G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516408-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0506948A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516409-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040414</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0507190A</companynumb>
    <primarysource>
      <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 HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040411</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516410-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040415</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0507246A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040413</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIA 1/35E-21</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516411-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040415</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0507251A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516412-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0507555A</companynumb>
    <primarysource>
      <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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>2TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516413-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040416</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0507619A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN XR</medicinalproduct>
        <drugdosagetext>62.5MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516414-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040421</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0507924A</companynumb>
    <primarysource>
      <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>2G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SKIN INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040416</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516415-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040422</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0508329A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516416-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040429</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0508963A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BILIARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>2TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516417-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0509436A</companynumb>
    <primarysource>
      <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>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>2000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040503</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ST. JOHN'S WORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516418-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0509448A</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SKIN INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040503</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516419-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040507</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0510129A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>URINE ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516420-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040512</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0510556A</companynumb>
    <primarysource>
      <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>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040509</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516421-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040513</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0510724A</companynumb>
    <primarysource>
      <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>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>2TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040510</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM MVI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIACTIV</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516422-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040514</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0510905A</companynumb>
    <primarysource>
      <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>2TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516423-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040520</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0511634A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOOLS WATERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>1000MG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040520</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516424-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040521</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0511745A</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>2TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SKIN INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516425-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040526</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0512385A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516426-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040528</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0512625A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>120</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL FAECES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>2000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516427-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040608</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0513806A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETANUS SHOT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516428-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040609</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0513958A</companynumb>
    <primarysource>
      <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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>2G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OESTROGEN PATCHES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516429-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040608</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0514125A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM SICKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>2TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040413</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516430-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0514529A</companynumb>
    <primarysource>
      <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>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugbatchnumb>WW0472</drugbatchnumb>
        <drugdosagetext>1000MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516431-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0515033A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>2TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516432-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040621</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0515360A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SKIN INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030617</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516433-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040621</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0515391A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516434-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040621</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0515398A</companynumb>
    <primarysource>
      <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>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>2TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040621</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516435-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040621</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0515419A</companynumb>
    <primarysource>
      <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>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN ES-600</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516436-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040622</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0515588A</companynumb>
    <primarysource>
      <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>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516437-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040621</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0515705A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516438-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0517057A</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TESTOSTERONE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN XR</medicinalproduct>
        <drugdosagetext>2TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040405</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516439-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0517664A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>2G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SKIN INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040707</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516440-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0518081A</companynumb>
    <primarysource>
      <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>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCURRENT MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516441-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0518254A</companynumb>
    <primarysource>
      <qualification>1</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>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>2TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTH ABSCESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516442-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040715</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0518922A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516443-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0520010A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CELLULITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516444-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0520011A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>4000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUS DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516445-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0520735A</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>2TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516446-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0520750A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>177.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>2000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CELLULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040803</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516447-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0522787A</companynumb>
    <primarysource>
      <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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>2TAB THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS MEDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040818</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516448-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040820</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0522932A</companynumb>
    <primarysource>
      <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>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO-NOVUM 7/7/7-21</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516449-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0523044A</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>2TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040822</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>60MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>50MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT AQ</medicinalproduct>
        <drugdosagetext>2SPR TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516450-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0523637A</companynumb>
    <primarysource>
      <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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516451-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0524766A</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>2TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE SINUSITIS</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516452-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0525079A</companynumb>
    <primarysource>
      <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>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>2TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE SINUSITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORINAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON SUPPLEMENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516453-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0525810A</companynumb>
    <primarysource>
      <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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040908</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516454-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0526665A</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA-D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516455-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0527421A</companynumb>
    <primarysource>
      <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>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SKIN INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTAURY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516456-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0527786A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugindication>CHRONIC SINUSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516457-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0527958A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040925</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516458-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0527959A</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>2000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040925</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516459-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE03934</companynumb>
    <primarysource>
      <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>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCINTILLATING SCOTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD TESTS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516464-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12774444</companynumb>
    <primarysource>
      <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>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AXEPIM INJ</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040922</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIFLOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYPNOVEL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>INTERRUPTED FROM 21- TO 23-SEP-2004</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOMYST</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMBEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516466-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP13956</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>35</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugdosagetext>30 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>30 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOLAN</medicinalproduct>
        <drugdosagetext>2 DF/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPEN</medicinalproduct>
        <drugdosagetext>400 MG/D</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516467-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004DE14649</companynumb>
    <primarysource>
      <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>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHAMBERG'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516468-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15644</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCULUS URETERIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugdosagetext>70 TO 80 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516475-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP13007</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040616</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516481-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US098092</companynumb>
    <primarysource>
      <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>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
        <drugtreatmentduration>589</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516490-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US100662</companynumb>
    <primarysource>
      <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>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>P026110</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516492-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE127120OCT04</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IRIDOCYCLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040908</drugenddate>
        <drugtreatmentduration>148</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516523-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BRISTOL-MYERS SQUIBB COMPANY-11930310</companynumb>
    <primarysource>
      <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>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BMS188667</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS A + D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19891001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDRONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516528-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12777116</companynumb>
    <primarysource>
      <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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATATONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>0.5/DAY = DOSAGE FORM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELISOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERESTA</medicinalproduct>
        <drugdosagetext>0.5 TWICE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516532-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE110514OCT04</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAIL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>188</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516533-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE154328OCT04</companynumb>
    <primarysource>
      <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>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516554-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NLWYE077230SEP04</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516555-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-239810</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTERIAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN I INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>3 DOSES (Q2 H)</drugdosagetext>
        <drugindication>OPERATIVE HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
        <drugtreatmentduration>242</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>1 TAB, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
        <drugdosagetext>1 GTT, QD</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANCEF</medicinalproduct>
        <drugdosagetext>2 G, BID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIBACTERIAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
        <drugtreatmentduration>276</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>750 UG, QD</drugdosagetext>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPHEDRINE SUL CAP</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugindication>BLOOD PRESSURE FLUCTUATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHLORIDE ^BIOTIKA^</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugindication>ELECTROLYTE SUBSTITUTION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
        <drugtreatmentduration>127</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHLORIDE ^BIOTIKA^</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE</medicinalproduct>
        <drugdosagetext>350 MG, IN OR</drugdosagetext>
        <drugindication>BLOOD PRESSURE FLUCTUATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE</medicinalproduct>
        <drugdosagetext>20 MG X 4 DOSES</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>420</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE</medicinalproduct>
        <drugdosagetext>40 MG, SINGLE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugdosagetext>.1 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugdosagetext>1/3 - 1/2 MAC (0.6% - 1.1%)</drugdosagetext>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
        <drugtreatmentduration>430</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCURONIUM</medicinalproduct>
        <drugdosagetext>50 MG, SINGLE</drugdosagetext>
        <drugindication>NEUROMUSCULAR BLOCKING THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
        <drugtreatmentduration>740</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VECURONIUM</medicinalproduct>
        <drugdosagetext>3 MG, QD</drugdosagetext>
        <drugindication>NEUROMUSCULAR BLOCKING THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE 0.9%</medicinalproduct>
        <drugdosagetext>250 ML X 4</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>420</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE 0.9%</medicinalproduct>
        <drugdosagetext>500 ML X 1</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGULAR INSULIN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>HYPERGLYCAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516562-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-373513</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030602</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030604</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOMYCIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030608</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOMYCIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030609</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030530</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030531</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAZUFLOXACIN MESILATE</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS PASIL</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030602</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516563-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ROCHE-387535</companynumb>
    <primarysource>
      <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>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TICLID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSAPREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTORC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516564-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-386801</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugdosagetext>FREQUENCY REPORTED AS WEEKLY.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIGAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040720</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516565-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040924</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ROCHE-381433</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>ON DAYS ONE THROUGH FOURTEEN OF A TWENTY-ONE DAY CYCLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040906</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS 243MG DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARINE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARINE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARINE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516566-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040910</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-380278</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516567-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ROCHE-385891</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030913</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030913</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRUFEN</medicinalproduct>
        <drugdosagetext>DOSE WAS REPORTED AS NECESSARY. DURATION OF USE REPORTED AS LONG TERM.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID</medicinalproduct>
        <drugdosagetext>DURATION REPORTED AS LONG TERM</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516568-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-386076</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C VIRUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C VIRUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516569-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-386811</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516570-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-387564</companynumb>
    <primarysource>
      <qualification>2</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>CELLCEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516571-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-ROCHE-387001</companynumb>
    <primarysource>
      <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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOLAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516572-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-386860</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA-2A</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516573-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041106581</companynumb>
    <primarysource>
      <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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516574-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>AT-JNJFOC-20041103993</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICRONOR</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516576-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040428</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12584926</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXTREX</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516577-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MA-BRISTOL-MYERS SQUIBB COMPANY-12772448</companynumb>
    <primarysource>
      <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>HAND AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCLOXACILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516579-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040422</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-12567194</companynumb>
    <primarysource>
      <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>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516580-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12606471</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXTREX</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516581-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12780672</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>DOSE VALUE:  15 TO 20 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPENTUM</medicinalproduct>
        <drugdosagetext>NUMBER OF DOSAGES:  3 TO 6 TIMES PER DAY.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516595-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030529</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0305USA02909</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIASTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA PAROXYSMAL NOCTURNAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS SUPERFICIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TREMOR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020517</drugenddate>
        <drugtreatmentduration>441</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011201</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL LA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516597-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041008024</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA MEGALOBLASTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS ATROPHIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERNICIOUS ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE PROMETHAZINE</medicinalproduct>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNITRAZEPAM</medicinalproduct>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUAZEPAM</medicinalproduct>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516598-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040801437</companynumb>
    <primarysource>
      <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>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516599-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00387</companynumb>
    <primarysource>
      <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>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCIATICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516600-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NSADSS2002023022</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.31</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOXIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020115</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516601-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20040405814</companynumb>
    <primarysource>
      <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>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOXID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>OSTEITIS</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516602-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0304USA00753</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>118</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACET JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAPULA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGGER FINGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000822</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000822</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000822</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVSIN PB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000822</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516604-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA04198</companynumb>
    <primarysource>
      <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>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516606-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0411FRA00094</companynumb>
    <primarysource>
      <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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516607-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0304USA00805</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLEX PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERNATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL PITTING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL POLYPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</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>4516609-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0410USA04164</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRACLID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRACLID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOY</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOY</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOY</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICHOLIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTCILLIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUMARIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRONGER NEO-MINOPHAGEN C</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEPATIC FUNCTION ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRONGER NEO-MINOPHAGEN C</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOSEGON</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PANCREATITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSCOPAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516610-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040308</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0403GBR00080</companynumb>
    <primarysource>
      <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>ALVEOLITIS FIBROSING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AORTIC ANEURYSM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>AORTIC ANEURYSM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516611-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0410GBR00144</companynumb>
    <primarysource>
      <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERIACTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516613-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-MERCK-0411NOR00052</companynumb>
    <primarysource>
      <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>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010310</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516614-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00550</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516615-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0411CAN00228</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516616-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105763</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATIONS, MIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516617-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041106417</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516618-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041106467</companynumb>
    <primarysource>
      <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>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516619-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041004688</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0422493</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>1 TABLET 2 TIMES A DAY AS NEEDED</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>1 TABLET 2 TIMES A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugdosagetext>1 TABLET AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZAPAM</medicinalproduct>
        <drugdosagetext>5 MG ONCE A DAY AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCREASE</medicinalproduct>
        <drugdosagetext>1 TABLET THREE TIMES A DAY AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516621-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041003767</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0403133</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516622-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041003359</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE BURNING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0416665</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0416665</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0416665</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516623-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00454</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE INVERSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE AND IRBESARTAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EQUILIN SODIUM SULFATE AND ESTRONE SODIUM SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516624-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03655</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516626-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00589</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040812</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516627-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00069</companynumb>
    <primarysource>
      <qualification>1</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516628-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00688</companynumb>
    <primarysource>
      <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>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516629-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA04137</companynumb>
    <primarysource>
      <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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516630-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03598</companynumb>
    <primarysource>
      <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>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[COMPOSITION UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516631-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-MERCK-0411CHE00040</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516632-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00460</companynumb>
    <primarysource>
      <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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE HEART DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516633-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA02319</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516634-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03574</companynumb>
    <primarysource>
      <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>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19790101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516635-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-MERCK-0411SWE00057</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516636-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03399</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516637-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA02310</companynumb>
    <primarysource>
      <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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516638-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03573</companynumb>
    <primarysource>
      <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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516640-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00533</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516643-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00145</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516644-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03577</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REGURGITATION OF FOOD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL MSD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516645-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03989</companynumb>
    <primarysource>
      <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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>1212</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VAS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516646-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04085</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031127</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516647-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03601</companynumb>
    <primarysource>
      <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>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROSTAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516648-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03877</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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516649-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03626</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516650-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03886</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516651-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03828</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516652-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03628</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516653-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00531</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516654-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA04211</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSMEGEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHABDOMYOSARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHABDOMYOSARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHABDOMYOSARCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516655-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0412CAN00001</companynumb>
    <primarysource>
      <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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516657-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04088</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SJOGREN'S SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516658-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04149</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516674-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20021105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12104337</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELAFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPRAM TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCUFLOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE + ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516677-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030331</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>12226866</companynumb>
    <primarysource>
      <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>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBOTHROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516678-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19991222</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>10217917</companynumb>
    <primarysource>
      <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>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBOTHROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN INJ</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990707</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FARMORUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990707</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990707</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991111</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugdosagetext>60 GY(GRAY) TO BREAST AND 45 GY ON LEFT  SUB-CLAVICLE</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990917</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516680-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12776076</companynumb>
    <primarysource>
      <qualification>3</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>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
        <drugtreatmentduration>108</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM FOLINATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
        <drugtreatmentduration>206</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPTOSAR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040925</drugenddate>
        <drugtreatmentduration>156</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040925</drugenddate>
        <drugtreatmentduration>208</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516682-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BRISTOL-MYERS SQUIBB COMPANY-12776415</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516683-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-12439535</companynumb>
    <primarysource>
      <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>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOPEG</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516722-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105907</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SJOGREN'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516723-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041001909</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516748-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-12726238</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMPULSIVE BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516749-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12777876</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GATIFLO TABS 100 MG</medicinalproduct>
        <drugdosagetext>TOOK 200 MG ON 08-NOV-2004, 400 MG ON 09-NOV-2004 + 10-NOV-2004</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOLONG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516750-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040914</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12702601</companynumb>
    <primarysource>
      <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>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCOMYST TABS 200 MG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040224</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELESTENE</medicinalproduct>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040224</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PNEUMOREL</medicinalproduct>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040220</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAXY</medicinalproduct>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040214</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRONCHODUAL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEO-MERCAZOLE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONO-TILDIEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516789-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP13537</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</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 BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESUSCITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRIDOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>30 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>180 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE</medicinalproduct>
        <drugdosagetext>2 G/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EURODIN</medicinalproduct>
        <drugdosagetext>1 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>8 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugdosagetext>24 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516791-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-240637</companynumb>
    <primarysource>
      <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>NOVOSEVEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>AORTIC ANEURYSM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516802-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CA15764</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugbatchnumb>0028000</drugbatchnumb>
        <drugdosagetext>160 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516804-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0497769B</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>6.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>1000MG AS REQUIRED</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516805-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040422</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0508712A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLEX PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIMPLE PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516806-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0508712B</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516807-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0518052A</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84.1</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUN SHOT WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516808-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040805</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0521064A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516809-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040816</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0522773A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCAPNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>75TAB SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NYQUIL</medicinalproduct>
        <drugdosagetext>1BT SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516812-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0529348A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <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>4516813-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0530913A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORGARD</medicinalproduct>
        <drugindication>POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516814-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0534644A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST CONCUSSION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516819-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0534646A</companynumb>
    <primarysource>
      <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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIPHYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUSOPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516820-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0534897A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD THINNER</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516821-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0534902A</companynumb>
    <primarysource>
      <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>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugdosagetext>25MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516822-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0534911A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF MUTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>80MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>80MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516823-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535030A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL ASSAULT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516824-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>041080059</companynumb>
    <primarysource>
      <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>PAROXETINE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516825-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535239A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL HAND MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516826-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NOT PROVIDED</companynumb>
    <primarysource>
      <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>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMIG</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516827-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030509</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0299376A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030426</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516828-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030515</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0299672A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTRIGLYCERIDAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugdosagetext>90MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOPROL</medicinalproduct>
        <drugdosagetext>.5UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC 325</medicinalproduct>
        <drugdosagetext>250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OROCAL D3</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEBRIDAT</medicinalproduct>
        <drugdosagetext>1UNIT THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIORFAN</medicinalproduct>
        <drugdosagetext>1UNIT THREE TIMES PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPASFON LYOC</medicinalproduct>
        <drugdosagetext>1UNIT FOUR TIMES PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL</medicinalproduct>
        <drugdosagetext>20MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugdosagetext>3MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERC</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516829-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0302187A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030514</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugdosagetext>200MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENTRICULAR EXTRASYSTOLES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>5MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPANOR</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516830-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0303532A</companynumb>
    <primarysource>
      <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>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030625</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLECAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMAREL</medicinalproduct>
        <drugdosagetext>3MG PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516832-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0304031A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030627</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>2PUFF AS REQUIRED</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030609</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516833-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031007</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0311029A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <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>LAMOTRIGINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>5MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>10MGS THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516834-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0323664A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugdosagetext>8MG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031114</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516835-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040722</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0340350A</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
        <drugdosagetext>2500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugdosagetext>.2MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INADEQUATE CONTROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
        <drugtreatmentduration>245</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516836-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0341022A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040725</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSFESTROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEMODIALYSIS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516837-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-GLAXOSMITHKLINE-B0344322A</companynumb>
    <primarysource>
      <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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040813</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>200MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugdosagetext>400MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>75MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516838-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GLAXOSMITHKLINE-B0350118A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOBACCO ABUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRICANYL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugdosagetext>1G PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEQUAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTELIN (VITAMIN D2)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VAGIFEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516839-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EE-GLAXOSMITHKLINE-B0357635A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>6.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZINACEF</medicinalproduct>
        <drugdosagetext>175MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516840-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0357671A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINI-SINTROM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516841-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0357766A</companynumb>
    <primarysource>
      <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>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040727</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugdosagetext>1250MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020812</drugenddate>
        <drugtreatmentduration>138</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugdosagetext>40MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040727</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021209</drugenddate>
        <drugtreatmentduration>257</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>3UNIT TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTRIVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516842-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GLAXOSMITHKLINE-B0357783A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPTODIN</medicinalproduct>
        <drugdosagetext>100MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516843-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0357863A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516844-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0357908A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>10</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
        <drugtreatmentduration>784</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75NG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPRAVENTRICULAR TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPRAVENTRICULAR TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PNEUMOVAX II</medicinalproduct>
        <drugdosagetext>.5ML SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516845-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0357909A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULPHATE</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>60MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORIDE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516847-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0357910A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516848-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0357911A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORAMBUCIL</medicinalproduct>
        <drugdosagetext>2MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040710</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIGAM</medicinalproduct>
        <drugdosagetext>30G MONTHLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
        <drugdosagetext>2DROP TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516849-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0357913A</companynumb>
    <primarysource>
      <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>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>850MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>6.75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART VALVE REPLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugbatchnumb>~</drugbatchnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516850-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M24750</companynumb>
    <primarysource>
      <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>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARECOXIB SODIUM</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREOPERATIVE CARE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516851-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0357949A</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR SULPHATE</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>6CAP PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030620</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516852-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0358383A</companynumb>
    <primarysource>
      <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>ZEFIX</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516853-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GLAXOSMITHKLINE-B0358422A</companynumb>
    <primarysource>
      <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516854-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0358509A</companynumb>
    <primarysource>
      <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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516855-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0358585A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTERIAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>1G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030218</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030218</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030216</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>.4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030218</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOCET</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030218</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDYFERON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADANCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODOPAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLO 3</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANAKAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSILANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACUTE PULMONARY OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACUTE PULMONARY OEDEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516856-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0358641A</companynumb>
    <primarysource>
      <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>BRONCHOPULMONARY ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>200MCG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516857-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GLAXOSMITHKLINE-B0358654A</companynumb>
    <primarysource>
      <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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516859-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GLAXOSMITHKLINE-B0358660A</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN TRIHYDRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516860-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GLAXOSMITHKLINE-B0358673A</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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>1TAB THREE TIMES PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>250MCG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>5MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>100MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAMCOLIT</medicinalproduct>
        <drugdosagetext>1200MG PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516861-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0358698A</companynumb>
    <primarysource>
      <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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>900MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030520</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516862-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0358724A</companynumb>
    <primarysource>
      <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>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMIGRANE</medicinalproduct>
        <drugdosagetext>50MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugdosagetext>1UD SIX TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPRONIZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516863-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0045220A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUKERAN</medicinalproduct>
        <drugdosagetext>2MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>1MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040316</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>900MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040316</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040412</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENIMMUN</medicinalproduct>
        <drugdosagetext>10MG EVERY TWO WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040412</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENIMMUN</medicinalproduct>
        <drugdosagetext>60G SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040412</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>20MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516864-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0045356A</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516866-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03425</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY KIDNEY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARLODEL</medicinalproduct>
        <drugdosagetext>5 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODOPAR</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516887-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040504</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12579843</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVA ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugdosagetext>75 MCG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516892-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12746673</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RICKETS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX EC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugdosagetext>THERAPY WAS INITIATED IN 1999 AT 400 MG AND DOSAGE WAS INCREASED TO 600 MG IN 2001.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516893-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-BRISTOL-MYERS SQUIBB COMPANY-12752416</companynumb>
    <primarysource>
      <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>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOVONEX</medicinalproduct>
        <drugdosagetext>^WIDE SPREAD APPLICATION^</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516954-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12773628</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MORBILLIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASTEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>DOSAGE FORM = UNIT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIMACTANE</medicinalproduct>
        <drugdosagetext>DOSAGE FORM = UNIT CAPSULES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIPARINE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLTRAMYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENITEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4516956-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12776019</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROVEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EURELIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030615</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPANTHYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030615</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPRAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030615</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517018-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BR15790</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM REPOLARISATION ABNORMALITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugdosagetext>10 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugdosagetext>400 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517067-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US11465</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ELECTROLYTES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BOWEL SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC PSEUDO-OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL MOTILITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION PSEUDOMONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALABSORPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>INTESTINAL HYPOMOTILITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>2 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
        <drugtreatmentduration>60480</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517075-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0281415-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517076-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0281255-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</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>DOXEPIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517078-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0281514-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE SEPARATION OF PLACENTA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
        <drugtreatmentduration>154</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
        <drugtreatmentduration>154</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517079-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0281515-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <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>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517082-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-03P-163-0244708-00</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>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031207</drugenddate>
        <drugtreatmentduration>108</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAQUINAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031207</drugenddate>
        <drugtreatmentduration>108</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</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>BUPROPION HYDROCHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLOPATADINE HYDROCHLORIDE</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>OXYCODONE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517083-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-ABBOTT-04P-007-0264231-01</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>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPRANAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRIMETAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
        <drugtreatmentduration>213</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFADIAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
        <drugtreatmentduration>213</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
        <drugtreatmentduration>213</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRUM</medicinalproduct>
        <drugdosagetext>7.5/300 MG</drugdosagetext>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
        <drugtreatmentduration>55</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517084-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0281753-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION SUICIDAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO FILM-COATED TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ISCHAEMIC STROKE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517085-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US100899</companynumb>
    <primarysource>
      <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>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517086-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US100901</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517087-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US100896</companynumb>
    <primarysource>
      <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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517090-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030722</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-03P-163-0225455-01</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS CRYPTOSPORIDIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIV DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030903</drugenddate>
        <drugtreatmentduration>75</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPRANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030903</drugenddate>
        <drugtreatmentduration>75</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE W/LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030903</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517091-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031006</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-03P-163-0235971-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACQUIRED IMMUNODEFICIENCY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030927</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPRANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>KAPOSI'S SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030929</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030929</drugenddate>
        <drugtreatmentduration>187</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030929</drugenddate>
        <drugtreatmentduration>205</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HAEMOLYTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030929</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</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>MULTI-VITAMINS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</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>IMMUNE GLOBULIN INTRAVENOUS (HUMAN)</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517092-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030919</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-03P-163-0234177-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD PH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KAPOSI'S SARCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SARCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030905</drugenddate>
        <drugtreatmentduration>107</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPRANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030905</drugenddate>
        <drugtreatmentduration>107</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>EVERY OTHER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOKALAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>EVERY OTHER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VARICONAZONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASPERGILLOSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030905</drugenddate>
        <drugtreatmentduration>107</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBACTERIAL PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030905</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517093-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20021220</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-02P-163-0206730-01</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEYNE-STOKES RESPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA ACIDOTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPRANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021213</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPRANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021226</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021213</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CELLULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021129</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021226</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021226</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021226</drugenddate>
        <drugtreatmentduration>73</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYMETHOLONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021226</drugenddate>
        <drugtreatmentduration>780</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021226</drugenddate>
        <drugtreatmentduration>73</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021226</drugenddate>
        <drugtreatmentduration>553</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021226</drugenddate>
        <drugtreatmentduration>262</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXFERRUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021226</drugenddate>
        <drugtreatmentduration>671</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021226</drugenddate>
        <drugtreatmentduration>114</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021226</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILGRASTIM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021226</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYSACCHARIDE-IRON COMPLEX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021226</drugenddate>
        <drugtreatmentduration>840</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021213</drugenddate>
        <drugtreatmentduration>191</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517094-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040903</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ABBOTT-04P-008-0272605-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS ENTEROCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS FOCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFABUTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBACTERIAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSTANON</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BLOOD TESTOSTERONE DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>KAPOSI'S SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030821</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANULOCYTE COLONY STIMULATING FACTOR</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NEUTROPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENFUVITIDE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010516</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517096-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ABBOTT-04P-083-0281718-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>538</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPRANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>538</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>246</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>250</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>538</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>250</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>706</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM FOLINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517097-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-ABBOTT-04P-153-0281345-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERAL SYMPTOM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA FRUIT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISACODYL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOTEROL HYDROBROMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBOFLAVIN TAB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517098-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0281573-00</companynumb>
    <primarysource></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>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOSOMATIC DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517099-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0281454-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.278</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATOMYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRODUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517100-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040823</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0271232-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</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>AMLODIPINE BESYLATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOMETASONE FUROATE</medicinalproduct>
        <drugindication>RHINORRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517101-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-04P-087-0281439-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASOLAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPRAVENTRICULAR TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040326</drugenddate>
        <drugtreatmentduration>107</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASOLAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031223</drugenddate>
        <drugtreatmentduration>107</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031209</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517116-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-US099399</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC LYMPHOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517167-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03836</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517169-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA04049</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041003</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENIDIPINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXCHLORPHENIRAMINE MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517170-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03672</companynumb>
    <primarysource>
      <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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517171-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03581</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517172-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0411AUS00227</companynumb>
    <primarysource>
      <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>DEMENTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GALANTAMINE HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517173-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA04202</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517174-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0411USA04138</companynumb>
    <primarysource>
      <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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODOPAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517175-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA04050</companynumb>
    <primarysource>
      <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 ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACARODERMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517176-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA00249</companynumb>
    <primarysource>
      <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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517177-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0311USA02557</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENOPAUSAL SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL DRYNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSMENORRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001125</drugenddate>
        <drugtreatmentduration>257</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001125</drugenddate>
        <drugtreatmentduration>257</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MITRAL VALVE PROLAPSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NERVOUSNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001125</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517178-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00031</companynumb>
    <primarysource>
      <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>CEREBRAL ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC DISPLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLPERISONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUPIRTINE MALEATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517179-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00697</companynumb>
    <primarysource>
      <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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHIPLASH INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517181-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20010319</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-01032321</companynumb>
    <primarysource>
      <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</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRODIURIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517182-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0402USA00066</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTION TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011211</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517184-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0410GBR00183</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PEMPHIGUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517185-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0411FRA00086</companynumb>
    <primarysource>
      <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>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUINDIONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE AND FORMOTEROL FUMARATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE SODIUM METASULFOBENZOATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517186-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040924</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0410GBR00028</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030317</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030317</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030315</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030315</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030315</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517187-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0411CAN00217</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517188-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041003</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0410CAN00067</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517189-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020514</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0205USA01796</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>109</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERUMEN IMPACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABILE HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABYRINTHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011019</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011019</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517198-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00530</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517199-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00107</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY ATHEROSCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOLSIDOMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY ATHEROSCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000921</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517200-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0411AUS00243</companynumb>
    <primarysource>
      <qualification>5</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>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517202-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041008</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA01495</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517203-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03378</companynumb>
    <primarysource>
      <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517204-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA01010</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>374</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>374</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHIC PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040114</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHIC PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040126</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040225</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517205-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00529</companynumb>
    <primarysource>
      <qualification>4</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517207-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040917</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP12445</companynumb>
    <primarysource>
      <qualification>3</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL STROMAL TUMOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517208-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03290</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>KAPOSI'S SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG DAILY</drugdosagetext>
        <drugadministrationroute>046</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugdosagetext>1 G DAILY</drugdosagetext>
        <drugindication>ERYSIPELAS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>250 MG DAILY</drugdosagetext>
        <drugindication>DERMATOPHYTOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOTELON</medicinalproduct>
        <drugdosagetext>2 DF DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENOUS INSUFFICIENCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517209-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040907</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE03152</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE DELAYED UNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>100 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517210-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA02285</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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASOCONSTRICTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMADEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517211-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00519</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040822</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517213-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517214-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0411GBR00275</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517215-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03599</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4517216-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00740</companynumb>
    <primarysource>
      <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>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPONDYLOARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517218-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-MERCK-0411SWE00040</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517219-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA02142</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900401</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOZOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517220-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03579</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4517221-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA01728</companynumb>
    <primarysource>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040803</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
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    <safetyreportid>4517223-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA01627</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
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        <drugenddate>20040930</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>4517224-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
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    <receiptdate>20041111</receiptdate>
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    <primarysource>
      <qualification>1</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>ATHEROSCLEROSIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIASTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000622</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
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        <drugstartdate>20000717</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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    <safetyreportid>4517226-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA01630</companynumb>
    <primarysource>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517227-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03732</companynumb>
    <primarysource>
      <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 DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517229-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03633</companynumb>
    <primarysource>
      <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>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517230-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00043</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517231-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03700</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL FAECES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGRAPHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517234-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03670</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517237-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-0411ESP00031</companynumb>
    <primarysource>
      <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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>246</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </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>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517239-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MY-MERCK-0411MYS00008</companynumb>
    <primarysource>
      <qualification>1</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517240-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-MERCK-0411SWE00041</companynumb>
    <primarysource>
      <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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA AND LEVODOPA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETILEFRINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE DIHYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENSERAZIDE HYDROCHLORIDE AND LEVODOPA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517241-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03839</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010701</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517243-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03761</companynumb>
    <primarysource>
      <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>CAROTID ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517244-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03734</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517245-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4517246-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PR-MERCK-0411USA03845</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLANK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
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        <drugenddate>20040801</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4517247-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
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    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
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      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>4517248-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
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    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
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    <primarysource>
      <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>1</patientsex>
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        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
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      <drug>
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        <medicinalproduct>VIOXX</medicinalproduct>
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        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031007</drugstartdate>
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  <safetyreport>
    <safetyreportid>4517250-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
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    <receiptdate>20041123</receiptdate>
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    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
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        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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    <safetyreportid>4517251-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
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    <receiptdateformat>102</receiptdateformat>
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    <primarysource>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
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        <drugindication>ARTHRITIS</drugindication>
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        <drugenddate>20030101</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
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        <drugenddate>20040901</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>4517252-X</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
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      <drug>
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        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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  <safetyreport>
    <safetyreportid>4517253-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <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>CARDIAC DISORDER</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
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        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
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    <safetyreportid>4517254-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
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    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
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    <primarysource>
      <qualification>3</qualification>
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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>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PARATHYROID TUMOUR BENIGN</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
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        <drugenddate>20031201</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
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  <safetyreport>
    <safetyreportid>4517255-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
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      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
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        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
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      <drug>
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        <medicinalproduct>COUMADIN</medicinalproduct>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
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  <safetyreport>
    <safetyreportid>4517257-9</safetyreportid>
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      <qualification>5</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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      <patientsex>1</patientsex>
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        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
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      <drug>
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        <medicinalproduct>LISINOPRIL</medicinalproduct>
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  <safetyreport>
    <safetyreportid>4517258-0</safetyreportid>
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    <sender>
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    <receiver></receiver>
    <patient>
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    <receiver></receiver>
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    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04147</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517262-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04111</companynumb>
    <primarysource>
      <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>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517265-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE316409NOV04</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG UNSPECIFED FREQUENCY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENZYMES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACECLOFENAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517267-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA02990</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517272-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA00396</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK LEFT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN ES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517288-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04169</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517374-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-JNJFOC-20041106158</companynumb>
    <primarysource>
      <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>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>4 INFUSIONS.  2 HOUR INFUSION.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>30-40MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517375-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041106376</companynumb>
    <primarysource>
      <qualification>2</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>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517376-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20040707528</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBOTHROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA CYTOMEGALOVIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA PRIMARY ATYPICAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS OCCLUSION</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>AZATHIOPRINE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517377-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20040503859</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMYOTROPHIC LATERAL SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISTAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517378-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041000757</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517427-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004NL15792</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>.5 MG, TID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517428-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE03944</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517526-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030327</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ABBOTT-03P-144-0214776-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030321</drugenddate>
        <drugtreatmentduration>270</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPRANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030321</drugenddate>
        <drugtreatmentduration>270</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020920</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517529-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040913</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0282000-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </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>NAPROXEN</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>4517531-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-04P-087-0281481-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZON CAPSULE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERRAPEPTASE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517532-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0281711-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
        <drugtreatmentduration>87</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPRANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
        <drugtreatmentduration>87</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
        <drugtreatmentduration>87</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
        <drugtreatmentduration>87</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
        <drugtreatmentduration>87</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517534-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-04P-013-0281281-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VACCINATION COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLU VACCINATION</medicinalproduct>
        <drugindication>INFLUENZA IMMUNISATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517535-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0281366-00</companynumb>
    <primarysource></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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</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>
      </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>CLOPIDOGREL BISULFATE</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>NOVOLIN INSULIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517536-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-04P-087-0281479-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZON CAPSULE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZON CAPSULE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRUCTLACT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METAMIZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRUFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020929</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUSCODE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METAMIZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517538-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ABBOTT-04P-008-0281694-00</companynumb>
    <primarysource></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>ENCEPHALITIS</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>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE PHOSPHATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517539-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0281232-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC DIABETES INSIPIDUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED ANTICONVULSANTS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517540-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0281526-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040727</drugenddate>
        <drugtreatmentduration>715</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020812</drugenddate>
        <drugtreatmentduration>136</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040727</drugenddate>
        <drugtreatmentduration>715</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021209</drugenddate>
        <drugtreatmentduration>256</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE W/LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTRICITABINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIDOFOVIR</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTINOINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517541-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040808</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0269908-00</companynumb>
    <primarysource></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>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMDAX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>12 UG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIAC FAILURE ACUTE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMDAX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>0.1UG/KG/MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMDAX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>0.2 UG/KG/MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517543-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ABBOTT-04P-114-0281537-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030805</drugenddate>
        <drugtreatmentduration>581</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030930</drugenddate>
        <drugtreatmentduration>581</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031024</drugenddate>
        <drugtreatmentduration>581</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>12.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020321</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517575-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004IT15653</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE STIMULATION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETICULOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LETROZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>175 MG/M2</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517576-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-240644</companynumb>
    <primarysource></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>VAGIFEM</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMHRT</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLIMARA ^BERLEX^</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517578-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040420</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BRISTOL-MYERS SQUIBB COMPANY-12565933</companynumb>
    <primarysource>
      <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>ACUTE VESTIBULAR SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABATACEPT</medicinalproduct>
        <drugdosagetext>NO. OF COURSES: 13</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORFLEX</medicinalproduct>
        <drugdosagetext>DOSAGE FORM + TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517579-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12774485</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>VINBLASTINE SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040911</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTRIVA</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLEOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETICENE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040911</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517580-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-11714169</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSULIN RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPODYSTROPHY ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugdosagetext>ONGOING DURING THE FIRST THREE MONTHS OF PREGNANCY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugdosagetext>THERAPY ONGOING AT CONCEPTION.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugdosagetext>THERAPY DURING GESTATION.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugdosagetext>THERAPY FROM 3 MONTHS GESTATION.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugdosagetext>ONGOING AT CONCEPTION</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>DOSAGE FORM = TABLET.  THERAPY DURING GESTATION.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
        <drugdosagetext>THERAPY DURING GESTATION. ^960 MG DAILY^</drugdosagetext>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugdosagetext>DOSAGE FORM = TABLET.  THERAPY DURING GESTATION.</drugdosagetext>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROSE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517581-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-11723939</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD INSULIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugdosagetext>ONGOING THE FIRST 3 MONTHS OF PREGNANCY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugdosagetext>ONGOING FOR THE FIRST THREE MONTHS OF PREGNANCY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugdosagetext>FROM 2 MONTHS GESTATION</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugdosagetext>EXPOSURE BEGAN AT CONCEPTION.</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugdosagetext>ONGOING FROM MONTH 3 FOR THE REMAINER OF THE PREGNANCY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>EXPOSURE DURING GESTATION.  DOSAGE FORM = TABLET.</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
        <drugdosagetext>EXPOSURE DURING GESTATION. ^960 MG DAILY^</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugdosagetext>EXPOSURE DURING GESTATION.  DOSAGE FORM = TABLET.</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROSE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517582-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-240643</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIVELLA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517585-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-240646</companynumb>
    <primarysource></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>ACTIVELLA</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517591-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040303</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410751JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <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>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL VOLUME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN PLATELET VOLUME DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED CELL DISTRIBUTION WIDTH INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517592-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410212JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517612-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-240309</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UTERINE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE POLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VAGIFEM</medicinalproduct>
        <drugbatchnumb>PE70096</drugbatchnumb>
        <drugdosagetext>2 TAB, BIW</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>VAGINITIS ATROPHIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VAGIFEM</medicinalproduct>
        <drugbatchnumb>PE70096</drugbatchnumb>
        <drugdosagetext>2 TAB, BIW</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM                                 /N/A/</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVATAN</medicinalproduct>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>COAGULOPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517628-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15796</companynumb>
    <primarysource>
      <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>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NEOPLASM EXCISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISUMIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOSMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEREKINON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517629-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03327</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLTRAMYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>PHARYNGITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPANTHYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040510</drugenddate>
        <drugtreatmentduration>90720</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040617</drugenddate>
        <drugtreatmentduration>130</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>100 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040721</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>200 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040728</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>300 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040805</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFU K</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OROCAL D(3)</medicinalproduct>
        <drugdosagetext>2 DF DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517636-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040306577</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE IMMEASURABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0316771</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0316771</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN ES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN ES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYCYCLOMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517637-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20041106345</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517638-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20041106350</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517639-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040900334</companynumb>
    <primarysource>
      <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>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517640-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041101653</companynumb>
    <primarysource>
      <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>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517641-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041106773</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FUSION ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORACET</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517653-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041200339</companynumb>
    <primarysource>
      <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>BETA 2 MICROGLOBULIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BETA-N-ACETYL-D-GLUCOSAMINIDASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517654-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20040700482</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugdosagetext>PULSE THERAPY 400MG/DAY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040616</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>NISOLDIPINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517655-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041104117</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>NO ADVERSE DRUG EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPULSID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040708</drugenddate>
        <drugtreatmentduration>387</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPULSID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040708</drugenddate>
        <drugtreatmentduration>387</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFF-K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORLAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517656-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041200186</companynumb>
    <primarysource>
      <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>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBATROL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517657-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041003910</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IATROGENIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBIN BLOOD INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugbatchnumb>04BS62G</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugbatchnumb>04BS62G</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugindication>PARKINSONISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFARLEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517658-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040906352</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>130.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517659-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040901777</companynumb>
    <primarysource>
      <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>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517660-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041008685</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIANSERIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517661-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041008684</companynumb>
    <primarysource>
      <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>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAPRIDE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517662-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041105943</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLEFT PALATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517663-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20041200053</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>NERVOUSNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENERGAN</medicinalproduct>
        <drugindication>NERVOUSNESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517664-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041102159</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMACET</medicinalproduct>
        <drugdosagetext>1 - 2 TABS QDS PRN</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
        <drugdosagetext>DOSE 10 - 20 MLS, OF MANY YEARS DURATION</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>OF MANY YEARS DURATION</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517665-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.8122</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25 MG + 50 MG VIOXX</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25 MG + 50 MG VIOXX</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517666-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50.8029</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>100 MGM BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANDROGENS INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517667-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040504167</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTMENOPAUSAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETHRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE POLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANY MEDICATIONS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517668-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20041106367</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517669-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</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>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugdosagetext>50 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517670-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.5338</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE 25MG AND 100MG IVAX</medicinalproduct>
        <drugdosagetext>P.O. TITRATION (STANDARD)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE ER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517671-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA HAEMOLYTIC AUTOIMMUNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN D DIMER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVEDO RETICULARIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugdosagetext>670 MG WEEKLY INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517672-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>125.1928</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>100 MG AM, 200 MG HS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>Z-PAK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517673-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004FR15592</companynumb>
    <primarysource>
      <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>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE INVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAFTIDROFURYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOSMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM/VITAMIN D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRIDERM TTS</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE</medicinalproduct>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
        <drugtreatmentduration>40320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>50MG/DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040704</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517674-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.4619</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>1 PER DAY</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040904</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517675-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>MALAISE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517676-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>1 X 200MG  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PLANTAR FASCIITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517677-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.977</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugdosagetext>1 Q WEEKEND</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517678-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200420812GDDC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDEX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517679-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040526</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200412119FR</companynumb>
    <primarysource>
      <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>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFINAH</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFATER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517680-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20010627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200114751US</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACIDOSIS HYPERCHLORAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KUSSMAUL RESPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>A207</drugbatchnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>DOSE: 10-15; DOSE UNIT: UNITS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM PHOSPHATES</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517681-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413475EU</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOLVON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELTACORTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517682-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421157GDDC</companynumb>
    <primarysource>
      <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>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFATER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIMOXAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517683-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419170US</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF MATERNAL EXPOSURE TO THERAPEUTIC DRUGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYHYDRAMNIOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>ASYMPTOMATIC GENE CARRIER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>FACTOR V LEIDEN MUTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517684-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419173US</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYHYDRAMNIOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>ASYMPTOMATIC GENE CARRIER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>FACTOR V LEIDEN MUTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517685-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421522GDDC</companynumb>
    <primarysource>
      <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>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALCOHOL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040821</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040821</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517686-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.8852</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>650 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>650 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>650 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>400 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040721</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517687-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.8852</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>650 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>650 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>650 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>400 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040721</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517688-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1000 MG/M2 IV = 1800 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1000 MG/M2 IV = 1800 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1000 MG/M2 IV = 1800 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1000 MG/M2 IV = 1800 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1000 MG/M2 IV = 1800 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1000 MG/M2 IV = 1800 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1000 MG/M2 IV = 1800 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANZEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-ENZYME 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MG N3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCREATIC ENZYMES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517689-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEPESID</medicinalproduct>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517690-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-NOVOPROD-240692</companynumb>
    <primarysource>
      <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>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTRAPID HM</medicinalproduct>
        <drugdosagetext>2 IU, QD</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTRAPHANE HM PENSET</medicinalproduct>
        <drugdosagetext>12 IU, QD</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517691-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>122.0176</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN 7MG (5+2) PO DAY</medicinalproduct>
        <drugdosagetext>(5+2) PO DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN 300 MG</medicinalproduct>
        <drugdosagetext>2 TABS PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517693-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419082US</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517694-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419085US</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 56 (3 WEEKS ON, 1 WEEK OFF)</drugdosagetext>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 0.25 (IV PUSH ONE HOUR PRIOR TO TAXOTERE)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 1 (ONE HOUR PRIOR TO TAXOTERE)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 8 (ONE HOUR PRIOR TO TAXOTERE)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID AC</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: PRN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517699-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12776688</companynumb>
    <primarysource>
      <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>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROVEL TABS 150 MG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVIAL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517700-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12773008</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXABEPILONE</medicinalproduct>
        <drugdosagetext>INITIAL DOSE. ADM ON DAYS 1, 8 AND 15, Q28 DAYS DURING CYLES 1-6. TOTAL DOSE ADM:66MG.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>INITIAL DOSE. ADM: ON DAYS 1, 8 + 15 Q28 DAYS DURING CYCLE 1-6. AUC 2 (TOTAL DOSE: 624 MG)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugdosagetext>4 MG/KG ADM DAY 1, WK 1 ONLY. 2MG/KG ADM DAY 1,8,15,22  TOTAL DOSE ADM: 300 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517701-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12773743</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIPLE VESSEL BYPASS GRAFT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517702-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NG-BRISTOL-MYERS SQUIBB COMPANY-12776894</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROPAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517703-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12776407</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROVEL</medicinalproduct>
        <drugdosagetext>DOSAGE NOT REPORTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FELDENE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040820</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NSAID</medicinalproduct>
        <drugdosagetext>RECEIVED 15 DAYS PRIOR TO EVENT</drugdosagetext>
        <drugindication>PAIN PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugindication>VERTIGO</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETASERC</medicinalproduct>
        <drugindication>VERTIGO</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANTALVIC</medicinalproduct>
        <drugdosagetext>6 CAPS/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>6 TABS/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517707-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BE13944</companynumb>
    <primarysource>
      <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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERURICAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugdosagetext>50 MG/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517708-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15843</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS CHRONIC ACTIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517709-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15851</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517710-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15854</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OBLITERATIVE BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRRADIATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517711-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15795</companynumb>
    <primarysource>
      <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>RESPIRATORY FUME INHALATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
        <drugdosagetext>600 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>25 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>1 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugdosagetext>15 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>150 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>53280</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>400 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517712-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03443</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROIDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517715-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004IT14871</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEBORRHOEIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DESQUAMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINEA VERSICOLOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLEP</medicinalproduct>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLEP</medicinalproduct>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GARDENALE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GARDENALE</medicinalproduct>
        <drugdosagetext>50 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GARDENALE</medicinalproduct>
        <drugdosagetext>25 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GARDENALE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETANUS GAMMA GLOBULIN</medicinalproduct>
        <drugdosagetext>500 UI/ML/ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517716-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004ES15814</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMAZINA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOLOTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENESTAN - SLOW RELEASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETRUSITOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURAZEPAM HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517717-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ABBOTT-04P-144-0280428-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTERAL NUTRITION</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517722-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2003FR00610</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUGULAR VEIN DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL REVASCULARISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERIOR VENA CAVAL OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR SHUNT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESERNIL-SANDOZ</medicinalproduct>
        <drugdosagetext>AT LEAST 1.65 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGIOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021029</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517723-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-PRA100032</companynumb>
    <primarysource>
      <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>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517729-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CN15730</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER FEMALE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517735-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93.441</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>500 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATITIS</drugindication>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517736-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>250</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517737-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040808</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517738-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.3899</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>12.5 MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517739-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.9676</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>PO Q AM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517740-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COAGULATION TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANGIOMAX</medicinalproduct>
        <drugbatchnumb>604510</drugbatchnumb>
        <drugdosagetext>BOLUS 12 ML DRIP @ 28 ML/HR</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517741-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.0396</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>1 PER DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517742-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15841</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </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>SANDOSTATIN</medicinalproduct>
        <drugdosagetext>300 UG/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GASTROINTESTINAL OBSTRUCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517743-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE DRUG EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANGIOMAX</medicinalproduct>
        <drugbatchnumb>604510</drugbatchnumb>
        <drugdosagetext>BOLUS 7.5 ML DRIP  Q 14CC/HR</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517749-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12664</companynumb>
    <primarysource></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>SANDOSTATIN LAR</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugindication>CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517751-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12665</companynumb>
    <primarysource></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>SANDOSTATIN LAR</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugindication>CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517770-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BRISTOL-MYERS SQUIBB COMPANY-12777900</companynumb>
    <primarysource>
      <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugbatchnumb>03C00601</drugbatchnumb>
        <drugdosagetext>TOTAL DOSE 882 MG IN 441 ML TO BE GIVEN OVER 120 MINUTES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517780-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040823</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-378252</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOPROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACUILIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040507</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517781-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-387347</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>12</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517783-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040223</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-359554</companynumb>
    <primarysource>
      <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 CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL TRACT INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011105</drugenddate>
        <drugtreatmentduration>102</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010722</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010726</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030504</drugenddate>
        <drugtreatmentduration>545</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020731</drugenddate>
        <drugtreatmentduration>414</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030702</drugenddate>
        <drugtreatmentduration>337</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020731</drugenddate>
        <drugtreatmentduration>414</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030702</drugenddate>
        <drugtreatmentduration>337</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030702</drugenddate>
        <drugtreatmentduration>740</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030702</drugenddate>
        <drugtreatmentduration>722</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030702</drugenddate>
        <drugtreatmentduration>740</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030702</drugenddate>
        <drugtreatmentduration>605</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030702</drugenddate>
        <drugtreatmentduration>629</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030514</drugenddate>
        <drugtreatmentduration>598</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGIZONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030514</drugenddate>
        <drugtreatmentduration>701</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030702</drugenddate>
        <drugtreatmentduration>626</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020919</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517784-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040226</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-360062</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>805</patientonsetageunit>
      <patientweight>2.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOSPADIAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040218</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517785-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-383692</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
        <drugtreatmentduration>106</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
        <drugtreatmentduration>107</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELTROXIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS GLUCONATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040712</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAVOL TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AXID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFATRIM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040718</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517786-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040804</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-376796</companynumb>
    <primarysource>
      <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>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR FOLLICLE TUMOUR BENIGN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTUSSUSCEPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE ADHESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCLOMETASONE DIPROPIONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE AND ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORABID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990204</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517787-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>165.5629</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>50 MG DAILY IN TABLET</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517788-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-384219</companynumb>
    <primarysource>
      <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>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALSE POSITIVE LABORATORY RESULT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NISORI-M</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORIAMIN</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS MORIAMIN (MIXED AMINO ACID PREPARATIONS FOR TOTAL PARENTERAL NUTRIT)</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C</medicinalproduct>
        <drugdosagetext>FORM: INJECTION</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>C-PARA</medicinalproduct>
        <drugdosagetext>FORM: INJECTION</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517789-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-387128</companynumb>
    <primarysource>
      <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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040309</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517790-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-387238</companynumb>
    <primarysource>
      <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>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517791-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-386374</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>ROUTE: INJECTION</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517792-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-387157</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugdosagetext>FORMULATION: INJECTABLE SOLUTION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040217</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS PULMICORT 0,50/2ML</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040214</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040214</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS SOLUPRED 20</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX 40</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517793-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-387337</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>805</patientonsetageunit>
      <patientweight>3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT TACHYPNOEA OF THE NEWBORN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040218</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517794-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>1 TABLET / DAY / ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT E</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517795-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-387326</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517796-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-387563</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517797-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-387340</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GANGLION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUVENILE ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517798-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY BLADDER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOSITUMOMAB</medicinalproduct>
        <drugdosagetext>450 MG IV OVER 60^</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL SMALL LYMPHOCYTIC LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOSITUMOMAB</medicinalproduct>
        <drugdosagetext>450 MG IV OVER 60^</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXXAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517799-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-12774436</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMADESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>C2: 03-SEP-04; C3: 17-SEP-2004</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040820</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517800-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIFOSTINE</medicinalproduct>
        <drugdosagetext>500MG-5 DAYS WK</drugdosagetext>
        <drugindication>PLASMACYTOMA</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517801-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12776092</companynumb>
    <primarysource>
      <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>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROVEL TABS 300 MG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPANTHYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517802-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>UVEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>25MG INCREASED WEEKLY</drugdosagetext>
        <drugindication>RADICULOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517803-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03695</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE MB INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DANAPAROID SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIMETHYL SULFONE AND GLUCOSAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517804-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517805-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA04187</companynumb>
    <primarysource>
      <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>INFUSION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLITA T-3</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOLAMIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517806-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03970</companynumb>
    <primarysource>
      <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>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517807-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04006</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517808-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0411AUS00185</companynumb>
    <primarysource>
      <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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOTHIEPIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19900114</drugenddate>
        <drugtreatmentduration>252</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517809-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0411GBR00141</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517810-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04252</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517811-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03815</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517812-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.8122</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517813-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46.7205</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHYOL</medicinalproduct>
        <drugdosagetext>500 MG, WED/THURS SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHYOL</medicinalproduct>
        <drugdosagetext>500 MG, WED/THURS SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHYOL</medicinalproduct>
        <drugdosagetext>500 MG, WED/THURS SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHYOL</medicinalproduct>
        <drugdosagetext>500 MG, WED/THURS SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517814-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20021014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0210USA01487</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY RESTENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SICK SINUS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000913</drugenddate>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000913</drugenddate>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517815-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0301USA01540</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA INFECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURED COCCYX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORRECTOL (DOCUSATE SODIUM (+) PHENOLPHTHALEIN)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517820-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0304USA00760</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPTY SELLA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABYRINTHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CYST BENIGN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517821-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0411FRA00102</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517823-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030929</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0310USA00099</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGE INDETERMINATE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC BRUIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDIX DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS ATROPHIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMOCYSTINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY SMALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METAPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517824-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00096</companynumb>
    <primarysource>
      <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>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517825-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0311USA02538</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL DRYNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010707</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELAFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517826-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031218</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0312USA02102</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>132</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIANOPIA HOMONYMOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MONARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030120</drugenddate>
        <drugtreatmentduration>573</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMADEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030120</drugenddate>
        <drugtreatmentduration>615</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030120</drugenddate>
        <drugtreatmentduration>615</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOZOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030120</drugenddate>
        <drugtreatmentduration>615</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROITIN SULFATE SODIUM AND GLUCOSAMINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517828-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030806</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0308USA00752</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JOINT INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020108</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020108</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>JOINT INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010808</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517830-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030829</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0309USA00024</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIGAMENT INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TENDONITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517831-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030929</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0310USA00134</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>136</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAUSTIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOARSENESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT CREPITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABYRINTHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517835-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0302USA00118</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPARATHYROIDISM SECONDARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENIERE'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEASONAL ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SILENT MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010907</drugenddate>
        <drugtreatmentduration>422</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020822</drugenddate>
        <drugtreatmentduration>406</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROITIN SULFATE SODIUM AND GLUCOSAMINE HYDROCHLORIDE AND MANGANESE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517837-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA00345</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040910</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040910</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORCET-HD</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELDENE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517838-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041002</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-MERCK-0410BRA00083</companynumb>
    <primarysource>
      <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>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517839-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041002</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-MERCK-0410BRA00089</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040622</drugenddate>
        <drugtreatmentduration>1001</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517840-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00605</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CAUDA EQUINA SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010704</drugenddate>
        <drugtreatmentduration>504</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MUSCLE CRAMP</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010813</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517841-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA02430</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517842-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA01160</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERAL SYMPTOM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517843-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA02600</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA PAROXYSMAL NOCTURNAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOE DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SURFAK</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517844-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA01776</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517846-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0410GBR00210</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYMYALGIA RHEUMATICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE AND CHOLECALCIFEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEFLAZACORT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517847-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041106368</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COR PULMONALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>1.3MG/M2, INTRAVENOUS, DAYS 1,4, 8 AND 11, EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INHALER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517848-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041200001</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>25</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE DRUG EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTRA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517850-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041004401</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0410560;0307386</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517851-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041106741</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>111.59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0422497;0418272</drugbatchnumb>
        <drugdosagetext>TWO 100 UG/HR PATCHES, AND ONE 50 UG/HR PATCH</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0422497;0418272</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517852-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040904576</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EHLERS-DANLOS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517853-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NSADSS2003015655</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.86</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANALGESIC DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOAMING AT MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NARCOTIC INTOXICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNORING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517854-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12435822</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANATENSOL</medicinalproduct>
        <drugdosagetext>IN OCTOBER 2003, DOSE CHANGED TO 0.5 MG DAILY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517855-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12444006</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANATENSOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZTROPINE MESYLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517856-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12454963</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIXIN</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517857-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12502522</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HALLUCINATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517858-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040405</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12551347</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517859-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040521</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12593299</companynumb>
    <primarysource>
      <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>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIXIN</medicinalproduct>
        <drugdosagetext>ROUTE: ^SHOT^</drugdosagetext>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517860-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040608</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12608766</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIXIN</medicinalproduct>
        <drugdosagetext>THERAPY TO DATE:  SEPT/OCT-2003.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19730101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517861-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12617544</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIXIN</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517862-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12641064</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN ES TABS</medicinalproduct>
        <drugbatchnumb>402582</drugbatchnumb>
        <drugdosagetext>DOSE TAKEN:  3 TABLETS AT A TIME, EVERY FEW HOURS , EVERY DAY, FOR A LONG TIME.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN ES TABS</medicinalproduct>
        <drugbatchnumb>402582</drugbatchnumb>
        <drugdosagetext>DOSE TAKEN:  3 TABLETS AT A TIME, EVERY FEW HOURS , EVERY DAY, FOR A LONG TIME.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIXIN</medicinalproduct>
        <drugdosagetext>INJECTION</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEROCCA PLUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>25MG AT BEDTIME</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517863-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12696209</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517864-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12723136</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517865-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12725156</companynumb>
    <primarysource>
      <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>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIXIN</medicinalproduct>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517866-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12729257</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIXIN</medicinalproduct>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517867-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0411AUS00241</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ROAD TRAFFIC ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517868-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SI-MERCK-0411HUN00011</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040427</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517869-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-MERCK-0411SWE00059</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517870-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.6683</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRIDOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>250 MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517871-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0411CAN00236</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PARATHYROID HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFRACTORY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETICULOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
        <drugtreatmentduration>907</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOETIN ALFA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NEPHROGENIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040426</drugenddate>
        <drugtreatmentduration>957</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NEPHROGENIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
        <drugtreatmentduration>2074</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE AND SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517872-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-MERCK-0411SWE00060</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517873-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03731</companynumb>
    <primarysource>
      <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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517874-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0411AUS00242</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517875-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0411AUS00248</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
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        <drugindication>ARTHRITIS</drugindication>
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        <drugstartdate>20030101</drugstartdate>
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        <drugenddate>20040501</drugenddate>
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  <safetyreport>
    <safetyreportid>4517876-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
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      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>750 MG BID</drugdosagetext>
        <drugindication>HEART TRANSPLANT</drugindication>
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        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>4517878-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>75.2971</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>.25 MG TID</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>.25 MG TID</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517879-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
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        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>4517880-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00202</companynumb>
    <primarysource>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>95</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE CALCIFICATION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUMBAR SPINAL STENOSIS</drugindication>
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        <drugstartdate>20021024</drugstartdate>
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        <drugenddate>20040901</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</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>DIGITEK</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4517881-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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    </patient>
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  <safetyreport>
    <safetyreportid>4517882-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03730</companynumb>
    <primarysource>
      <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>DRUG INTERACTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
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  <safetyreport>
    <safetyreportid>4517883-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03716</companynumb>
    <primarysource>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE DISEASE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MITRAL VALVE DISEASE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>4517884-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <qualification>2</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
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        <drugindication>DEMENTIA</drugindication>
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  <safetyreport>
    <safetyreportid>4517885-0</safetyreportid>
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    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <receivedateformat>102</receivedateformat>
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    <receiptdate>20041103</receiptdate>
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    <companynumb>CA-MERCK-0411CAN00056</companynumb>
    <primarysource>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
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        <drugstartdate>20000101</drugstartdate>
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  <safetyreport>
    <safetyreportid>4517886-2</safetyreportid>
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    <transmissiondate>20050328</transmissiondate>
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    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
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    <primarysource>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
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      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugindication>BURSITIS</drugindication>
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    <safetyreportid>4517887-4</safetyreportid>
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      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>CHILLS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>SCOTOMA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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      <qualification>1</qualification>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
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        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
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        <reactionmeddrapt>APHASIA</reactionmeddrapt>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03353</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517890-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00710</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASILAR ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517891-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00178</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>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517892-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00212</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RADICULITIS CERVICAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYNACIRC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RADICULITIS CERVICAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RADICULITIS CERVICAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RADICULITIS CERVICAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991010</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517893-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00625</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517894-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03832</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS INFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL-BC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517895-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA02211</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517896-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04107</companynumb>
    <primarysource>
      <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>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517897-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03895</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517898-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03811</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>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
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        <drugindication>ARTHRITIS</drugindication>
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        <drugstartdate>20000101</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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        <drugenddate>20040901</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4517899-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4517900-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
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      <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>115.4404</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugdosagetext>2 BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040520</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugdosagetext>2 BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESKALITH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CA LI CO3</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTIN XL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHERGINE</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4517901-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
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      <qualification>5</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>4517902-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03773</companynumb>
    <primarysource>
      <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>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
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  <safetyreport>
    <safetyreportid>4517904-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
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    <primarysource>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>1 PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
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  <safetyreport>
    <safetyreportid>4517910-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>200 MG 2 BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
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  <safetyreport>
    <safetyreportid>4517912-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <qualification>3</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugdosagetext>DOSE REDUCED FROM 400 TO 300 MG ON 22-OCT-2004 PRIOR TO EVENTS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
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        <drugenddate>20041101</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
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  <safetyreport>
    <safetyreportid>4517913-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
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      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET CR</medicinalproduct>
        <drugdosagetext>PO BID</drugdosagetext>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELDEPRYL</medicinalproduct>
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        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
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        <drugstartdate>19930101</drugstartdate>
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  <safetyreport>
    <safetyreportid>4517914-4</safetyreportid>
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    <receivedateformat>102</receivedateformat>
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    <primarysource>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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  <safetyreport>
    <safetyreportid>4517915-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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      <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>AORTIC OCCLUSION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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        <drugstartdate>19990101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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    <safetyreportid>4517917-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedateformat>102</receivedateformat>
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      <qualification>5</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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        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugstartdateformat>102</drugstartdateformat>
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  <safetyreport>
    <safetyreportid>4517918-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
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        <drugcharacterization>1</drugcharacterization>
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        <drugcharacterization>1</drugcharacterization>
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        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIRARUBICIN</medicinalproduct>
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        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
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    <safetyreportid>4517919-3</safetyreportid>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
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      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROVEL TABS 150 MG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIASCLEDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517921-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03894</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517922-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03954</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517923-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-12734570</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOSMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517925-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12776944</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517926-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.9572</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTAZOCINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517927-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040824</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12681128</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COAPROVEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TILCOTIL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040612</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGIZONE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFLON</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SMECTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517929-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>6.2143</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
        <drugdosagetext>SEE TOXICOLOGY TABLE 1</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517934-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04249</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517935-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA00709</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>AORTIC VALVE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>114</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYETHYLENE GLYCOL 3350</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517936-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP13801</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVERSION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZADITEN</medicinalproduct>
        <drugdosagetext>0.8 MG/ DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DERMATITIS ATOPIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
        <drugtreatmentduration>44640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517939-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51.2565</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBELLAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROSMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLODRONATE/PLACEBO</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030414</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4517999-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040807</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12665915</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENACORT</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040807</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENACORT</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>NOCTURNAL DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040807</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENACORT</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040807</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugdosagetext>DURATION OF THERAPY:  MORE THAN 6 YEARS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECOTIDE</medicinalproduct>
        <drugdosagetext>DURATION OF THERAPY:  MORE THAN 6 YEARS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518000-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12775003</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030111</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRIXIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIORFAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZECLAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYAMBUTOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518012-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040202891</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION MISSED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY ON ORAL CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN LO</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN LO</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518019-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040900575</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLON CANCER STAGE II</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518025-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041106871</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OREN-GEDOKU-TO</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OREN-GEDOKU-TO</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OREN-GEDOKU-TO</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTAZOLAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURAZEPAM HCL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE HCL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIHEXYPHENIDYL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECABET SODIUM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RILMAZAFONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518034-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12763728</companynumb>
    <primarysource>
      <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>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUPHENAZINE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOTYPAL PERSONALITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518035-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004AR16470</companynumb>
    <primarysource>
      <qualification>1</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>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE VS PLACEBO</medicinalproduct>
        <drugdosagetext>5 MG, ONCE YEARLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE VS PLACEBO</medicinalproduct>
        <drugdosagetext>DOUBLE BLIND</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518037-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12750519</companynumb>
    <primarysource>
      <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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAMITON</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ODRIK</medicinalproduct>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020417</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518038-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0528438A</companynumb>
    <primarysource>
      <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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MURDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA, PARANOID TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518040-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0532535A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>4PUFF AS REQUIRED</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518041-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0532698A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518045-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0533468A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INADEQUATE CONTROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>332</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAZIDE DIURETIC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518046-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0533469A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
        <drugtreatmentduration>343</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAZIDE DIURETIC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518048-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0533977A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BILE DUCT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518049-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0534843A</companynumb>
    <primarysource>
      <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 CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518050-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0534873A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518051-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0534875A</companynumb>
    <primarysource>
      <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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>1PUFF PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN DM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZONATATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518052-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0534911A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF MUTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>80MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518054-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0535050A</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUFFOCATION FEELING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>B134616</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518055-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535367A</companynumb>
    <primarysource>
      <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518056-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535377A</companynumb>
    <primarysource>
      <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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANOREXIA</drugindication>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518057-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0535406A</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OTOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTAZ</medicinalproduct>
        <drugdosagetext>1G THREE TIMES PER DAY</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518058-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE_041014561</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
        <drugdosagetext>25MGM2 CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>1000MGM2 CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOMEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIFITERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROCIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518059-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535747A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518060-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535890A</companynumb>
    <primarysource>
      <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>AVANDAMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518061-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535891A</companynumb>
    <primarysource>
      <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>AVANDAMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518062-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535905A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518063-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535910A</companynumb>
    <primarysource>
      <qualification>5</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>WELLBUTRIN XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518064-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0337888A</companynumb>
    <primarysource>
      <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>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518065-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES0408USA02143</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CREPITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>160MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOTHIEPIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518066-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040810</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0342692A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXOPROFEN</medicinalproduct>
        <drugdosagetext>60MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040823</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040823</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROTROPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDARABINE</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518067-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040816</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0343218A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugdosagetext>18MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518068-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040903</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-GLAXOSMITHKLINE-B0344969A</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>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518069-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-GLAXOSMITHKLINE-B0346147A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVE UNSPECIFIED</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518070-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0348458A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>38</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLANAX</medicinalproduct>
        <drugdosagetext>.4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518072-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MCA/KP/074</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NABUCOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518073-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0357145A</companynumb>
    <primarysource>
      <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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MODACIN</medicinalproduct>
        <drugdosagetext>1G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>20MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOFLUID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMEDIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALAZOPYRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEILAX</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>ALTAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAIREI-TO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENAMIN</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518074-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0357155A</companynumb>
    <primarysource>
      <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>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>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugdosagetext>250MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENCEPHALITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040614</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>4ML SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040626</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugdosagetext>333MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVIATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERMION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518075-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0357157A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugdosagetext>250MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPETIC STOMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOTIAM HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LARYNGOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAXIZON</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LARYNGOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518076-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0358058A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040815</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518077-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0358059A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETINOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLIXOTIDE</medicinalproduct>
        <drugdosagetext>125U UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALMURID</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>STASIS DERMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPROPYL MYRISTATE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518078-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M24749</companynumb>
    <primarysource>
      <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>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARECOXIB SODIUM</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREOPERATIVE CARE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518079-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0358233A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518080-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0358344A</companynumb>
    <primarysource>
      <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>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEARNING DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518081-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0358427A</companynumb>
    <primarysource>
      <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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPHREN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518082-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0358638A</companynumb>
    <primarysource>
      <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>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518083-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-GLAXOSMITHKLINE-B0358838A</companynumb>
    <primarysource>
      <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>HEPATIC PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPTODIN</medicinalproduct>
        <drugdosagetext>100MG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518084-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-GLAXOSMITHKLINE-B0358881A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMYCOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA EXERCISE INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518085-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-GLAXOSMITHKLINE-B0358914A</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518086-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0045378A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518175-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12776753</companynumb>
    <primarysource>
      <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>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518233-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE622922NOV04</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugauthorizationnumb>50684</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518234-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DL2004280</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD HUMAN CHORIONIC GONADOTROPIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>03006004010</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041010</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518235-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE125927OCT04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>16 MG 1X PER 1 DAY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>16 MG 1X PER 1 DAY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518237-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2004-0017804</companynumb>
    <primarysource>
      <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>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518239-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE646023NOV04</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTROPHY BREAST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>250 MG 2X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS (DIURETICS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518241-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207950</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</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>20001107</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>4518242-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000057</companynumb>
    <primarysource></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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518244-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>204216</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM ABNORMAL</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>20040101</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>20001012</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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518246-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2004-0017702</companynumb>
    <primarysource>
      <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>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518249-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2004-0017703</companynumb>
    <primarysource>
      <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>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518251-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2004-0017819</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518252-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207863</companynumb>
    <primarysource>
      <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>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</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>20030504</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518254-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207884</companynumb>
    <primarysource>
      <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>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>20020201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</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>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518255-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207825</companynumb>
    <primarysource>
      <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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</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>20030206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030301</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>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518257-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207859</companynumb>
    <primarysource>
      <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>CEREBRAL ARTERY EMBOLISM</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>20030425</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>20030801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518258-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>206195</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>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>19971219</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>20030812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040223</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>20040201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518260-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>206464</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL ARTERY OCCLUSION</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>20041102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518262-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>205919</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.0604</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</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>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518264-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>204465</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</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>20020401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</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>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518266-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>205242</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE PROLAPSE</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>20020901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518267-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000023</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.3597</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040426</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518268-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000020</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.1324</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</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>19970101</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>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS (NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518269-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207949</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB 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>19990702</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518270-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>178747</companynumb>
    <primarysource>
      <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>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY MEDIASTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOID TISSUE HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING GRANULOMATOUS LYMPHADENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASMACYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P01029</drugbatchnumb>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</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>COMBIVENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518271-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000019</companynumb>
    <primarysource></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>EMBOLISM</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>20040104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518273-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>201517</companynumb>
    <primarysource>
      <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>BREAST CANCER IN SITU</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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518275-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040818</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>203209</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIASTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</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>20040701</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>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518277-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000077</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>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ATRIAL SEPTAL DEFECT</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>20040123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518278-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000022</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONCUSSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF CRIME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P30043</drugbatchnumb>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518280-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000018</companynumb>
    <primarysource></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>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518281-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000021</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.5234</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</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>19990101</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>4518283-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000017</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30  UG; BIW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30  UG; BIW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518284-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000055</companynumb>
    <primarysource>
      <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>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <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>20030701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518290-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>72001111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>166462</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.4827</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</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>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518293-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004095675</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR CALCIFICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SILDENAFIL (SILDENAFIL)</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518294-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0281560-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.37</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYPTORCHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELFINAVIR MESILATE</medicinalproduct>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE W/LAMIVUDINE</medicinalproduct>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518295-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0275099-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERNATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUTISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC DIABETES INSIPIDUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518297-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-ABBOTT-03P-118-0243991-01</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN LISPRO</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPHANE INSULIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518298-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097884</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APRAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED ACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACIDI (ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKGO BILOBA (GINKGO BILOBA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D (CALCIUM PHOSPHATE, CALCIUM SODIUM LACTATE, ERG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B-KOMPLEX ^LECIVA^ (CALCIUM PANTOTHENATE, NICOTINAMIDE, PYRIDOXINE HYD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST (MONTELUKAST)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC (ZINC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3 TRIGLYCERIDES (OMEGA-3 TRIGLYCERIDES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518299-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097186</companynumb>
    <primarysource>
      <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>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>0350054</drugbatchnumb>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>(20 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMETIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB (CELECOXIB)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518300-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-04908</companynumb>
    <primarysource>
      <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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOR-QD</medicinalproduct>
        <drugauthorizationnumb>17060</drugauthorizationnumb>
        <drugdosagetext>1 TABLET, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518301-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414242BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.9467</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD IRON DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORIGINAL ALKA-SELTZER TABLETS</medicinalproduct>
        <drugbatchnumb>A4A31A</drugbatchnumb>
        <drugdosagetext>650 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORIGINAL ALKA-SELTZER TABLETS</medicinalproduct>
        <drugbatchnumb>A4A31A</drugbatchnumb>
        <drugdosagetext>650 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN AND MINERAL SUPPLEMENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518302-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>QUIN - 296</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO PAIN STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRUDOXIN</medicinalproduct>
        <drugauthorizationnumb>20126</drugauthorizationnumb>
        <drugdosagetext>1 APPLICATION QID TP</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518303-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413947BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48.9885</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
        <drugbatchnumb>279023N</drugbatchnumb>
        <drugdosagetext>2.5 ML, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518304-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04110597</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE PEAKED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPIL FIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>50 MG, QHS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugdosagetext>40 MG/M2, Q 28 DAYS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40 MG, DAYS 1-4 AND 15-18, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518305-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415701BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.0187</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>260153A</drugbatchnumb>
        <drugdosagetext>325 MG, Q4HR, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518306-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04110034</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>200 MG, QHS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040803</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518307-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415688BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.7403</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKA-SELTZER PLUS EFFERVESCENT NIGHT TIME COLD</medicinalproduct>
        <drugbatchnumb>A3K16D</drugbatchnumb>
        <drugdosagetext>500/20/10/12.5 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518308-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0281597-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN BASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518309-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0281527-00</companynumb>
    <primarysource></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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020531</drugenddate>
        <drugtreatmentduration>709</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020531</drugenddate>
        <drugtreatmentduration>709</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPRENAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020531</drugenddate>
        <drugtreatmentduration>80</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518310-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04110117</companynumb>
    <primarysource>
      <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>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</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>20040801</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518311-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0281691-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ODRIK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTAZINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518312-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-ABBOTT-04P-007-0276159-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CERVICAL DYSPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518313-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-04P-062-0279680-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALLORY-WEISS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS LISTERIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
        <drugtreatmentduration>128</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518314-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04110633</companynumb>
    <primarysource>
      <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>PREGNANCY OF PARTNER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSMISSION OF DRUG VIA SEMEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518315-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415589BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.3993</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>0137Y</drugbatchnumb>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>440 MG TID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANDIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518316-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-03832-02</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>15 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>10 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>10 MG QHS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518317-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0279959-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATATONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>IMPORTANT DOSE REGIMEN/1000 MG TO 2000 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>IMPORTANT DOSE REGIMEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>118</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXAPINE SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIHEXYPHENIDYL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
        <drugtreatmentduration>101</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZUCLOPENTHIXOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZUCLOPENTHIXOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROMIDE</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEPROMAZINE</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEPROMETAZINE</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMISULPRIDE</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZUCLOPENTHIXOL</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPRAM TAB</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLORAZEPATE DIPOTASSIUM</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518318-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415324BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>263823C</drugbatchnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518319-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0281416-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518320-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0281416-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518321-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0281416-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
        <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>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>35 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518322-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415379BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.905</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>292744J</drugbatchnumb>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>292744J</drugbatchnumb>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>292744J</drugbatchnumb>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518323-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1000222</companynumb>
    <primarysource>
      <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>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOPHTHALMITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFECTION FUNGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILLARY REFLEX IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>21572</drugauthorizationnumb>
        <drugdosagetext>6 MG/KG; Q24H; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>21572</drugauthorizationnumb>
        <drugdosagetext>6 MG/KG; Q24H; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518324-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0281357-00</companynumb>
    <primarysource></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>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>4MG/240MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518325-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-03P-056-0210750-00</companynumb>
    <primarysource></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>BLOOD BICARBONATE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WRINKLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HELICOBACTER INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugindication>FAMILIAL MEDITERRANEAN FEVER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>HELICOBACTER INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>HELICOBACTER INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEBUTOLOL</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>SPIRONOLACTONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOLSIDOMINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLATE</medicinalproduct>
        <drugdosagetext>LOW DOSAGES</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518326-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0281338-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.572</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROADENOMA OF BREAST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALACTORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRADUCTAL PAPILLOMA OF BREAST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROIDITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19730501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19920101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19920101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518327-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0280947-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>DRUG ABUSER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDINAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANDIDIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILGRASTIM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040215</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>20040216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040216</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518328-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004044965</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE DRUG EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518329-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040819</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-04P-087-0271278-00</companynumb>
    <primarysource></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>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE W/LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518330-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24180</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518331-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MY-ABBOTT-04P-101-0281068-00</companynumb>
    <primarysource></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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENGRAF</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MMF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MMF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031216</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PEPTIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031217</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518332-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ABBOTT-04P-229-0281618-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>B-CELL UNCLASSIFIABLE LYMPHOMA HIGH GRADE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518333-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0281648-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518334-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24182</companynumb>
    <primarysource>
      <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>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518335-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>001-0981-M0002341</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.0083</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SICK SINUS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONIC CLONIC MOVEMENTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS (ASCORBIC ACID, ERGOCALCIFEROL, FOLIC ACID, NICOTINAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN (TERAZOSIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518336-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MY-ABBOTT-04P-101-0281074-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENGRAF</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>75-100 MILLIGRAMS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENGRAF</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID/MONOTARD</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECOBALAMIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN INITARD NORDISK</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN HUMAN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLBID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEPLAST</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIXOGEN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUTOCONAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANBAXYS LESTIC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518337-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040715</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0267473-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.335</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN XL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040508</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAVULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040521</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518338-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW23913</companynumb>
    <primarysource>
      <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>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518339-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-04P-028-0282004-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUFENTANIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE</medicinalproduct>
        <drugdosagetext>3 LITERS PER MINUTE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugdosagetext>3 LITERS PER MINUTE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518340-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0275155-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE ER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
        <drugtreatmentduration>152</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE ER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CONVULSION</drugindication>
        <drugtreatmentduration>152</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</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>LAMOTRIGINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518341-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0278054-00</companynumb>
    <primarysource></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>CHOLECYSTITIS INFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19640101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACLOMEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>DRY EYE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTOXIFYLLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518342-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>001-0981-M0006839</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.5442</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID FACTOR INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 + 80 MG (DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 + 80 MG (DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALCIYLIC ACID (ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518343-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ABBOTT-04P-143-0277006-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>INFECTION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518344-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210597</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugdosagetext>Q3W, INTRVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN (DOXORUBICIN, DOXORUBICIN HDYRICHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUDAFED 12 HOUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN (INGREDIENTS) (MULITIVITAMINS NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518345-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031229</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>189398</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM 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>20021002</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518346-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AC00829</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE LYMPHOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKAEMIA RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEXPECTED THERAPEUTIC DRUG EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
        <drugauthorizationnumb>20498</drugauthorizationnumb>
        <drugdosagetext>50 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOSERELIN</medicinalproduct>
        <drugdosagetext>3.6 MG MONTH SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN</medicinalproduct>
        <drugdosagetext>50 MG/SQ M ON DAY 4 OF TREATMENT</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>300 MG/SQ M EVERY 12 HOURS ON DAYS 1 TO 3 OF TREATMENT</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518347-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24082</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98.429</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERREM</medicinalproduct>
        <drugauthorizationnumb>50706</drugauthorizationnumb>
        <drugdosagetext>1 G Q8H IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518348-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000041</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASTICITY</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>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P30089</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518349-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210726</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>150 MG, 1/MONTH, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR (MONTEKUKAST SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC (CETRIZINE HYDROCHLRIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT AQ (TRIAMCINOLONE ACETONIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR (SALMETEROL XINAFOATE, FLUTICASONE PROPIONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL (ALBUTEROL, ALBUTEROL SULFATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518350-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004079393</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIPHOSPHOLIPID ANTIBODIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC SPACE NARROWING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE ROOT COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE (QUININE SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518351-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MK200412-0008-1</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.7913</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADOSE</medicinalproduct>
        <drugauthorizationnumb>40050</drugauthorizationnumb>
        <drugdosagetext>10 MG TABLETS, 5 TABS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518352-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004084202</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGEMINAL NEURALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN KAPSEAL</medicinalproduct>
        <drugauthorizationnumb>84349</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTIVES NOS (ORAL CONTRACEPTIVES NOS)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (VITAMINS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518353-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096028</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.9874</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN KAPSEAL</medicinalproduct>
        <drugauthorizationnumb>84349</drugauthorizationnumb>
        <drugdosagetext>100 MG (100 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENOBARBITAL (PHENOBARBITAL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL (ENALAPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518354-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TAP2004Q01520</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVPAC</medicinalproduct>
        <drugauthorizationnumb>50757</drugauthorizationnumb>
        <drugdosagetext>0.5 CARD, 2 IN 1 D, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTOROL (GLIPIZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518355-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097024</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.9676</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCIUM DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN KAPSEAL</medicinalproduct>
        <drugauthorizationnumb>84349</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXCARBAZEPINE (OXCARBAZEPINE)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518356-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KII-2004-0014064</companynumb>
    <primarysource>
      <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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALCOHOL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</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>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYSUBSTANCE ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>19516</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINE DERIVATIVES</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL (ETHANOL)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COENZYME Q10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS (PANTHENOL, NICOTINAMIDE,  RBIFLAVIN, THIAMINE HYDROCHLO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C (ASCORBIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE (GLUCOSAMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL PREPARATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/HYDROCODONE BITARTRTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518357-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096880</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.9885</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>2.5 MG (2.5 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugdosagetext>10 MG (10 MG, 1IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL (CANDESARTAN CILEXETIL)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE (BUDESONIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518358-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12098BP</companynumb>
    <primarysource>
      <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>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugauthorizationnumb>20938</drugauthorizationnumb>
        <drugdosagetext>15 MG (7.5 MG, BID), PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518360-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KII-2002-0002403</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>80 MG, Q12H</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518361-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004241303US</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HYDROCHLORIDE SOLUTION, STERILE (IRINOTECAN HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>20571</drugauthorizationnumb>
        <drugdosagetext>183 MG (WEEKLY), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE (THALIDOMIDE)</medicinalproduct>
        <drugdosagetext>400 MG (DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL XINAFOATE (SALMETEROL XINAFOATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518362-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KII-2004-0014074</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>19516</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518363-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098393</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
        <drugauthorizationnumb>20597</drugauthorizationnumb>
        <drugdosagetext>OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESIC BALM (MENTHOL, METHYL SALICYLATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518364-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TAP2004Q01510</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugauthorizationnumb>20406</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE (HYDROCODONE)</medicinalproduct>
        <drugindication>NERVOUS SYSTEM DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518366-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030909</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>179120</companynumb>
    <primarysource>
      <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 OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN GRAFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</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>4518367-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0281523-00</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE INJ</medicinalproduct>
        <drugauthorizationnumb>19916</drugauthorizationnumb>
        <drugdosagetext>2 MG, SINGLE DOSE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POST PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE INJ</medicinalproduct>
        <drugauthorizationnumb>19916</drugauthorizationnumb>
        <drugdosagetext>2 MG, SINGLE DOSE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POST PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518368-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030818</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>177720</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P01030</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000425</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518370-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030905</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>179041</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P30001</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518371-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1003297</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.8331</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF PRESSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APOKYN</medicinalproduct>
        <drugauthorizationnumb>21264</drugauthorizationnumb>
        <drugdosagetext>0.2 MG/ML, ONE DOSE, SUBCUTANEOUSLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CABIDOPA/LEVODOPA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518372-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>178680</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</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>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518374-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030818</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>177647</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</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>20030808</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518375-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>140764USA</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIMOZIDE</medicinalproduct>
        <drugauthorizationnumb>17473</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518377-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030816</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>177545</companynumb>
    <primarysource>
      <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P01029</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518378-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096764</companynumb>
    <primarysource>
      <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>AURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN KAPSEAL</medicinalproduct>
        <drugauthorizationnumb>84349</drugauthorizationnumb>
        <drugindication>GRAND MAL CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518380-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-119878-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABORTION THREATENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVIX DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF MATERNAL EXPOSURE TO THERAPEUTIC DRUGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN HYPERSTIMULATION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE RUPTURE OF MEMBRANES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE CONTRACTIONS DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MENOTROPINS</medicinalproduct>
        <drugauthorizationnumb>17646</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHORIONIC GONADOTROPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518381-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096313</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON BETA (INTERFERON BETA)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518383-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-119877-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABORTION THREATENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVIX DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN HYPERSTIMULATION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE RUPTURE OF MEMBRANES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE CONTRACTIONS DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MENOTROPINS</medicinalproduct>
        <drugauthorizationnumb>17646</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHORIONIC GONADOTROPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518384-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9315</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE FOR UNAPPROVED INDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RUPTURED ECTOPIC PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>11719</drugauthorizationnumb>
        <drugdosagetext>50 MG/M2 PER CYCLE, IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ECTOPIC PREGNANCY TERMINATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518385-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12654</companynumb>
    <primarysource>
      <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>GLEEVEC</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518387-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2004AU01680</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>25 - 750 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518388-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9339</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MACROCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFRACTORY ANAEMIA WITH RINGED SIDEROBLASTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>11719</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>11719</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHY;SA;AZPYRINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518391-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE690706APR04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HELICOBACTER GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>3 MG, 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>1500 MG, 1 X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>8 MG, 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030729</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518392-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE231324NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFEXOR (VENLAFAXINE HYDROCHLORIDE, TABLET, 0) LOT NO.: A63001A</medicinalproduct>
        <drugbatchnumb>A63001A</drugbatchnumb>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>75 MG 1X PER 1 TOT, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOTHIEPIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIHYDROCODEINE (DIHYDROCODEINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE (BECLOMETASONE DIPROPIONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAZINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518393-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE198312NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILD ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARENT-CHILD PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>37.5 MG 2X PER 1 DAY</drugdosagetext>
        <drugindication>POSTPARTUM DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>75 MG 2X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>75 MG 2X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518394-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040519</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP06804</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030817</drugenddate>
        <drugtreatmentduration>14400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031026</drugenddate>
        <drugtreatmentduration>14400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>200 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031109</drugenddate>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>300 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELESTAMINE TAB</medicinalproduct>
        <drugdosagetext>2 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518397-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE191710NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALMANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518398-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE227123NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIPSYCHOTIC DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM REPOLARISATION ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTOLIC HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>100 MG DAILY AND THYEN 150 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>100 MG DAILY AND THYEN 150 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR II DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR II DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE (ZOPICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518400-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE724012OCT04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QRS COMPLEX PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CREPITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROGRADE AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>200 MG TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugdosagetext>6 MG 2 X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040911</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518402-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE624222NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>2 MG 1 X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518403-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030905</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2003GB03514</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON GANGRENE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>900MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMISULPRIDE</medicinalproduct>
        <drugdosagetext>400MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DUODENAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXATIVES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518405-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE237826NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIANOPIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHINYL ESTRADIOL AND LEVONORGESTREL</medicinalproduct>
        <drugauthorizationnumb>19192</drugauthorizationnumb>
        <drugdosagetext>1 TABLET 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040815</drugenddate>
        <drugtreatmentduration>213</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518407-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE117918OCT04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>75 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>10 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518408-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04319</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PIGMENTATION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021218</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518409-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04339</companynumb>
    <primarysource>
      <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>EXOPHTHALMOS CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518410-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE615102MAR04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>4 MG DAILY AT THE TIME OF THE EVENT ONSET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>750 MG 2X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>8 MG DAILY AT THE TIME OF THE EVENT ONSET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE-ALPHA (ALFACALCIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518411-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15796</companynumb>
    <primarysource>
      <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>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NEOPLASM EXCISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISUMIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOSMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEREKINON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518413-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE622422NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASMODIUM FALCIPARUM INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>18989</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041010</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518415-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE623522NOV04</companynumb>
    <primarysource>
      <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>HEPATITIS C VIRUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>2 MG1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT      (MYCOPHENOLAET URSODEOXYCHOLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODEOXYCHOLIC ACID            (URSODEOXYCHOLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518417-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE624522NOV04</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>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>200 MG 5X PER 1 WK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040828</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TADENAN   (PYGEUM AFRICANUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN        (FLUINDIONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IZILOX         (MOXIFLOXACIN,)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040828</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518419-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03402</companynumb>
    <primarysource>
      <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>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518420-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2004A00998</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BENIGN INTRACRANIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROSTAP (LEUPROLIDE ACETATE) (INJECTION)</medicinalproduct>
        <drugauthorizationnumb>20011</drugauthorizationnumb>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518422-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12691</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>UNK,UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518423-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2004A00980</companynumb>
    <primarysource>
      <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 INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>20406</drugauthorizationnumb>
        <drugdosagetext>30 MG (30 MG, 1 IN 1 D) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE (NEVIRAPINE)</medicinalproduct>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>480 MG (480 MG, 1 IN 1 D) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>(2 IN 1 D) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUVAX</medicinalproduct>
        <drugindication>IMMUNISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518424-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE03948</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>MEDICATION ERROR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518425-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004NO15121</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>40 UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBYL</medicinalproduct>
        <drugdosagetext>75 UNK, UNK</drugdosagetext>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>LEVEL 1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518427-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2004A00989</companynumb>
    <primarysource>
      <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>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>20406</drugauthorizationnumb>
        <drugdosagetext>30 MG PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA BLOCKER (BETA BLOCKING AGENTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518428-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2004A03276</companynumb>
    <primarysource>
      <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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSAP         (LANSOPRAZOLE, CLARITHROMYCIN, AMOXICILLIN)</medicinalproduct>
        <drugauthorizationnumb>50757</drugauthorizationnumb>
        <drugdosagetext>1 CARD (0.5 CARD, 2 IN 1 D) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE</medicinalproduct>
        <drugdosagetext>PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518429-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TAP2004Q01523</companynumb>
    <primarysource></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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT</medicinalproduct>
        <drugauthorizationnumb>19732</drugauthorizationnumb>
        <drugdosagetext>7.5 MG (7.5 MG,) INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518430-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPG2004A00302</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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACROANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENILE DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT PSYCHOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRENANTONE      (LEUPROLIDE ACETATE)</medicinalproduct>
        <drugauthorizationnumb>20708</drugauthorizationnumb>
        <drugdosagetext>11.25 MG (11.25 MG, 1 IN 3 M) SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040529</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518431-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2004A00969</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROSTAP (LEUPROLIDE ACETATE)</medicinalproduct>
        <drugauthorizationnumb>20708</drugauthorizationnumb>
        <drugdosagetext>11.25 MG (11.25 MG, 1 IN 1 M)</drugdosagetext>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040429</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROSTAP SR (LEUPROLIDE ACETATE) (UNKNOWN)</medicinalproduct>
        <drugdosagetext>3.75 MG (3.75 MG, 1 IN 1 M)</drugdosagetext>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040206</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE (LEVOTHYROXINE SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518432-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004NO15121</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>40 UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBYL</medicinalproduct>
        <drugdosagetext>75 UNK, UNK</drugdosagetext>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>LEVEL 1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518433-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004NO15121</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>40 UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBYL</medicinalproduct>
        <drugdosagetext>75 UNK, UNK</drugdosagetext>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>LEVEL 1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518434-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>104123ISR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLATIRAMER ACETATE</medicinalproduct>
        <drugauthorizationnumb>20622</drugauthorizationnumb>
        <drugdosagetext>20 MILLIGRAM SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040202</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518435-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>105389ISR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLATIRAMER ACETATE</medicinalproduct>
        <drugauthorizationnumb>20622</drugauthorizationnumb>
        <drugdosagetext>20 MILLIGRAM SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518436-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>105242ISR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLATIRAMER ACETATE</medicinalproduct>
        <drugauthorizationnumb>20622</drugauthorizationnumb>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518437-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>105463ISR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLATIRAMER ACETATE</medicinalproduct>
        <drugauthorizationnumb>20622</drugauthorizationnumb>
        <drugdosagetext>20 MILLIGRAM SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518439-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6011743</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETENSIEL (10 MG, TABLETS) (BISOPROLOL FUMARATE)</medicinalproduct>
        <drugauthorizationnumb>19982</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRACTAZIN (SPIRONOLACTONE, ALTIZIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518441-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE225023NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOPROL (BISOPROLOL, TABLET, 0)</medicinalproduct>
        <drugauthorizationnumb>19982</drugauthorizationnumb>
        <drugdosagetext>5 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ODRIK (TRANDOLAPRIL, , 0)</medicinalproduct>
        <drugdosagetext>2 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRACTAZIN (ALTIZIDE/SPIRONOLACTONE, , 0)</medicinalproduct>
        <drugdosagetext>1 TABLET 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518443-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>25676</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY BONE MARROW ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLECAINIDE ACETATE</medicinalproduct>
        <drugauthorizationnumb>18830</drugauthorizationnumb>
        <drugdosagetext>200 MG (100 MG, 2 IN 1 DAY(S)) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
        <drugtreatmentduration>481</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ART 50 (DIACEREIN)</medicinalproduct>
        <drugdosagetext>100 MG (50 MG, 2 IN 1 ) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
        <drugtreatmentduration>115</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN (FLUINDIONE)</medicinalproduct>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 DAY(S)) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
        <drugtreatmentduration>176</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>600 MG (600 MG, 1 IN 1 DAY(S)) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGIZONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518444-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2004A04240</companynumb>
    <primarysource>
      <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>ATYPICAL MYCOBACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN G INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC GANGRENE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEG AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>30 MG (30 MG, 1 IN 1 D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040430</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN (VOGLIBOSE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SARPOGRELATE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518446-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-06951BP</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugdosagetext>18 MCG (18 MCG), IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518448-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040503</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2002-11-1653</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLOR-TRIMETON</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVIST D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUSS-ORNADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALLS DROPS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALKA-SELTZER PLUS COLD MEDICINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIMETAPP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AFRIN SINUS SPRAY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARIJUANA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518450-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098590</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>144</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugbatchnumb>04243F</drugbatchnumb>
        <drugauthorizationnumb>5845</drugauthorizationnumb>
        <drugdosagetext>1 KAPSEAL ONCE(JUL-2004), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHROPOD BITE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE (GLUCOSAMINE0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN(IBUPROBEN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518451-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-UK-01221UK</companynumb>
    <primarysource>
      <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>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugauthorizationnumb>20938</drugauthorizationnumb>
        <drugdosagetext>15 MG ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugauthorizationnumb>20938</drugauthorizationnumb>
        <drugdosagetext>15 MG ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL (PERINDOPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518452-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004089226</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LENS IMPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISINE II EYE DROPS</medicinalproduct>
        <drugauthorizationnumb>19407</drugauthorizationnumb>
        <drugdosagetext>OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>EYE REDNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISINE TEARS (GLYCERIN, POLYETHYLENE GLYCOL,  HYDROXYPROPYLMETHYLCELLU</medicinalproduct>
        <drugdosagetext>1-2 TIMES DAILY, OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>DRY EYE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518453-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004215219US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROGAINE</medicinalproduct>
        <drugauthorizationnumb>19501</drugauthorizationnumb>
        <drugdosagetext>1 ML BID, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518455-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>140741USA</companynumb>
    <primarysource>
      <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>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>20622</drugauthorizationnumb>
        <drugdosagetext>20 MILLIGRAM QD SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518456-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>140760USA</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>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>20622</drugauthorizationnumb>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518458-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-05011</companynumb>
    <primarysource>
      <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>COMPLEX PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION POTENTIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugauthorizationnumb>70963</drugauthorizationnumb>
        <drugdosagetext>30 MCG SINGLE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NERVE BLOCK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDOCAINE HCL</medicinalproduct>
        <drugdosagetext>150 MG SINGLE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NERVE BLOCK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518460-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-10-1707</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.7913</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>150 MCG QWK SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>1200 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMOVL (SIMVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518462-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BL008458</companynumb>
    <primarysource>
      <qualification>2</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>ALBUTEROL SULFATE</medicinalproduct>
        <drugauthorizationnumb>75050</drugauthorizationnumb>
        <drugdosagetext>OROPHARYNGEAL</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518463-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CIP04001905</companynumb>
    <primarysource>
      <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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugauthorizationnumb>20835</drugauthorizationnumb>
        <drugdosagetext>35 MG ONCE WEEKLY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE W/ESTROGENS/ (ESTROGEN NOS, PROGESTERONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTON PUMP INHIBITORS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518465-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415685BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.6173</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
        <drugbatchnumb>285484C</drugbatchnumb>
        <drugdosagetext>30-45 ML, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518467-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9319</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>76473</drugauthorizationnumb>
        <drugdosagetext>580 MG PER_CYCLE  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518468-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9318</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS TRANSITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>76473</drugauthorizationnumb>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518469-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9334</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugauthorizationnumb>71868</drugauthorizationnumb>
        <drugdosagetext>100 MG/M2 DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN</medicinalproduct>
        <drugdosagetext>45 MG/M2 DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugdosagetext>550 MG/M2 DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE + 600</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518470-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-10813MX</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugdosagetext>80 MG (80 MG, 1 TA O.D.)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040304</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518471-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW23985</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>20272</drugauthorizationnumb>
        <drugdosagetext>1 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518472-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>104605ISR</companynumb>
    <primarysource>
      <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>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>11719</drugauthorizationnumb>
        <drugdosagetext>14 GRAM</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040418</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>900 MILLIGRAM</drugdosagetext>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>100 MILLIGRAM</drugdosagetext>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE SODIUM SUCCINATE</medicinalproduct>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518473-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CIP04002504</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugauthorizationnumb>19651</drugauthorizationnumb>
        <drugdosagetext>1 TABLET, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugauthorizationnumb>19651</drugauthorizationnumb>
        <drugdosagetext>1 TABLET, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518474-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CERZ-10725</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>20367</drugauthorizationnumb>
        <drugdosagetext>6000 UNITS Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518475-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE409609APR04</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.9</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>9 MG/M^2 1X PER 1 DAY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040304</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANDIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM (MULTIVITAMIN/MULTIMINERAL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B-COMPLEX WITH C STRESS FORMULA (VITAMIN B-COMPLEX)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDREA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518476-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0412GBR00002</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIPIDS INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
        <drugtreatmentduration>129</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN ASPART</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518477-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-MERCK-0411NLD00049</companynumb>
    <primarysource>
      <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>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
        <drugtreatmentduration>152</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518478-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0410USA04151</companynumb>
    <primarysource>
      <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>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518479-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA04190</companynumb>
    <primarysource>
      <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>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFACLOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518480-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA02561</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518481-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE676224NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CATECHOLAMINES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518482-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE628827AUG04</companynumb>
    <primarysource></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 LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIRENAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEHISCENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>LOADING DOSE OF 15 MG THEN 5 MG DAILY (EXACT DATES NOT SPECIFIED), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE (QUNINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518483-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE907110NOV03</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>20527</drugauthorizationnumb>
        <drugdosagetext>1 TABLET DAILY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (VITAMINS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>DAILY,ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESTROGEN REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518484-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041008</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA01378</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST MICROCALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHYL SALICYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518485-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0411FRA00104</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518486-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097420</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>151.955</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYCYSTIC OVARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518487-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-0411ESP00035</companynumb>
    <primarysource>
      <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>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518488-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00031</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518489-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03821</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIMOPTIC IN OCUDOSE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518490-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030930</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0309USA03341</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <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>BLOOD PH INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000903</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PLANTAR FASCIITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000903</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO CYCLEN-28</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518491-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004241692US</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITUITARY TUMOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>20280</drugauthorizationnumb>
        <drugdosagetext>6.4 MG (6.4 MG, WK)</drugdosagetext>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011016</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518492-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA02129</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040903</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518493-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-MERCK-0410NZL00105</companynumb>
    <primarysource>
      <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>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST VIRAL FATIGUE SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041003</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041003</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS, CONJUGATED AND MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041024</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518495-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0410CAN00021</companynumb>
    <primarysource>
      <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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518496-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096678</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALDECOXIB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518497-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0401USA01505</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518498-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097531</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
        <drugauthorizationnumb>20607</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518499-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097688</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.9885</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCUSSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC STRESS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARISOPRODOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518500-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207864</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</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>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518501-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207753</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.1637</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518502-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>206673</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P30082</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518503-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>203353</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518504-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0304USA00759</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>95</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACTINIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEBORRHOEIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOLAR ELASTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518505-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-MERCK-0411CHE00046</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518506-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03966</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONNECTIVE TISSUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROBID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518507-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>203295</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</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>20030801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518508-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03191</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>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </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>PAXIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLUENZA VIRUS VACCINE (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021107</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518509-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00798</companynumb>
    <primarysource>
      <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518510-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0411GBR00270</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030924</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>373</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030924</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>373</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSYLLIUM HUSK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>OESTROGEN DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYDROGESTERONE AND ESTRADIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESTROGEN DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930402</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518511-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>202242</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT</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>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518512-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA02516</companynumb>
    <primarysource>
      <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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518513-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030617</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA02099</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOLLICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCIATIC NERVE INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010601</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518514-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>202793</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.6892</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION STAPHYLOCOCCAL</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>20030716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</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>20040601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518515-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207871</companynumb>
    <primarysource>
      <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>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518516-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207860</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518517-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>206637</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR EXCISION</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>4518518-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>204238</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030915</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518519-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>203624</companynumb>
    <primarysource>
      <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>NEUROGENIC BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLGARD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518520-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-MERCK-0411BEL00042</companynumb>
    <primarysource>
      <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>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000330</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518521-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0411CAN00239</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518522-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0304USA00832</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN VASCULAR NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVERSION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GANGLION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENOPAUSAL SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOSOMATIC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORTICOLLIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19681217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19630611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030810</drugenddate>
        <drugtreatmentduration>14671</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AEROBID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518523-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA01537</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>782</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518524-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-US2004-07506</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EISENMENGER'S SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EISENMENGER'S SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518525-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-MERCK-0411GBR00251</companynumb>
    <primarysource>
      <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>DYSAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL STIFFNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSYLLIUM HUSK</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELIPROLOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND CAFFEINE AND CODEINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518526-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03955</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518527-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-US2004-07336</companynumb>
    <primarysource>
      <qualification>1</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>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL EXAMINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</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>20040114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518528-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03874</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518529-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03743</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518530-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03860</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518531-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-US2004-07580</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</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>20040806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518532-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004037837</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLAT FEET</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROTIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>1800 MG (600 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN HUMAN (INSULIN HUMAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE (INSULIN GLARGINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARISOPRODOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORGESIC FORTE (ACETYLSALICYLIC ACID, CAFFEINE, ORPHENADRINE CITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (VITAMINS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518533-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03967</companynumb>
    <primarysource>
      <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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518534-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03810</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518535-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004082915</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEELCHAIR USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>900 MG (300 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER (ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518536-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03994</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518537-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03976</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518538-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03990</companynumb>
    <primarysource>
      <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>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
        <drugtreatmentduration>47</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518539-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004095923</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>1000 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518541-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004095198</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518544-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00027</companynumb>
    <primarysource>
      <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>ANGIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>305</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518545-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04133</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518546-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004091843</companynumb>
    <primarysource></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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>(50 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518547-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04119</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518549-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03995</companynumb>
    <primarysource>
      <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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROTON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMERAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518550-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04168</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518551-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04115</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518552-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04129</companynumb>
    <primarysource>
      <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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518553-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>440001E04USA</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROSTIM</medicinalproduct>
        <drugbatchnumb>4357-2819</drugbatchnumb>
        <drugauthorizationnumb>20604</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROSTIM</medicinalproduct>
        <drugbatchnumb>4357-2819</drugbatchnumb>
        <drugauthorizationnumb>20604</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518555-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03880</companynumb>
    <primarysource>
      <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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518556-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04011</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518557-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00010</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518558-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04163</companynumb>
    <primarysource>
      <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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518559-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>235271K04USA</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, SUBCUTANEOUS; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518560-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00026</companynumb>
    <primarysource>
      <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUADRUPLE VESSEL BYPASS GRAFT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518561-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04059</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518562-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00072</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518563-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>235727K04USA</companynumb>
    <primarysource></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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518564-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00063</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031009</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518566-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-MERCK-0412FIN00002</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040511</drugenddate>
        <drugtreatmentduration>953</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518567-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>430043M04USA</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>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518568-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1447</companynumb>
    <primarysource>
      <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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>MONTHS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>ORAL,MONTHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518569-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AL000157</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE ACCIDENTAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KADIAN (MORHPINE SULFATE SUSTAINED RELEASE) CAPSULES, 100 MG (ALPHARMA</medicinalproduct>
        <drugauthorizationnumb>20616</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES-TTS-2</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAVIK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESOWEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPROLENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METROGEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPSAICIN CREAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518570-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-029004</companynumb>
    <primarysource>
      <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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518571-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0411FRA00064</companynumb>
    <primarysource>
      <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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>246</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GALANTAMINE HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPROBAMATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040210</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518572-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>204672</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.4003</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518573-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>184169</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</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>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LODINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518574-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL098769</companynumb>
    <primarysource>
      <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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518575-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207885</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENITAL DISORDER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P30086</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518576-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA04063</companynumb>
    <primarysource>
      <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>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSMEGEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHABDOMYOSARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHABDOMYOSARCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518577-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00174</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518578-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00059</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518579-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004092309</companynumb>
    <primarysource></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>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>4 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518580-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00035</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518581-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00155</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020621</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518582-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00154</companynumb>
    <primarysource>
      <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518583-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207936</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INITIAL INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</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>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HECTOROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL-XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518584-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207869</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINE FOR DIABETES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518585-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096631</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.5547</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugbatchnumb>546011321</drugbatchnumb>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL (OLMESARTAN MEDOXOMIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM (MINERALS NOS, VITAMINS NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518586-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097464</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19871101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19871101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518587-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097741</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTRENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518588-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04139</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518589-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00534</companynumb>
    <primarysource>
      <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>ANGIOCENTRIC LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF LACTATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIXIVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPINAVIR AND RITONAVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518590-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040914</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0409USA01262</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CALCINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518594-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04019</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518620-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03405</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD KETONE BODY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA LEGIONELLA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE KETONE BODY PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOZINAN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugdosagetext>7.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIXOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAROXYL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNE B6</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040805</drugenddate>
        <drugtreatmentduration>1148</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518675-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE231524NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAMOX</medicinalproduct>
        <drugauthorizationnumb>8943</drugauthorizationnumb>
        <drugdosagetext>1 TABLET 2X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTRAOCULAR PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL (ENALAPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPENTOLATE HYDROCHLORIDE (CYCLOPENTOLATE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINIMS PHENYLEPHRINE (PHENYLEPHRINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYALASE (HYALURONIDASE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMETHOCAINE (TETRACAINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROXYMETACAINE (PROXYMETACAINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518676-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>54756/463</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL GENITOURINARY ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYPTORCHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INGUINAL HERNIA, OBSTRUCTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVONORGESTREL</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPTAC (SODIUM ALGINATE, SODIUM BICARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518677-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>105484ISR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugauthorizationnumb>74084</drugauthorizationnumb>
        <drugdosagetext>300 MILLIGRAM ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>URAPIDIL</medicinalproduct>
        <drugdosagetext>120 MILLIGRAM ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>10 MILLIGRAM ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MILLIGRAM ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>30 MILLIGRAM ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACARBOSE</medicinalproduct>
        <drugdosagetext>150 MILLIGRAM ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518678-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>25666</companynumb>
    <primarysource></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>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDARA</medicinalproduct>
        <drugauthorizationnumb>20723</drugauthorizationnumb>
        <drugdosagetext>(1 SACHET, 3 IN 1 WEEK (S)) TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>CONDYLOMA ACUMINATUM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518679-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6011619</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE FEBRILE NEUTROPHILIC DERMATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALPHA 2 GLOBULIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHLAMYDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOGLOBULINS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL MYELOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROX 100 (TABLETS) (LEVOTHYROXINE SODIUM)</medicinalproduct>
        <drugauthorizationnumb>76187</drugauthorizationnumb>
        <drugdosagetext>1,00 DOSAGE ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLECAINE (FLECAINIDE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENTRICULAR EXTRASYSTOLES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518680-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR9388606JAN2003</companynumb>
    <primarysource></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>LUMBAR PUNCTURE HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>6 MG DAILY AND THEN 4 MG DAILY AT THE TIME OF THE EVENT ONSET ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518681-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE237526NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN FISSURES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>1 MG 1X PER 1 DAY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>1 G 1X PER 1 DAY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERCIAN (CYAMEMAZINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518682-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE236026NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS (SIROLIMUS, TABLET, ))</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>5 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL (PANTOPRAZOLE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHO-MORONAL (AMPHOTERICIN B)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN (AMBROXOL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHROTRANS (SODIUM BICARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPINOL (SULFAMETHOXAZOLE/TRIMETHOPRIM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE AGENT (ANTIHYPERTENSIVE AGENT)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518683-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BEWYE230924NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (CORTICOSTEROIDS, ,0)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518684-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE703230NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLIOBLASTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>4 MG 1X PER 1 DAY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEFFIX (LAMIVUDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518685-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE497017NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMYOTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>200 MG TABLET  , ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELOC (METOPROLOL TARTRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518686-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2004A00140</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IRON INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>30 MG (1 D)</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040119</drugenddate>
        <drugtreatmentduration>67</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518687-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2004A00331</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>15 MG (1 D)  PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040502</drugenddate>
        <drugtreatmentduration>338</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN 10GR TIMED DISINTEGRATION TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACARBOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518688-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2003A03640</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <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 IN 1 D)  PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001126</drugenddate>
        <drugtreatmentduration>210</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DASEN (SERRAPEPTASE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EBASTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RILMAZAFONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMOCAPTRIL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPRAZINONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBROXOL HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518689-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE169529OCT04</companynumb>
    <primarysource>
      <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>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULATION TIME SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANCARON           (AMIODARONE)</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENTRICULAR TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001110</drugenddate>
        <drugtreatmentduration>212</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANCARON           (AMIODARONE)</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENTRICULAR TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040514</drugenddate>
        <drugtreatmentduration>120</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANCARON           (AMIODARONE)</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENTRICULAR TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
        <drugtreatmentduration>1162</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOCHOL (FLUVASTATIN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULCERMIN (SUCRALFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518690-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2004A02278</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>15 MG (15 MG, 1 IN 1 D) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040602</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518691-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2004A00853</companynumb>
    <primarysource></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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>15 MG (15 MG, IN THE MORNING) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040512</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518692-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPG2004A00312</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040721</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518693-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TUK2004A00132</companynumb>
    <primarysource>
      <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>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>15 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE (LEVOTHYROXINE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518694-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2004A00853</companynumb>
    <primarysource>
      <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 GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFAECATION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>15 MG (15 MG, IN THE MORNING), PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040512</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518695-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE964811AUG04</companynumb>
    <primarysource>
      <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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>5 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETYNODIOL DIACETATE         (ETYNODIOL DIACETATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULPHATE (FERROUS SULFATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518696-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BEWYE234825NOV04</companynumb>
    <primarysource>
      <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 BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMTUZUMAB OZOGAMICIN    (GEMTUZUMAB OZOGAMICIN, INJECTION)</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>16.8 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARIVID      (OFLOXACIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518697-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE625022NOV04</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GORDARONE           (AMIODARONE)</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>200 MG 5X PER 1 WK; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
        <drugtreatmentduration>197</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN            (FLUINDIONE )</medicinalproduct>
        <drugdosagetext>20 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXEPA (CITRIC ACID NOS/GLUCOSE/INSULIN/INSULIN HUMAN INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLECAINIDE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFLON (DIOSMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUPRED         (PREDNISOLONE SODIUM SULFOBENZOATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR (ATORVASTATIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518698-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE626922NOV04</companynumb>
    <primarysource>
      <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>ADHESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOMYCIN            (MINOCYLCLINE)</medicinalproduct>
        <drugauthorizationnumb>50649</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYODERMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAVITAN     (FLAVINE ADENINE DINUCLEOTIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518699-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE559319NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOCIN (PIPERACILLIN/TAZOBACTAM)</medicinalproduct>
        <drugauthorizationnumb>50684</drugauthorizationnumb>
        <drugdosagetext>2.5 G 2X PER 1 DAY INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030502</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOY (GABEXATE MESILATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518700-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE228924NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEEDING PROBLEM IN NEWBORN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518701-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE836503SEP04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCAPNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>100 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANAKAN (GINKGO TREE LEAVES EXTRACT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENSIGRADYL (BEMETIZIDE/GUABENXAN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518702-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE227123NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIPSYCHOTIC DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM REPOLARISATION ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTOLIC HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>100 MG DAILY AND THEN 150 MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>100 MG DAILY AND THEN 150 MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR II DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR II DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE (ZOPICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518703-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-DE-05971GL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELMISARTAN (TELMISARTAN)</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugdosagetext>MONTHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>MONTHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugdosagetext>MONTHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROGLYCERINE PATCH (CP)</medicinalproduct>
        <drugdosagetext>MONTHS</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518704-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-10405NB</companynumb>
    <primarysource></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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugdosagetext>40 MG (40 MG)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA N (KA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENIVACE (ENALAPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FURSULTIAMINE (FURSULTIAMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMICRON (GLICLAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HACHIMI-JIO-GAN (PL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOUGHMAC E (TOUGHMAC E) (KA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXAN (AMOXAPINE) (KA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALMARL (AROTINOLOL HYDROCHLORIDE) (TA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANVITAN (PANVITAN) (PL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUDIOMIL (MAPROTILINE HYDROCHLORIDE) (TA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHYPNOL (FLUNITRAZEPAM) (TA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAIKO-KA-RYUKOTSU-BOREI-TO (PL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518705-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>105439ISR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLONIC CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL BONES FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>11719</drugauthorizationnumb>
        <drugdosagetext>15 GRAM</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518706-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9301</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>11719</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETORICOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANASTROZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518707-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9304</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA KLEBSIELLA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>11719</drugauthorizationnumb>
        <drugdosagetext>10 MG WEEKLY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>25 MG 2/WK, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040810</drugenddate>
        <drugtreatmentduration>237</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518708-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9324</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugauthorizationnumb>76108</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040316</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-DYDRAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPRORIONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518709-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8889</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>11719</drugauthorizationnumb>
        <drugdosagetext>12.5 MG WEEKLY, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518710-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-122719-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SLEEP WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>30 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518711-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-115340-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DROWNING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030115</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030120</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518712-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>25675</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENOCORTICAL INSUFFICIENCY CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMBOCOR</medicinalproduct>
        <drugauthorizationnumb>18830</drugauthorizationnumb>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518713-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-UK-01200UK</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE (00015/0215/A) (NEVIRAPINE) (NR)</medicinalproduct>
        <drugauthorizationnumb>20636</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG/TWICE DAILY), PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRUS INFLUENZA (NR)</medicinalproduct>
        <drugdosagetext>SC, ONCE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>2 ANZ (1 ANZ, TWICE DAILY), PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>480 MG (NR, ONCE DAILY), PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE (NR)</medicinalproduct>
        <drugdosagetext>30 MG (NR, ONCE DAILY), PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518714-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20021115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2002-BP-03366BP</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugdosagetext>80 MG (80 MG, 1 TABLET QD), PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugdosagetext>80 MG (80 MG, 1 TABLET QD), PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>80 MG (80 MG, 1 TABLET, QD), PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>80 MG (80 MG, 1 TABLET, QD), PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METORPOLOL (METOPROLOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE (TRIAMTERENE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518715-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004095806</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518716-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004239265US</companynumb>
    <primarysource>
      <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>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>50467</drugauthorizationnumb>
        <drugdosagetext>96 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL (DOCETAXEL)</medicinalproduct>
        <drugdosagetext>190 MG (CYCLICAL), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518717-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004241259US</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLEOCIN HCL</medicinalproduct>
        <drugauthorizationnumb>50162</drugauthorizationnumb>
        <drugdosagetext>600 MG (150 MG, QID), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SIALOADENITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALOXIFENE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518718-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096806</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6996</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>4 MG (4 MG, QD INTERVAL:  EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518719-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>205551</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518720-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>204985</companynumb>
    <primarysource>
      <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>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P30055</drugbatchnumb>
        <drugdosagetext>30 UG; QM; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P30055</drugbatchnumb>
        <drugdosagetext>30 UG; QM; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030819</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518721-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097412</companynumb>
    <primarysource>
      <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 EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH INJECTABLE CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugbatchnumb>13JBT</drugbatchnumb>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugbatchnumb>13JBT</drugbatchnumb>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040409</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518722-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004094849</companynumb>
    <primarysource>
      <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>ANION GAP INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISTARIL</medicinalproduct>
        <drugauthorizationnumb>11111</drugauthorizationnumb>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOROLAC TROMETHAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM CITRATE (MAGNESIUM CITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOLYTELY (MACROGOL, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISICOL (SODIUM PHOSPHATE DIBASIC, SODIUM PHOSPHATE MONOBASIC (MONOHYD</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518723-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210646</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>5 MG/KG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518724-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-10869</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTERIOVENOUS FISTULA SITE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</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>20040211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHROVITE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518725-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US014114</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugauthorizationnumb>20747</drugauthorizationnumb>
        <drugdosagetext>400 UG  Q4HR BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518726-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12099BP</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugauthorizationnumb>20579</drugauthorizationnumb>
        <drugdosagetext>0.4 MG (0.4 MG, 1 QD), PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY RETENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>150 MG, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518727-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>140736USA</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.9363</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADIPEX-P</medicinalproduct>
        <drugauthorizationnumb>85128</drugauthorizationnumb>
        <drugdosagetext>37.5 MILLIGRAM QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WEIGHT CONTROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518728-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CERZ-10715</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</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>19970616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518729-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>140752USA</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>70541</drugauthorizationnumb>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518730-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004093669</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LISTLESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE STOOLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP TALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS (ANTIBIOTICS)</medicinalproduct>
        <drugindication>FEELING ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS (ANTIBIOTICS)</medicinalproduct>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAXATIVES (LAXATIVES)</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518731-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12097BP</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>20636</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE (STAVUDINE)</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE (LAMIVUDINE)</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518732-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003-12-1463</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SJOGREN'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVENTIL-HFA</medicinalproduct>
        <drugbatchnumb>GDJ001A</drugbatchnumb>
        <drugauthorizationnumb>20503</drugauthorizationnumb>
        <drugdosagetext>ORAL AER INH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR (SALMETEROL/FLUTICASONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFUROXIME</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518733-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030523</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>03USA0021</companynumb>
    <primarysource>
      <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>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIADEL</medicinalproduct>
        <drugauthorizationnumb>20637</drugauthorizationnumb>
        <drugdosagetext>8 WAFERS, IMPLANT</drugdosagetext>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518734-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030813</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>03USA0025</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.9874</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIADEL</medicinalproduct>
        <drugauthorizationnumb>20637</drugauthorizationnumb>
        <drugdosagetext>6 WAFERS, IMPLANT</drugdosagetext>
        <drugindication>OLIGODENDROGLIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO 14/14</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518735-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-120145-NL</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUNNEL VISION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLESSA</medicinalproduct>
        <drugauthorizationnumb>21090</drugauthorizationnumb>
        <drugdosagetext>1 DF QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLESSA</medicinalproduct>
        <drugauthorizationnumb>21090</drugauthorizationnumb>
        <drugdosagetext>1 DF QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSMENORRHOEA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518736-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-035499</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518737-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-033950</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>UA1244A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS /USA/ (PIOGLITAZONE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE (METFORMIN HYDROCHLORIDE, GLIBENCLAMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE W/APAP (HYDROCODONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518738-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-034444</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.7</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMVIR /NET/ PENCICLOVIR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX ^PHARMACIA^ (PANTOPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518739-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207948</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518740-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-01</companynumb>
    <primarysource>
      <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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KUSSMAUL RESPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO PAIN STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE W/LAMIVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGESTIN INJ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTICONVULSANT NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANGIOTENSIN RECEPTOR ANTAGONIST NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALDECOXIB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518741-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_81138_2004</companynumb>
    <primarysource>
      <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>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugauthorizationnumb>21196</drugauthorizationnumb>
        <drugdosagetext>4.5 G NIGHTLY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CATAPLEXY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugauthorizationnumb>21196</drugauthorizationnumb>
        <drugdosagetext>4.5 G NIGHTLY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NARCOLEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXEDRINE LA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518742-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_81054_2004</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.8957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugbatchnumb>A00970</drugbatchnumb>
        <drugauthorizationnumb>21196</drugauthorizationnumb>
        <drugdosagetext>VAR NIGHTLY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugbatchnumb>A00970</drugbatchnumb>
        <drugauthorizationnumb>21196</drugauthorizationnumb>
        <drugdosagetext>VAR NIGHTLY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugbatchnumb>A00970</drugbatchnumb>
        <drugauthorizationnumb>21196</drugauthorizationnumb>
        <drugdosagetext>VAR NIGHTLY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugdosagetext>60 MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEROSEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518743-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-07514-01</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAMMONAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA HAEMOPHILUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>300 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>80 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>20 TABLET ONCE</drugdosagetext>
        <drugindication>ISCHAEMIC STROKE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG QD</drugdosagetext>
        <drugindication>ISCHAEMIC STROKE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>130 MG ONCE</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>4 G ONCE</drugdosagetext>
        <drugindication>CONVERSION DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>125 MG BID</drugdosagetext>
        <drugindication>CONVERSION DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugindication>CONVERSION DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.5 MG TID</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>5 MG TID</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIGRANAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518744-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000060</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONCUSSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</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>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518745-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207953</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</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>19990625</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>4518746-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207862</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <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>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518747-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-028454</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020522</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518748-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2003-0010481</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91.6</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ETHANOL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE ACCIDENTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL (ETHANOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELLERGAL-S (PHENOBARBITAL, ERGOTAMINE TARTRATE, BELLADONNA ALKALOIDS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX ^CERENEX^ (SUMATRIPTAN SUCCINATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOBENZAMIDE (TRIMETHOBENZAMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518749-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_25386_2004</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDIZEM LA</medicinalproduct>
        <drugauthorizationnumb>21392</drugauthorizationnumb>
        <drugdosagetext>240 MG QAM PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518750-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207822</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</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>20031219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518751-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207757</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LISTLESS</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>20011109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</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>20031105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040417</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>20040624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040806</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518752-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>206684</companynumb>
    <primarysource>
      <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>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</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>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS (NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518753-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-035317</companynumb>
    <primarysource>
      <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>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518754-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-034107</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>158.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518815-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20041106660</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugbatchnumb>03330822</drugbatchnumb>
        <drugdosagetext>05.0 ML IN 050 ML DILUENT AT 04.0 ML/H</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugbatchnumb>03330822</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE</medicinalproduct>
        <drugbatchnumb>04330030</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACE INHIBITOR NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518816-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20041105673</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>FIRST INFUSION.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518817-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105877</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTOCORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLESTID</medicinalproduct>
        <drugdosagetext>1-2 PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518818-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105919</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.43</patientweight>
      <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>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518819-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041106015</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA OF SKIN</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>4518820-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041106019</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.16</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOSEQUAMAN</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518821-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041106030</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAECAL OCCULT BLOOD POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM SICKNESS</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>4518822-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041106059</companynumb>
    <primarysource>
      <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>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518823-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041106060</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CUSHINGOID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</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>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518824-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041106064</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</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>DISTAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518825-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041106078</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</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>DISTAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518826-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041106110</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URBASON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URBASON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URBASON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518827-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-JNJFOC-20041106171</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518828-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041106349</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.38</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518829-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041106369</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>FIRST INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518830-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041106370</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.22</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <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>DIPENTUM</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518831-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041106384</companynumb>
    <primarysource>
      <qualification>1</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>FIRST TREATMENT</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518832-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041106400</companynumb>
    <primarysource>
      <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>AORTIC VALVE REPLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>PATIENT HAS BEEN ON INFLIXIMAB FOR 6-8 MONTHS.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518833-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20041106478</companynumb>
    <primarysource>
      <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>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518834-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041100499</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</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>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518835-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041102265</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
      </drug>
      <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>4518836-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040805688</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102.06</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>TOTAL NUMBER OF INFUSIONS= 11</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518837-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041006963</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATYPICAL MYCOBACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</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>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INH</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518838-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-JNJFOC-20041102051</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIFFUSE LARGE B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC-K</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOSTIGMINE BROMIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>MYASTHENIA GRAVIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518839-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20041102504</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>4TH DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3RD DOSE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518840-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040908973</companynumb>
    <primarysource>
      <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>SJOGREN'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>04C193A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>04C193A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>04C193A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>04C193A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>04C193A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>04C193A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>6-MP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>6-MP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLAZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518841-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NSADSS2002022915</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.91</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SMALL CELL LUNG CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>6-MP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518842-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041003739</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.38</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>04G093A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518843-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041102364</companynumb>
    <primarysource>
      <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>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROIDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>SECOND DOSE</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>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518844-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20040200932</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.5</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMYOTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BULBAR PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>FIFTH INFUSION</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TPN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518845-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041103944</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-DYDRAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-DYDRAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518846-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040900450</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.28</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN G INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3 OR 4 VIALS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3 OR 4 VIALS</drugdosagetext>
        <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>DOSE INCREASED TO FOUR VIALS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>DOSE = 3 VIALS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>DOSE =  3 VIALS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>DOSE = 3 VIALS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3 OR 4 VIALS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>DISCONTINUED AFTER INFUSION REACTIONS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>STARTED AFTER LEFLUNOMIDE WAS DISCONTINUED.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518847-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20040905778</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII 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>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INH</medicinalproduct>
        <drugindication>TUBERCULOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOT</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAZUREN S</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518848-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040803357</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.02</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>04A034A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>04A034A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>04A034A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>04A034A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>04A034A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>04A034A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>04A034A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>04A034A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>04A034A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>04A034A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>04A034A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>04A034A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>04A034A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>04A034A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTISPASMODIC</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANTS</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518849-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040803381</companynumb>
    <primarysource>
      <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>HYPERBILIRUBINAEMIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>04A034A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>04A034A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>04A034A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>04A034A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>04A034A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>04A034A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>04A034A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>04A034A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>04A034A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>04A034A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>04A034A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>04A034A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>04A034A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>04A034A</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTISPASMODIC</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518850-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20040201526</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIUM AVIUM COMPLEX INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOUS PLEURISY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3MG/KG</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3MG/KG</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3MG/KG</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMATIL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518851-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07679-01</companynumb>
    <primarysource>
      <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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOREA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOGORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIXED AMPHETAMINE SALTS</medicinalproduct>
        <drugdosagetext>45 MG TID</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIXED AMPHETAMINE SALTS</medicinalproduct>
        <drugdosagetext>20 MG BID</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIXED AMPHETAMINE SALTS</medicinalproduct>
        <drugdosagetext>30 MG TID</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518852-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421060BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugauthorizationnumb>19537</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518853-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415588BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORIGINAL ALKA-SELTZER TABLETS</medicinalproduct>
        <drugbatchnumb>A4FO</drugbatchnumb>
        <drugdosagetext>1300 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>289034E</drugbatchnumb>
        <drugdosagetext>81 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>289034E</drugbatchnumb>
        <drugdosagetext>81 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (PURITAN BRAND)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518854-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415612BCC</companynumb>
    <primarysource></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>RENAL ATROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>280223P</drugbatchnumb>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>220 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518855-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415653BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>279483N</drugbatchnumb>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>220 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>274043J</drugbatchnumb>
        <drugdosagetext>220/120 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518856-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415684BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.0604</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518857-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415691BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDOL</medicinalproduct>
        <drugdosagetext>500/25/15 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENSTRUAL DISORDER</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518858-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KII-2004-0014025</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BARBITURATES POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPIATES POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARISOPRODOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINE DERIVATIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518859-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24085</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518860-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KII-2001-0001375</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518861-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0281609-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL VARICES HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPRENAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021115</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030130</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021115</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518862-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KII-2004-0014047</companynumb>
    <primarysource>
      <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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSMOLAR GAP ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILS UNEQUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518863-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040301</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ABBOTT-04P-114-0251882-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXANTHEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATORENAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030919</drugenddate>
        <drugtreatmentduration>53</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
        <drugtreatmentduration>53</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>600 MG AND 400 MG DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030919</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXCARBAZEPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518864-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-10-0069</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>APALLIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAUSTIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>115 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRAIN NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518865-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>0104-1976</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVICOR</medicinalproduct>
        <drugauthorizationnumb>21249</drugauthorizationnumb>
        <drugdosagetext>2 TABLET (S) QHS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVICOR</medicinalproduct>
        <drugauthorizationnumb>21249</drugauthorizationnumb>
        <drugdosagetext>2 TABLET (S) QHS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518866-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210436</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR (FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518867-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004029619</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSPASM CORONARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ACNEIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>100 MG (100 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
        <drugdosagetext>1200 MG (600 MG 2 IN 1 D) ,ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
        <drugdosagetext>5 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugdosagetext>1200 MG (600 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518868-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413628JP</companynumb>
    <primarysource>
      <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>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518869-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413531EU</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031127</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518870-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW23911</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518871-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12775136</companynumb>
    <primarysource>
      <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>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORSET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
        <drugtreatmentduration>316</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DI-ANTALVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENANTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODOPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518872-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12776357</companynumb>
    <primarysource>
      <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>ENDOPHTHALMITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENACORT-A INJ</medicinalproduct>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>DIABETIC RETINOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040127</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518873-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BRISTOL-MYERS SQUIBB COMPANY-12776985</companynumb>
    <primarysource>
      <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>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518874-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12775763</companynumb>
    <primarysource>
      <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>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUPHENAZINE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEPRONIZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKINE CHRONO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518875-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12776456</companynumb>
    <primarysource>
      <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>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIPARINE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518876-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030327</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12223970</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACQUIRED CARDIAC SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPOSITION OF THE GREAT VESSELS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ECAZIDE TABS 50 MG/25 MG</medicinalproduct>
        <drugdosagetext>DOSE: 50 MG/25 MG TABLETS.</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518877-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE558919NOV04</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZENAPAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS (CORTICOSTEROID NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518878-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SUS1-2004-00635</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANISOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELLIPTOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE MORPHOLOGY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACROCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL TOXIC GRANULATION PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET AGGREGATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POIKILOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYCHROMASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL TARGET CELLS PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STASIS DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGRYLIN</medicinalproduct>
        <drugauthorizationnumb>13970</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 3X/DAY:TID,</drugdosagetext>
        <drugindication>POLYCYTHAEMIA VERA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDREA (HYDOXYCARBAMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR (FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGIC MOUTH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518879-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US11264</companynumb>
    <primarysource>
      <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>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISUDYNE</medicinalproduct>
        <drugbatchnumb>00944A</drugbatchnumb>
        <drugauthorizationnumb>21119</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISUDYNE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518880-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12775987</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518881-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-BRISTOL-MYERS SQUIBB COMPANY-12748760</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugindication>CACHEXIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518882-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12774808</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518883-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414434FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>805</patientonsetageunit>
      <patientweight>2.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COARCTATION OF THE AORTA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE CONGENITAL ABNORMALITIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ATRESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELFAST</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRONCHODUAL</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLIXONASE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AERIUS</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZADITEN</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518884-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414440FR</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVE PILL NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOSUPPRESSIVE AGENTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518885-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421694GDDC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOMAX</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518886-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419148US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518887-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413552JP</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>38</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEDERCORT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVEN EP</medicinalproduct>
        <drugdosagetext>DOSE: 3 CAPS/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONALON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518888-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410216JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BACTERIA SPUTUM IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BETA-D-GLUCAN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN DEGRADATION PRODUCTS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DIATHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BREDININ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>DOSE: 6MG/WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugdosagetext>DOSE: 10MG/WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STOMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SHIOSOL</medicinalproduct>
        <drugdosagetext>DOSE: 10MG/WEEK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PL GRAN.</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLELOCK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARICID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031128</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518889-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SUS1-2004-00788</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL 12.5</medicinalproduct>
        <drugauthorizationnumb>11522</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518890-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE558019NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>20402</drugauthorizationnumb>
        <drugdosagetext>1-2 CAPSULES EVERY 4-6 HOURS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518891-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE017325OCT04</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>11.35</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S ADVIL</medicinalproduct>
        <drugbatchnumb>A73613</drugbatchnumb>
        <drugauthorizationnumb>20589</drugauthorizationnumb>
        <drugdosagetext>3/4 TEASPOON ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TEETHING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518892-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004EN000083</companynumb>
    <primarysource>
      <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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GASES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAT EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOSPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITUITARY INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABELCET</medicinalproduct>
        <drugauthorizationnumb>50724</drugauthorizationnumb>
        <drugdosagetext>450 MG; QD; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CRYPTOCOCCOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugdosagetext>85 MG;QD;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CRYPTOCOCCOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCYTOSINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518893-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004US001438</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF (TACROLIMUS)</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>2.00 MG , BID</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL)</medicinalproduct>
        <drugdosagetext>1000.00 MG , BID</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>30.0 MG, UID/QD</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518894-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004072737</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518895-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-04432</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICROGESTIN FE 1.5/30</medicinalproduct>
        <drugbatchnumb>63103A03</drugbatchnumb>
        <drugauthorizationnumb>75548</drugauthorizationnumb>
        <drugdosagetext>1 TABLET, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040618</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518896-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-00830</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>CARDIOMYOPATHY ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518897-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RS004835-USA</companynumb>
    <primarysource>
      <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>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518898-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-0007757</companynumb>
    <primarysource>
      <qualification>2</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>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>21752</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518899-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04110185</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518900-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-041105533</companynumb>
    <primarysource>
      <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>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518901-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004US001449</companynumb>
    <primarysource>
      <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>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANTED LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL T-CELL LYMPHOMA UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518902-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04100640</companynumb>
    <primarysource>
      <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>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID (THALIDOMIDE) (50 MILLIGRAM, CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518903-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04100677</companynumb>
    <primarysource>
      <qualification>1</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>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANTLE CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>200 TO 400MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518904-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04100672</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE DRUG EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518905-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_81033_2004</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>105.6881</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATAPLEXY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELAYED SLEEP PHASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugauthorizationnumb>21196</drugauthorizationnumb>
        <drugdosagetext>6 G NIGHTLY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CATAPLEXY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugdosagetext>9 G NIGHTLY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CATAPLEXY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugdosagetext>6 G NIGHTLY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CATAPLEXY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugdosagetext>4.5 G NIGHTLY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CATAPLEXY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030304</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NARCOTIC PILLS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </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>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518906-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-07493-01</companynumb>
    <primarysource>
      <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>ANOSMIA</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>20041107</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>20041107</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>20041010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</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>20041010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518907-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW23847</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518908-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW15424</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.2043</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>800 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DDAVP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518909-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-2004-035487</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugauthorizationnumb>20038</drugauthorizationnumb>
        <drugdosagetext>50 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugauthorizationnumb>20038</drugauthorizationnumb>
        <drugdosagetext>50 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518910-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-2004-031448</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF BONE MARROW TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED IMMUNE RESPONSIVENESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPAPLASTIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE MORPHOLOGY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugauthorizationnumb>20038</drugauthorizationnumb>
        <drugdosagetext>54 MG, 1X/DAY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIOTEPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTITHYMOCYTE IMMUNOGLOBULIN (RABBIT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>............</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN (FLUCONAZOLE) CAPSULE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBENIN (BETAMIPRON, PANIPENEM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT (LEVOFLOXACIN) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISODINE (PROVIDONE-IODINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE (CARBOCISTEINE) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VEEN-F</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518911-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEU-2004-0001118</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALLADON  (HYDROMORPHONE HCL CR )</medicinalproduct>
        <drugauthorizationnumb>21044</drugauthorizationnumb>
        <drugdosagetext>4 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518912-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_25385_2004</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEVETEN</medicinalproduct>
        <drugauthorizationnumb>20738</drugauthorizationnumb>
        <drugdosagetext>600 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518913-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>4ZP3061</drugbatchnumb>
        <drugdosagetext>100/50 1 INHALATION TWICE DAILY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518914-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101.6057</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRIAPISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugdosagetext>140 MG QHS</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISTARIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518915-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</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>PROPOXYPHENE HCL 100 MG</medicinalproduct>
        <drugdosagetext>Q 4H PRN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL 100 MG</medicinalproduct>
        <drugdosagetext>Q 4H PRN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518916-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>1 QD</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518917-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>148 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>5 FU 7800 MG</drugdosagetext>
        <drugindication>ANAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION</medicinalproduct>
        <drugdosagetext>DAILY X 29 DAYS</drugdosagetext>
        <drugindication>ANAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518918-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.3597</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>300 MG TID</drugdosagetext>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518919-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>20 MG QD</drugdosagetext>
        <drugindication>SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LO SARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518920-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>20 MG Q 12 H PRN</drugdosagetext>
        <drugindication>SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANCEF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518921-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_25436_2004</companynumb>
    <primarysource>
      <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>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTENSOR PLANTAR RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
        <drugauthorizationnumb>17794</drugauthorizationnumb>
        <drugdosagetext>1 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAZINE</medicinalproduct>
        <drugdosagetext>50 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugdosagetext>20 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>300 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>150 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>150 MG  BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>200 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>600 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020816</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518922-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004227007JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>1 MG INTERVEL, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZOSEMIDE (AZOSEMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTITOL (LACTITOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518923-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.5651</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>500 MG/DAY ORAL 10 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518924-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47.6277</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25 MG DAILY</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>12 MG IN HOSP.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518925-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-2004-031267</companynumb>
    <primarysource>
      <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>LEVONORGESTREL</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVONORGESTREL</medicinalproduct>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVONORGESTREL</medicinalproduct>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040729</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518926-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-2004-033264</companynumb>
    <primarysource>
      <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>GENITAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE CONTRACEPTIVE DEVICE EXPELLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040529</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518927-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASCION CLEANSER</medicinalproduct>
        <drugbatchnumb>EB4300305</drugbatchnumb>
        <drugdosagetext>SMALL AMOUNT TOPICAL DAILY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFERIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518928-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1448</companynumb>
    <primarysource>
      <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>TALIPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugauthorizationnumb>20503</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALBUTAMOL SULPHATE ORAL AEROSOL ^PROVENTIL HFA^</medicinalproduct>
        <drugdosagetext>ORAL AER INH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLUENZA VIRUS VACCINE INJ SOLN - MONOTHERAPY</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERMETHRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030916</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518929-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.2867</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>4 MG/ KG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>80 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>AUC 6 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>AUC 6 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBITUSSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518930-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBR-2004-0001380</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STARING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>19516</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020903</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518931-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.4932</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>80 MG Q 8 HRS</drugdosagetext>
        <drugindication>DECUBITUS ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>80 MG Q 8 HRS</drugdosagetext>
        <drugindication>PARAPLEGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518932-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004-1682</companynumb>
    <primarysource>
      <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>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NYDRAZID</medicinalproduct>
        <drugauthorizationnumb>8662</drugauthorizationnumb>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIMACTANE</medicinalproduct>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518933-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.7507</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>IV ONCE WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>IV ONCE WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>IV ONCE WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct> AMIFORINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518934-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.8331</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>2 TABS PO QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SURGERY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>3 TABS PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518935-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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 GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>40 MG BID X 5 D</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE EXACERBATED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518936-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EM2004-0597</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>31.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN E INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBI</medicinalproduct>
        <drugauthorizationnumb>50753</drugauthorizationnumb>
        <drugdosagetext>150 MG, INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULTANOL (SALBUTAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXIS (FORMOTEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAFEM (LORACARBEF)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIGANTOLETTEN (COLECALCIFEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVIT (TOCOPHERYL ACETATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KREON (PANCREATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518937-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERELAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518938-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.4306</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugdosagetext>160 MG 1 PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518939-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.4514</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>150 MG BID</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518940-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>LORAZAEPAM</medicinalproduct>
        <drugdosagetext>1 MG BID</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518941-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugdosagetext>GIVEN Q2 WEEKS</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE PER PROTOCOL H3EUSJMGC</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCUM/VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518942-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugdosagetext>40 MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518943-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>MED RECORD NOT AVAILABLE ~ 500 MG Q HO</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980501</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518944-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200409193</companynumb>
    <primarysource></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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STREPTOKINASE (STREPTOKINASE)</medicinalproduct>
        <drugdosagetext>1.5 MIU DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040722</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518945-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.8748</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>ONCE IN MORNING SWALLOWED W/ WATER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENTAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518946-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-2004-035209</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CERVICAL DYSPLASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>21098</drugauthorizationnumb>
        <drugdosagetext>1 TAB (S), 24/28 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040414</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518947-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>UK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISORDIL MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518948-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200054</companynumb>
    <primarysource>
      <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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</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>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040531</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>20030519</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518949-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004095233</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>0</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>1.8 GRAM, PLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>2 MG, PLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugdosagetext>100 MG, PLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518950-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>80 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990405</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518951-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2004-035516</companynumb>
    <primarysource>
      <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>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY CIRRHOSIS PRIMARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS PROLIFERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IUCD COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL INTERSTITIAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENERAL ANAESTHESIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518952-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518953-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004075229</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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 IMMUNOGLOBULIN E INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTIC INFILTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040819</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518954-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RYTHMOL</medicinalproduct>
        <drugbatchnumb>03RYT11007</drugbatchnumb>
        <drugdosagetext>150 MG 3 TIMES DAILY BY MOUTH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WOLFF-PARKINSON-WHITE SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518955-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097530</companynumb>
    <primarysource>
      <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>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
        <drugauthorizationnumb>20287</drugauthorizationnumb>
        <drugdosagetext>2500 I.U (DAILY)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518956-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>114.3065</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN 5 MG</medicinalproduct>
        <drugdosagetext>5 MG QD</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN 5 MG</medicinalproduct>
        <drugdosagetext>5 MG QD</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518957-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097550</companynumb>
    <primarysource>
      <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>EXANTHEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>21130</drugauthorizationnumb>
        <drugdosagetext>1200 MG (600 MG, TWICE DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FISTULA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARKEMED (MEFENAMIC ACID)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE ESOMEPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (POTASSIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518958-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE (CAPSULES) WATSON</medicinalproduct>
        <drugdosagetext>100 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518959-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004220428FR</companynumb>
    <primarysource>
      <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>MANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>9986</drugauthorizationnumb>
        <drugdosagetext>100 MG (DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugdosagetext>200 MG (DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN NM (KETOPROFEN)</medicinalproduct>
        <drugdosagetext>300 MG (DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugdosagetext>600 MG (DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BCG VACCINE 9BCG VACCINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC (DICLOFENAC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFAN (CAFFEINE , CARBASALATE CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518960-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>2 TSP QD</drugdosagetext>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518961-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004230289DE</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOLATE DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD AVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID TABLET    (LINEZOLID)</medicinalproduct>
        <drugauthorizationnumb>21130</drugauthorizationnumb>
        <drugdosagetext>1200 MG (600 MG, TWICE DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA BLOCKING AGENTS (BETA BLOCKING AGENTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN (CYANOCOBALAMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID 9FOLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRUM HAUSMANN             (FERROUS FUMARATE, SACCHARATED IRON OXIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518962-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, SC, TWICE WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518963-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097457</companynumb>
    <primarysource>
      <qualification>5</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>40 MG (40 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518964-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096022</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>(1500 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>............</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL (SALMETEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUMATRIPTAN (SUMATRIPTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLIZINE (CYCLIZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPIPANONE (DIPIPANONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE (FLOXETINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518965-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2004-05460</companynumb>
    <primarysource>
      <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>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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE           (FLUTICASONE PROPIONATE, SALMETEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518966-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102.3</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANT SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>4400MG  QD INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>4400MG  QD INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSULFAN</medicinalproduct>
        <drugdosagetext>74MG  QD INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040828</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACITRACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518967-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTOCOR  ANDRX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518968-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>COMPARTMENT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>DAILY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>6 MG  DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NALTREXONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518969-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBYAX</medicinalproduct>
        <drugdosagetext>QAM   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518970-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.5244</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugbatchnumb>140956</drugbatchnumb>
        <drugdosagetext>450  MG OVER 24 HR INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518971-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>20MG  QHS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518972-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.173</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIFFUSE LARGE B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>100/M2   X 9 DAYS  INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugdosagetext>7609 TOTAL DAILY INTRATUMOR</drugdosagetext>
        <drugadministrationroute>036</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000216</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518973-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.4514</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAFCILLIN SODIUM</medicinalproduct>
        <drugbatchnumb>128743</drugbatchnumb>
        <drugdosagetext>2 GRAMS   EVERY 4 HOURS  INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518974-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2004-06203</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALPHA 1 FOETOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT NON-RESECTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROVEL (IRBESARTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN (FLUINDIONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTAZINE (ALTIZIDE, SPIRONOLACTONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518975-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004095402</companynumb>
    <primarysource>
      <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>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORTIS (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL (CLOPIDOGREL)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518976-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.2762</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL SUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LUTEINISING HORMONE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TESTOSTERONE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugdosagetext>800MG  DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DECREASED APPETITE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</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>PENICILLIN G POTASSIUM INJ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRAZINAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518977-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>30  MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518978-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.3899</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10MG  DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518979-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004076689</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DIATHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>5 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN LISPRO                     (INSULIN LISPRO)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518980-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>124.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENA CAVA THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>1800  IV INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEURILEMMOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXICODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZONATATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON SULFATETHIAMIN COMPOUND TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518981-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>123</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>40MG  QHS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHAGAN P</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518982-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004078000</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE MB INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST-T SEGMENT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>40 MG (40 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMETIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518983-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORFLOXACIN</medicinalproduct>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19931001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19931101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORFLOXACIN</medicinalproduct>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19931001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19931101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORFLOXACIN</medicinalproduct>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19971102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORFLOXACIN</medicinalproduct>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19971102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518984-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.3993</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugdosagetext>ONE DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518985-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>500 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>500 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEPHROLITHIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>500 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518986-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004095957</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATOMYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugauthorizationnumb>19949</drugauthorizationnumb>
        <drugdosagetext>1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENOXYMETHYL PENICILLIN</medicinalproduct>
        <drugdosagetext>1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>100 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugdosagetext>100 MG (100 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040503</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518987-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.1324</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL 12.5</medicinalproduct>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518988-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENTERACEPT  25 MG  AMGEN</medicinalproduct>
        <drugbatchnumb>035943</drugbatchnumb>
        <drugdosagetext>25 MG BIW SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518989-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugdosagetext>ONE INJECTION INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518990-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>700MG/M2 EVERY 22 DAYS</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400MG/DAY</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518991-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004091200</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDURA XL</medicinalproduct>
        <drugauthorizationnumb>19668</drugauthorizationnumb>
        <drugdosagetext>4 MG (4 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518992-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004079973</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>39.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATOMYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUADRIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>5 MG (5 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL (CANDESARTAN CILEXETIL)</medicinalproduct>
        <drugdosagetext>4 MG (4 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODEOXYCHOLIC ACID (URSODEOXYCHOLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIASTASE, TAKA (DIASTASE, TAKA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROVITAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIZOLAM (ETIZOLAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518993-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITIN-D</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIHISTAMINE THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugindication>INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA FRUIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518994-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200300434</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX PURIFIED NEUROTOXIN COMPLEX</medicinalproduct>
        <drugbatchnumb>C0553</drugbatchnumb>
        <drugdosagetext>33 UNITS PRN IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SKIN WRINKLING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLLAGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518995-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIHISTAMINE THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugindication>INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA FRUIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518996-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>D4A771-D4C4109-D4C052</drugbatchnumb>
        <drugdosagetext>54MG IVSS WEEKLY X3</drugdosagetext>
        <drugindication>NEOPLASM RECURRENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN 3.5MG/M2 - GLAXO SMITHKLINE</medicinalproduct>
        <drugbatchnumb>20248H012</drugbatchnumb>
        <drugdosagetext>6.3MG IVSS WEEKLY  X3</drugdosagetext>
        <drugindication>NEOPLASM RECURRENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN 3.5MG/M2 - GLAXO SMITHKLINE</medicinalproduct>
        <drugbatchnumb>20248H012</drugbatchnumb>
        <drugdosagetext>6.3MG IVSS WEEKLY  X3</drugdosagetext>
        <drugindication>PERITONEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT B12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518997-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200408192</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DROOLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTIONS INVOLUNTARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugindication>FACIAL SPASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>35 UNITS ONCE IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>FACIAL SPASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020228</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>37.5 UNITS ONCE IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>FACIAL SPASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020813</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCYAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONODOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRATEST H.S.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518998-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECONOMIC PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMBLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4518999-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004US001435</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRUXISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADENOSCAN</medicinalproduct>
        <drugauthorizationnumb>20059</drugauthorizationnumb>
        <drugdosagetext>140.00 RK/MIN, TOTAL DOSE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SCAN MYOCARDIAL PERFUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519000-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004US001419</companynumb>
    <primarysource>
      <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>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC PNEUMONIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOOCCLUSIVE LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519001-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004US001420</companynumb>
    <primarysource>
      <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>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC TRAUMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC PNEUMONIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC CANDIDA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICES OESOPHAGEAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOOCCLUSIVE LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519002-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>411 MG IV EVERY OTHER WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519003-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410031</companynumb>
    <primarysource>
      <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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUILLAIN-BARRE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX  COSMETIC</medicinalproduct>
        <drugdosagetext>22 UNITS PRN IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SKIN WRINKLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLU SHOT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519004-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106.5953</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>160MG  WEEKLY  INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LARYNGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>84 MG  WEEKLY INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519005-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0002446</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.0187</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHYOL</medicinalproduct>
        <drugauthorizationnumb>20221</drugauthorizationnumb>
        <drugdosagetext>500 MG, 5 IN 1 WK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHYOL</medicinalproduct>
        <drugauthorizationnumb>20221</drugauthorizationnumb>
        <drugdosagetext>500 MG, 5 IN 1 WK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RADIOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N (PARACETAMOL, DEXTROPROPOXYPHENE NAPSILATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519006-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.3388</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELINGS OF WORTHLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF ESTEEM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEMPLOYMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>30MG  , 1 X DAY  ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519007-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040818</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004230170US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519008-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENITAL BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METROGEL</medicinalproduct>
        <drugdosagetext>5 DAYS</drugdosagetext>
        <drugindication>BACTERIAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METROGEL</medicinalproduct>
        <drugdosagetext>5 DAYS</drugdosagetext>
        <drugindication>VAGINAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519009-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>4 MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>250 MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSCLC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DVT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519010-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44.4525</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>20MG  DAILY OTHER</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>ALCOHOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>20MG  DAILY OTHER</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519011-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.1637</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-SMALL CELL LUNG CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECURRENT CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>40MG  EVERY 2 WKS</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519012-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.7507</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
        <drugbatchnumb>4544</drugbatchnumb>
        <drugdosagetext>3ML  600MG  ONE DOSE ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIAGNOSTIC PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
        <drugbatchnumb>4544</drugbatchnumb>
        <drugdosagetext>3ML  600MG  ONE DOSE ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
        <drugbatchnumb>4544</drugbatchnumb>
        <drugdosagetext>3ML  600MG  ONE DOSE ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL IMPAIRMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519013-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANGLOBULIN</medicinalproduct>
        <drugdosagetext>100 GRAMS IV X 2 DOSES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAEMIA HAEMOLYTIC AUTOIMMUNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANGLOBULIN</medicinalproduct>
        <drugdosagetext>100 GRAMS IV X 2 DOSES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAEMIA HAEMOLYTIC AUTOIMMUNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODOPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519014-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.782</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519015-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519016-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519017-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519018-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.6788</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519019-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519020-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519021-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.5547</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5MG  1 ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL-IPRATROPIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519022-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98.8842</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519023-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RELAFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519024-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>136.0791</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519025-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MACRODANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPICILLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519026-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519027-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519028-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519029-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519030-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02322</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC /FRA/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519031-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02813</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADIZEM-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GTN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519032-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02302</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIPIDS INCREASED</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTORETIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519033-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05895</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UTERINE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
        <drugauthorizationnumb>19726</drugauthorizationnumb>
        <drugdosagetext>20 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugdosagetext>3.6 MG Q4WK SQ</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FURTULON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519034-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AC00641</companynumb>
    <primarysource>
      <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>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPROLACTINAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>200 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>500 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>200 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REDOMEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMPROMEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFORTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX RETARD</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519035-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02522</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.2043</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>600 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>300 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519036-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02737</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL AVOIDANT BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>250 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>15 MG HS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>30 MG HS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519037-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004PK02003</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>100 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519038-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04ITY0254 297</companynumb>
    <primarysource>
      <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>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRASTAT</medicinalproduct>
        <drugauthorizationnumb>20912</drugauthorizationnumb>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRATE-DERIVATIVE (ORGANIC NITRATES)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519039-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1262</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXANTHEM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOFRAN (ONDANSETRON) TABLETS</medicinalproduct>
        <drugdosagetext>4 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040714</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519040-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1017</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAFERONPEG</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519041-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-0883</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTACIN (GENTAMICIN SULFATE) INJECTABLE SOLUTION</medicinalproduct>
        <drugauthorizationnumb>50039</drugauthorizationnumb>
        <drugindication>BLOOD DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519042-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEU-2004-0001129</companynumb>
    <primarysource></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>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MST CONTINUS (MORPHINE SULFATE) CR CAPSULE DAILY</medicinalproduct>
        <drugauthorizationnumb>19516</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OFF LABEL USE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519043-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-2004-035577</companynumb>
    <primarysource>
      <qualification>5</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>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519044-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-2004-034559</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>22424A</drugbatchnumb>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519045-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004075233</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOGORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYME DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROLOGY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>10392</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIMEBUTINE (TRIMEBUTINE)</medicinalproduct>
        <drugdosagetext>600 MG (200 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GELOX (ALUMINIUM HYDROXIDE, ALUMINIUM SILICATE, MAGNESIUM HYDROXIDE)</medicinalproduct>
        <drugdosagetext>(3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>3 GRAM (1 GRAM, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERENOA REPENS (SERENOA REPENS)</medicinalproduct>
        <drugdosagetext>320 MG (160 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519046-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-2004-032794</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>128</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519047-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2004-035478</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IUCD COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>INSERTION UNSUCCESSFUL</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519048-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-2004-035280</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE POLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519049-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2004-034842</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>130</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 300</medicinalproduct>
        <drugbatchnumb>42124A</drugbatchnumb>
        <drugauthorizationnumb>21425</drugauthorizationnumb>
        <drugdosagetext>130 M1, 1 DOSE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM ABDOMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE (ENOXAPARAIN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (POTASSIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORADRENALINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519050-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>T04-SWI-06971-01</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRALEX (ESCITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRALEX (ESCITALOPRAM)</medicinalproduct>
        <drugdosagetext>15 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRALEX (ESCITALOPRAM)</medicinalproduct>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040822</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUXAL (CHLORPROTHIXENE HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>60 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040822</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>0.5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040822</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519051-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-2004-035459</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 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL PRURITUS MALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST/CLAROGRAF (IOPROMIDE)</medicinalproduct>
        <drugauthorizationnumb>20220</drugauthorizationnumb>
        <drugindication>COMPUTERISED TOMOGRAM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519052-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-FRA-07819-02</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPLEX (ESCITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>20 MG QD TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>200 MG QD TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAGID (METFORMIN EMBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDIATOR (BENFLUOREX HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>150 MG QD TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>50 MG QD TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYSANXIA  (PRAZEPAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519053-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-2004-035605</companynumb>
    <primarysource>
      <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>BREAST CANCER IN SITU</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519054-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210536</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AORTIC ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRODUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>522 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN (TAMSULOSIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIANSERIN (MIANSERIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519055-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004PL000072</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BRAIN ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KAPOSI'S SARCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA CYTOMEGALOVIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugauthorizationnumb>16324</drugauthorizationnumb>
        <drugdosagetext>2 MG/KG; DAILY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519056-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-2004-035472</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>MENORRHAGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE (VENLAFAXINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL (CODEINIE PHOSPHATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAHISTINE (BETAHISTINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DANAZOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519057-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05553</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>313 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519058-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02574</companynumb>
    <primarysource>
      <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>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEFITINIB</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519059-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG01253</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEBUTOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATHYMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYTOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519060-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05871</companynumb>
    <primarysource>
      <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>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADENOCARCINOMA OF THE CERVIX</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAI-KENCHU-TO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUZEN-TAIHO-TO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519061-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410414BYL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugauthorizationnumb>19537</drugauthorizationnumb>
        <drugdosagetext>200 MG, TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PL (COUGH AND COLD PREPARATIONS)</medicinalproduct>
        <drugdosagetext>TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOLDA (TRANEXAMIC ACID)</medicinalproduct>
        <drugdosagetext>250 MG, TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAMEZIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519062-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410565BYL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMATOSIS CYSTOIDES INTESTINALIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOBAY</medicinalproduct>
        <drugauthorizationnumb>20482</drugauthorizationnumb>
        <drugdosagetext>100 MG, TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INHIBACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519063-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410605BFR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>130</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOR (ACARBOSE)</medicinalproduct>
        <drugauthorizationnumb>20482</drugauthorizationnumb>
        <drugdosagetext>150 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>300 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EUPRESSYL (URAPIDIL)</medicinalproduct>
        <drugdosagetext>120 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>50 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>30 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519064-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410633BNE</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.3</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>17575</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>17575</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACARBAZINE</medicinalproduct>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-DANTHRAMER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519065-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410848BCA</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 COMPARTMENT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY RELATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN INJECTION (MOXIFLOXACIN)</medicinalproduct>
        <drugauthorizationnumb>21277</drugauthorizationnumb>
        <drugdosagetext>400 MG, TOTAL DAILY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NA BICARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERIDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRESH FROZEN PLASMA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519066-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2004-035515</companynumb>
    <primarysource>
      <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>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519067-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00153</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519068-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE03999</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519069-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040804</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP10358</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BILIARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPULMONARY ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY MYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugdosagetext>20 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030523</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugdosagetext>20 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030527</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030227</drugenddate>
        <drugtreatmentduration>24480</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>1.2 - 2.5 MG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030131</drugenddate>
        <drugtreatmentduration>24480</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>0.5 - 2 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030210</drugenddate>
        <drugtreatmentduration>14400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>0.7 - 3 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030715</drugenddate>
        <drugtreatmentduration>137</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugdosagetext>5 - 100 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>750 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030510</drugenddate>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519070-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05914</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519071-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP14373</companynumb>
    <primarysource>
      <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>GASTRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>150 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519072-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004AR14668</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519073-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05926</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIAL FISTULA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519074-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12657</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519075-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MK200411-0200-1</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTRAST MEDIA REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIRAY 320</medicinalproduct>
        <drugauthorizationnumb>19710</drugauthorizationnumb>
        <drugdosagetext>93 ML, ONCE, IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIVALDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOMINOBEN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTEOLOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTIAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519076-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CA15933</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519077-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15908</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>1</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>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519078-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15901</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VP-16</medicinalproduct>
        <drugdosagetext>60 MG/KG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRRADIATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>L-ASPARAGINASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARA-C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugdosagetext>2 MG/KG/D</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519079-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02274</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugauthorizationnumb>20441</drugauthorizationnumb>
        <drugdosagetext>100 UG QD IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugdosagetext>1.25 MG QD IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONO-TILDIEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519080-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05924</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORNEAL INFILTRATES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519081-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04349</companynumb>
    <primarysource>
      <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>HYPERPROLACTINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYCYSTIC OVARIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugindication>MOOD ALTERED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519082-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041009</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004TR15883</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>200 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
        <drugtreatmentduration>3528</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugdosagetext>5 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugdosagetext>1440 MG/DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugdosagetext>3 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519083-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419054US</companynumb>
    <primarysource>
      <qualification>1</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>KETEK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>SINUSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519084-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414436FR</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL MEGAURETER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOLVULUS OF BOWEL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>ANTIPHOSPHOLIPID SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPEGIC 325</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>ANTIPHOSPHOLIPID SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519085-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414448FR</companynumb>
    <primarysource></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>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROVEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519086-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419157US</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519087-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419179US</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DDAVP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519088-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413662JP</companynumb>
    <primarysource>
      <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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519089-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15899</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
        <drugdosagetext>270 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUITRAN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOZYM</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519091-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12755385</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>LOADING DOSE, 872 MG, D/C ON 03-NOV-04</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519092-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12750352</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>1ST INFUSION, 664 MG; INFUSION STOPPED AFTER 7 MINUTES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANZEMET</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519093-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12768743</companynumb>
    <primarysource>
      <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>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>START DATE:  07-OCT-2004, 14-OCT-2004</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE GEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULCERLMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CABAGIN</medicinalproduct>
        <drugdosagetext>-UO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUNRYTHM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORSENID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519095-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040913</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12700290</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>2ND DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519096-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP03917</companynumb>
    <primarysource>
      <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>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugdosagetext>40 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519097-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12741450</companynumb>
    <primarysource>
      <qualification>3</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>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHLORAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERNATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519098-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12776761</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugindication>HOT FLUSH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HOT FLUSH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>HOT FLUSH</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519099-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12777744</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519100-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413116GDS</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>400 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACC LONG (ACETYLCYSTEINE0</medicinalproduct>
        <drugdosagetext>600 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIKREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519102-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02286</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAROXYL</medicinalproduct>
        <drugdosagetext>75 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
        <drugdosagetext>1 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>3 G QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SKENAN</medicinalproduct>
        <drugdosagetext>30 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519103-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040820</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12679353</companynumb>
    <primarysource>
      <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>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUNGIZONE</medicinalproduct>
        <drugdosagetext>DOSE RANGE FROM 10-30 MG PER DAY; 3 COFFEESPOONS ORAL SUSPENSION 07-MAY- TO 31-MAY-2004</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040527</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>DOSES RANGING FROM 750 MG TO 1.5 GRAM</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040527</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OROKEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040529</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040604</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELITREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040530</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPALGIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIENAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLITICAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAVEDOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARACYTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519104-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12776811</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519105-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE650908OCT04</companynumb>
    <primarysource>
      <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>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE EVERY OTHER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE AND FREQUENCY</drugdosagetext>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519106-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413241GDS</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HCL</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>400 MG,TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519107-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-AMGEN-UK100802</companynumb>
    <primarysource>
      <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>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLEOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519108-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200420331GDDC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519109-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200420335GDDC</companynumb>
    <primarysource></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>INDAPAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519110-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200420337GDDC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519111-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200420357GDDC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519112-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200420183GDDC</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEMASTINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519113-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200418619US</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN EXPECTORANT W/ CODEINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519114-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413472JP</companynumb>
    <primarysource>
      <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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040828</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYORIN AP 2</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519115-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413363JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>30</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ALKALOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INADEQUATE DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KORAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEILAX</medicinalproduct>
        <drugdosagetext>DOSE: 1 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEILAX</medicinalproduct>
        <drugdosagetext>DOSE: 1 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVOUSNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PUBLONE S</medicinalproduct>
        <drugdosagetext>DOSE: 6 TABLETS/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519116-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413257JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </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>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RENAL FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMELIAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D ALFA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE-A</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE-A</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519117-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413257GDS</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21277</drugauthorizationnumb>
        <drugdosagetext>400 MG , TOTAL DAILY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugdosagetext>400 MG , TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERFALGAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519118-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20051115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02280</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH VESICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KARDEGIC/FRA/</medicinalproduct>
        <drugdosagetext>1 DF QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>1 DF QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVATREX ^LEDERLE^</medicinalproduct>
        <drugdosagetext>7.5 MG WEEK PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519119-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE234725NOV04</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIGMOIDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519120-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE211418NOV04</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>25MG FREQUENCY UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>200MG FREQUENCY UNSPECIFIED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519121-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE103912OCT04</companynumb>
    <primarysource>
      <qualification>2</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>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519122-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05458</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519123-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE230524NOV04</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BRAIN STEM INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519124-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE234625NOV04</companynumb>
    <primarysource>
      <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>EPIDURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSOAS ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519125-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041200407</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ANGER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519126-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041200421</companynumb>
    <primarysource>
      <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 CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</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>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519127-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041200490</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>10- 15 MG DAILY DOSE</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPLICONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519128-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041200531</companynumb>
    <primarysource>
      <qualification>1</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>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519129-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02336</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QRS COMPLEX PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCAPNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugdosagetext>40 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>5 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFU K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STABLON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519130-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE06501</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OTHER DRUGS NOT SPECIFIED</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519131-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12773560</companynumb>
    <primarysource>
      <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>CATATONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCYCLIDINE HYDROCHLORIDE 2MG TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EXTRAPYRAMIDAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519132-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040816</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12672713</companynumb>
    <primarysource>
      <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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040809</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040809</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM ALGINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040814</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519133-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105794</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.48</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETERIC OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519134-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041006093</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATRECOR</medicinalproduct>
        <drugdosagetext>CONTINUOUS INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATRECOR</medicinalproduct>
        <drugdosagetext>CONTINUOUS INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATRECOR</medicinalproduct>
        <drugdosagetext>BOLUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYUREA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYUREA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>500-1000 MG</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
        <drugdosagetext>2 UNITS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
        <drugdosagetext>2 UNITS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE CALCIUM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>2-6 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugdosagetext>3000 UNITS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugdosagetext>3000 UNITS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugdosagetext>4000 UNITS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugdosagetext>3000 UNITS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
        <drugdosagetext>1 UNIT</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PALLIATIVE CARE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugdosagetext>ATROPINE 1% DROPS, 2 DROPS</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>PALLIATIVE CARE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugdosagetext>1-3 L/MIN</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>3-18 UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519135-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG01784</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORIMOTOR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCAINE</medicinalproduct>
        <drugauthorizationnumb>71202</drugauthorizationnumb>
        <drugdosagetext>17.5 MG ONCE IT</drugdosagetext>
        <drugadministrationroute>038</drugadministrationroute>
        <drugindication>SPINAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040212</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519137-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02743</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP WALKING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugdosagetext>1 DF QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519139-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041106847</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519140-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041106364</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519141-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041106744</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugdosagetext>THREE 100 UG/HR PATCHES (PATIENT CHANGES ONE 100 UG/HR PATCH EACH DAY).</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>THERAPEUTIC RESPONSE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519142-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041200160</companynumb>
    <primarysource>
      <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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519143-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041200293</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL DISABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0327294</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519144-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041200316</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPHANE INSULIN</medicinalproduct>
        <drugdosagetext>X 30 YEARS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugdosagetext>AT BEDTIME 3 TO 4 TIMES A MONTH</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519145-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20041100128</companynumb>
    <primarysource>
      <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>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519146-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02087</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>124</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
        <drugauthorizationnumb>17970</drugauthorizationnumb>
        <drugdosagetext>809 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040818</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519147-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041106292</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519148-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410322</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
        <drugauthorizationnumb>21275</drugauthorizationnumb>
        <drugindication>OPEN ANGLE GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519149-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-UK098182</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANISOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POIKILOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN INTRAVENOUS (HUMAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIFEDIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519150-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP02127</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCAINE</medicinalproduct>
        <drugauthorizationnumb>18304</drugauthorizationnumb>
        <drugindication>DENTAL TREATMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCAINE</medicinalproduct>
        <drugindication>DENTAL TREATMENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519151-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12779138</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>INITIAL TX DATE: 17-SEP-04. 1932MG IS TOTAL DOSE ADM THIS COURSE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>INITIAL TX DATE: 17-SEP-04. 136MG TOTAL DOSE ADM THIS COURSE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugdosagetext>INITIAL TX DATE: 17-SEP-04. 174 MG TOTAL DOSE ADM THIS COURSE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN</medicinalproduct>
        <drugdosagetext>TOTAL DOSE ADM THIS COURSE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519152-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040804</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-12661120</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>INITIAL TX DATE: 18-JUN-04. PT REC'D 7 DOSES AT THE TIME OF THE EVENT.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugdosagetext>PRE-2001.</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCAINE</medicinalproduct>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040730</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519153-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-385208</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040925</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040926</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519154-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05929</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SELOKEN</medicinalproduct>
        <drugauthorizationnumb>50706</drugauthorizationnumb>
        <drugdosagetext> 60 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SELOKEN</medicinalproduct>
        <drugauthorizationnumb>50706</drugauthorizationnumb>
        <drugdosagetext> 60 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TACHYARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugdosagetext>60 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugdosagetext>60 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TACHYARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHIMAZOLE</medicinalproduct>
        <drugdosagetext>80 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugdosagetext>1 G DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519155-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ROCHE-383534</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040612</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040605</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040610</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040605</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODEOXYCHOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALGANCICLOVIR</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM-SULFAMETHOXAZOLE</medicinalproduct>
        <drugindication>ANTIBACTERIAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040618</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519156-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-386289</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA-2A</medicinalproduct>
        <drugdosagetext>6 MILLIONU/M2 ONCE A WEEK ON WEEK ONE+ FOUR AND THRICE WEEKLY ON WEEK 2 + 3.  CUMULATIVE DO+</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA-2A</medicinalproduct>
        <drugdosagetext>6 MILLIONU/M2 ONCE A WEEK ON WEEK ONE+ FOUR AND THRICE WEEKLY ON WEEK 2 + 3.  CUMULATIVE DO+</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERLEUKIN-2</medicinalproduct>
        <drugdosagetext>10 MILLIONU/M2 ON DAY THREE FOR THREE DAYS ON WEEK 1 + 4 AND 5MILLIONU/M2 THRICE WEEKLY ON WEEK+</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERLEUKIN-2</medicinalproduct>
        <drugdosagetext>10 MILLIONU/M2 ON DAY THREE FOR THREE DAYS ON WEEK 1 + 4 AND 5MILLIONU/M2 THRICE WEEKLY ON WEEK+</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519157-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030415</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-336268</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALLERGY TO CHEMICALS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN INTRACRANIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</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</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEARNING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNORING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugdosagetext>DOSAGE WAS 40MG EVERY DAY FROM 01JUN1999 TO AN UNKNOWN DATE IN JUNE 1999.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugdosagetext>ON AN UNKNOWN DATE IN JUNE 1999 THE DOSE WAS LOWERED TO 20MG EVERY DAY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN-D</medicinalproduct>
        <drugdosagetext>START DATE NOT PROVIDED AND DOSAGE REGIMEN IS REPORTED TO BE TAKEN EVERY DAY (QD).</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519158-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410323</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
        <drugauthorizationnumb>21275</drugauthorizationnumb>
        <drugindication>OPEN ANGLE GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519159-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02810</companynumb>
    <primarysource></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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED CELL DISTRIBUTION WIDTH ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugauthorizationnumb>18240</drugauthorizationnumb>
        <drugdosagetext>25 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519160-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02313</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugauthorizationnumb>19777</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1000 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE</medicinalproduct>
        <drugdosagetext>4 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOTHIEPIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519161-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05457</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG QOD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG QOD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519162-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210683</companynumb>
    <primarysource>
      <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>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>150 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519163-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP03363</companynumb>
    <primarysource></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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519164-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004PL000070</companynumb>
    <primarysource>
      <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>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugauthorizationnumb>16324</drugauthorizationnumb>
        <drugdosagetext>75 MG; DAILY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519165-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02315</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519166-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6011687F</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL SENSATION IN EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
        <drugdosagetext>1000 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519167-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-368919</companynumb>
    <primarysource>
      <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>ASTHENOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
        <drugtreatmentduration>168</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
        <drugtreatmentduration>166</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>DOSING REGIMEN REPORTED AS 5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519168-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ROCHE-386107</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040912</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519169-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-387106</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CERVIX CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519170-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-387358</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519171-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-10879</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS FOCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</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>20011101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519172-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ROCHE-387317</companynumb>
    <primarysource>
      <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>PYOGENIC GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTAN</medicinalproduct>
        <drugdosagetext>STRENGTH STATED AS 10MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTAN</medicinalproduct>
        <drugdosagetext>STRENGTH STATED AS 20MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTAN</medicinalproduct>
        <drugdosagetext>STRENGTH STATED AS 20MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040620</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTAN</medicinalproduct>
        <drugdosagetext>STRENGTH STATED AS 20MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519173-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-387682</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECORTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOCOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-THYROXINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REDUCTO-SPEZIAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM D.S.</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYMYCARD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519174-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-NOR-07820-01</companynumb>
    <primarysource>
      <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>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EBIXA (MEMANTINE)</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAREVAN ^BRITISH DRUG HOUSES^(WAFARIN SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519175-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ROCHE-387692</companynumb>
    <primarysource>
      <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>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TICLID</medicinalproduct>
        <drugdosagetext>SECONDARY REPORTED INDICATION: CORONARY STENT PLACEMENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA BLOCKERS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACE INHIBITORS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519176-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-387585</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041010</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOCIN HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELISOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040925</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARGOCID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FONZYLANE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMIX</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JOSIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519177-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ROCHE-387541</companynumb>
    <primarysource>
      <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>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>DOSAGE ADJUSTED TO REACH PREDEFINED TARGET LEVELS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041127</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041128</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>DOSAGE TAPERED ACCORDING TO LOCAL PROTOCOL.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOTAXIM</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLINE</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOBRAMYCIN</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMFOTERICINE B</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATINE</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUMSULFAT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOORHEXIDINEDIGLUCONAAT</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARINE</medicinalproduct>
        <drugindication>DEEP VENOUS THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUMCHLORID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUMGLUCONAT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOL</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519178-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RENA-11186</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DESQUAMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugauthorizationnumb>21179</drugauthorizationnumb>
        <drugdosagetext>0.25 G TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEZAFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBROXOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN ALFA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519179-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ROCHE-387961</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>170</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519180-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-FRA-06108-01</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>10 MG BID PO</drugdosagetext>
        <drugadministrationroute>046</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugdosagetext>1 QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>2 MG QOD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>1 MG QOD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATINE (PRAVASTATIN)</medicinalproduct>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMAN PROTHROMBIN COMPLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANNITOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAHISTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL (PERINDOPRIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519181-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-387798</companynumb>
    <primarysource>
      <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>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GANCICLOVIR SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040317</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040320</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINIPRESS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXOLON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519182-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-388074</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011106</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519183-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA04066</companynumb>
    <primarysource>
      <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>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOCYSTEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBROXOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUANABENZ ACETATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519184-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05894</companynumb>
    <primarysource>
      <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>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugauthorizationnumb>20498</drugauthorizationnumb>
        <drugdosagetext>80 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519185-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-0410ESP00015</companynumb>
    <primarysource>
      <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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLEX PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519186-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-FRA-07473-01</companynumb>
    <primarysource>
      <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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEREOTYPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</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>20040710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MODOPAR</medicinalproduct>
        <drugindication>CATATONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDALIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE/FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMACOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519187-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE06488</companynumb>
    <primarysource>
      <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>ANTICONVULSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND HCT</medicinalproduct>
        <drugauthorizationnumb>21093</drugauthorizationnumb>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>200 MG BID</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519188-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-FRA-07681-01</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPRAM (CITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EQUANIL</medicinalproduct>
        <drugdosagetext>400 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATHYMIL (MIANSERIN HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>30 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519189-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-FRA-07817-01</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPRAM (CITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THERALENE (ALIMEMAZINE TARTRATE)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040702</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519190-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02328</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIDURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUNCTURE SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMLA</medicinalproduct>
        <drugauthorizationnumb>19941</drugauthorizationnumb>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETADINE</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519191-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AC00814</companynumb>
    <primarysource></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>JOINT CREPITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>20578</drugauthorizationnumb>
        <drugdosagetext>10.8 MG ONCE SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVIAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519192-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096615</companynumb>
    <primarysource></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>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugauthorizationnumb>19885</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG 1 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519193-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096121</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>AKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATATONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREEZING PHENOMENON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL EXAMINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DELAYED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCYCLIDINE HYDROCHLORIDE 2MG TAB</medicinalproduct>
        <drugdosagetext>10 MG (5 MG  2 IN 1 D</drugdosagetext>
        <drugindication>AKINESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519194-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP04749</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHIOLOALVEOLAR CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHIOLOALVEOLAR CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOSHAJINKIGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HONKUNALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAIXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAZUCROSS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519195-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0411GBR00243</companynumb>
    <primarysource>
      <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>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519196-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA02377</companynumb>
    <primarysource>
      <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>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>KNEE ARTHROPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIP ARTHROPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519197-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00002</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519198-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0407USA01651</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugbatchnumb>P7141</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040711</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519199-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP04318</companynumb>
    <primarysource></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>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>20541</drugauthorizationnumb>
        <drugdosagetext>1 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519200-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00012</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLANK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031130</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519201-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210744</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>2 MG/KG INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINORELBINE TARTRATE</medicinalproduct>
        <drugdosagetext>25MG/KG INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519202-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA02454</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040331</drugenddate>
        <drugtreatmentduration>623</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</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>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519203-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04078</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORIDEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519204-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0411CAN00227</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERAL SYMPTOM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519205-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004JP15278</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.013</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISUDYNE</medicinalproduct>
        <drugauthorizationnumb>21119</drugauthorizationnumb>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADONA (AC-17)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARIKUROMONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519206-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03557</companynumb>
    <primarysource>
      <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC GRANULOMATOUS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOCET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519207-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02272</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugdosagetext>1 DF QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>850 MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040721</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519208-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04151</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519209-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00258</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519210-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03864</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519211-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210758</companynumb>
    <primarysource>
      <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 ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>4MG/KG SINGLE INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>960 MG INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>62.5 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>950 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519212-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0412USA00281</companynumb>
    <primarysource>
      <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>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>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519213-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0409USA00308</companynumb>
    <primarysource>
      <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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519214-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE06435</companynumb>
    <primarysource></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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugdosagetext>4 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>8 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULINS AND ANALOGUES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519215-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-MERCK-0411TWN00017</companynumb>
    <primarysource>
      <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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519216-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004JP16330</companynumb>
    <primarysource>
      <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>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISUDYNE</medicinalproduct>
        <drugauthorizationnumb>21119</drugauthorizationnumb>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519217-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AC00795</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
        <drugauthorizationnumb>20746</drugauthorizationnumb>
        <drugdosagetext>64 UG BID IN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519218-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8008131</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>35.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BELLIGERENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>250 MG 1/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIVALPROEX SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARNITINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMAN INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519219-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0409USA01845</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>105</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519220-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA01683</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NECROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROITIN SULFATE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINSEED OIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B (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)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519221-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8008136</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIAPHRAGMATIC APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPITOMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519222-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0412CAN00017</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519223-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12405718</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX EC</medicinalproduct>
        <drugbatchnumb>MEE87</drugbatchnumb>
        <drugdosagetext>8 TO 10 YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519224-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8008133</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>250MG/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>250MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPILIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOABZAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SABRIL</medicinalproduct>
        <drugadministrationroute>023</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519225-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12419693</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX EC</medicinalproduct>
        <drugdosagetext>THERAPY INTERRUPTED 10/27/2003</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519226-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031204</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12451878</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX EC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519227-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040226</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12517918</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX EC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040205</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519228-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040506</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12587317</companynumb>
    <primarysource>
      <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>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010620</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>400/100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519229-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040609</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12633616</companynumb>
    <primarysource>
      <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>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</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>LOPINAVIR + RITONAVIR</medicinalproduct>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
        <drugindication>KAPOSI'S SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDINAVIR</medicinalproduct>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519230-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040609</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12633640</companynumb>
    <primarysource>
      <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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR SULFATE+ZIDOVUDINE+LAMIVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519231-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12645032</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX EC</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>4519232-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12668067</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519233-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12688404</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519234-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02279</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MODOPAR</medicinalproduct>
        <drugdosagetext> 50 MG + 12.5 MG BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>0.25 DF QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugdosagetext>0.2 MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CREON ^DUPHAR^</medicinalproduct>
        <drugdosagetext>25000 U TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519235-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12700563</companynumb>
    <primarysource>
      <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 CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX EC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519236-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12704557</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519237-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12744801</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX EC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519238-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410582BYL</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOBAY</medicinalproduct>
        <drugauthorizationnumb>20482</drugauthorizationnumb>
        <drugdosagetext>100 MG TID ORAL; 300 MG TOTAL DAILY ORAL; 300 MG TOTAL DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOBAY</medicinalproduct>
        <drugauthorizationnumb>20482</drugauthorizationnumb>
        <drugdosagetext>100 MG TID ORAL; 300 MG TOTAL DAILY ORAL; 300 MG TOTAL DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOBAY</medicinalproduct>
        <drugauthorizationnumb>20482</drugauthorizationnumb>
        <drugdosagetext>100 MG TID ORAL; 300 MG TOTAL DAILY ORAL; 300 MG TOTAL DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG OM ORAL; 10 MG TOTAL DAILY ORAL; 10 MG TOTAL DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG OM ORAL; 10 MG TOTAL DAILY ORAL; 10 MG TOTAL DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG OM ORAL; 10 MG TOTAL DAILY ORAL; 10 MG TOTAL DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIALLERGIC AGENTS (DECONGESTANTS AND ANTIALLERGICS)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACINON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519239-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8008072</companynumb>
    <primarysource>
      <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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL CONVULSIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>2000 MG/D</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>2000MG/D</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRMATE</medicinalproduct>
        <drugdosagetext>100MG/D</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRMATE</medicinalproduct>
        <drugdosagetext>100MG/D</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519240-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8008053</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENURESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS A</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBOTHROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEARFULNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>3000MG/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYLEPSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYTIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELOC ZOK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XIMOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519241-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG01920</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IKOREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519242-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8006872</companynumb>
    <primarysource>
      <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>PLACENTAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>2000MG/D VIA</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519243-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8006421</companynumb>
    <primarysource>
      <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>ALPHA 1 FOETOPROTEIN AMNIOTIC FLUID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOBACCO ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULTRASOUND SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>2000MG/D</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>3000MG/D</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519244-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004012638</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>21267</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, 2IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFUROXIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE (BUDESONIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM (MEROPENEM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519245-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004US001360</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTOPIC</medicinalproduct>
        <drugauthorizationnumb>50777</drugauthorizationnumb>
        <drugdosagetext>TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAMIDINE (PENTAMIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCILOVIR (GANCICLOVIR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM (MEROPENEM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519246-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004JP002035</companynumb>
    <primarysource>
      <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>B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN HERNIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL TOXOPLASMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANT SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS ANTIGEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugindication>BONE MARROW TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519247-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004049128</companynumb>
    <primarysource>
      <qualification>3</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>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>10 MG (5 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugdosagetext>5 MG (5 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugdosagetext>5 MG (5 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>50 MG (25 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBON COMPOUND (BELLADONNA EXTRACT, CHARCOAL, ACTIVATED, MAGNESIUM HY</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBON COMPOUND (BELLADONNA EXTRACT, CHARCOAL, ACTIVATED, MAGNESIUM HY</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>0.2 MG (0.2 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALOSEN (ACHILLEA, RUBIA ROOT TINCTURE, SENNA FRUIT, SENNA LEAF, TARAXA</medicinalproduct>
        <drugdosagetext>1.5 GRAM (1.5 GRAM, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LAXATIVE SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519248-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004JP002037</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>3.00MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE MARROW TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519251-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004067452</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERINFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERINFECTION LUNG</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519253-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004024794</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
        <drugauthorizationnumb>19885</drugauthorizationnumb>
        <drugdosagetext>40 MG (20 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID (ACTEYLSALICYLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519254-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004082765</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>2.5 MG (2.5 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519255-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004080035</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDURA XL</medicinalproduct>
        <drugauthorizationnumb>19668</drugauthorizationnumb>
        <drugdosagetext>4 MG (4 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040925</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519256-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004086577</companynumb>
    <primarysource>
      <qualification>2</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>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugbatchnumb>4007802</drugbatchnumb>
        <drugauthorizationnumb>19950</drugauthorizationnumb>
        <drugdosagetext>(1 IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519257-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004079230</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELDOX</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE (QUETIAPINE FUMARATE)</medicinalproduct>
        <drugdosagetext>600 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL PREPARATION (HERBAL PREPARATION)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519258-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004094888</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPERAZON (SULBACTAM, CEFOPERAZONE)</medicinalproduct>
        <drugauthorizationnumb>50551</drugauthorizationnumb>
        <drugdosagetext>(1D)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519259-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ST-2004-008143</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE IMMEASURABLE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugauthorizationnumb>21286</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RINPRAL</medicinalproduct>
        <drugdosagetext>50 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYCOBIDE</medicinalproduct>
        <drugdosagetext>0.5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519260-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096972</companynumb>
    <primarysource>
      <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>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
        <drugauthorizationnumb>19885</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYMETAZOLINE (OXYMETAZOLINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519261-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SP-2004-001949</companynumb>
    <primarysource>
      <qualification>1</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugauthorizationnumb>21286</drugauthorizationnumb>
        <drugdosagetext>40 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519262-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004084094</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>37.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>50670</drugauthorizationnumb>
        <drugdosagetext>( 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METILDIGOXIN (METILDIGOXIN)</medicinalproduct>
        <drugdosagetext>0.025 MG (0.025 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVELAMER HYDROCHLORIDE (SEVELAMER HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEPRENONE (TEPRENONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA LEAF (SENNA LEAF)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCAINAMIDE HYDROCHLORIDE (PROCAINAMIDE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN BETA (EPOETIN BETA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519263-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>240652</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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROFEM        (ESTRADIOL HEMIHYDRATE)</medicinalproduct>
        <drugauthorizationnumb>40312</drugauthorizationnumb>
        <drugdosagetext>1 MG, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519264-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096042</companynumb>
    <primarysource>
      <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>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL VOLUME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugauthorizationnumb>21267</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ASPERGILLOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugdosagetext>150 MG (50 MG, 3 IN 1 D)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>AS NECESSARY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>10 MG (1 D)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOSULEPIN</medicinalproduct>
        <drugdosagetext>100 MG (100 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519265-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004043709</companynumb>
    <primarysource>
      <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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE CONTRACTIONS DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POSTPARTUM DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519266-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RS004703-J</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOSCOPY UPPER GASTROINTESTINAL TRACT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCHROMIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA (FERROUS CITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANIRAPID (METILDIGOXIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLUTAL (BLUTAL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALOMIDE (COBAMAMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERO-GRADUMET (FERROUS SULFATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519267-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004094094</companynumb>
    <primarysource>
      <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>COLITIS MICROSCOPIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMORAL NECK FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOXACILLIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519268-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004092576</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>50693</drugauthorizationnumb>
        <drugdosagetext>1000 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URETHRITIS CHLAMYDIAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519269-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12776670</companynumb>
    <primarysource>
      <qualification>3</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>QUESTRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519270-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040906</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12700084</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS BILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORTICOLLIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMOCRIPTINE MESYLATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519271-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12728242</companynumb>
    <primarysource>
      <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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS BILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORTICOLLIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMOCRIPTINE MESYLATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519272-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097409</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519273-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12776779</companynumb>
    <primarysource>
      <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>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040417</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040418</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOCILLINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040417</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519274-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12774741</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM DISCOLOURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIKLIN</medicinalproduct>
        <drugindication>BACTERIAL CULTURE POSITIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040810</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTUM</medicinalproduct>
        <drugindication>BACTERIAL CULTURE POSITIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040810</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORELOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACTERIAL CULTURE POSITIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040814</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040814</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040814</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBROXOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ART 50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANAKAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519275-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004238942JP</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>38</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKODERMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN (SOMATROPIN)</medicinalproduct>
        <drugauthorizationnumb>20280</drugauthorizationnumb>
        <drugdosagetext>(1.2 MG, ONCE DAILY), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTOBACILLUS BIFIDUS, LYOPHILIZED (LACTOBACILLUS BIFIDUS, LYOPHILIZED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA LEAF (SENNA LEAF)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN (BACILLUS SUBTILIS, LACTOBACILLUS ACIDOPHILUS, STREPTOCOCCUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN BETA (EPOETIN BETA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519276-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12751251</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOSPADIAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOMID</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519277-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12769550</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugbatchnumb>03C00824A</drugbatchnumb>
        <drugdosagetext>THIS WAS PT'S FIRST DOSE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>THIS WAS PT'S FIRST DOSE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugdosagetext>THIS WAS PT'S FIRST DOSE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>ATHEROSCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugindication>PAIN PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519278-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003145506CA</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.22</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVIX CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALITOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMENSTRUAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMEAR CERVIX ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON (IRON)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519279-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004055784</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</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 CREATINE PHOSPHOKINASE MB INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMYALGIA RHEUMATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN T INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORTIS (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIPID METABOLISM DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENPROCOUMON (PHENPROCOUMON)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519280-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004241256AU</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugdosagetext>4 MG/DAY (2 MG, BID), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRIOL (ESTRIOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTAZOLINE (ANTAZOLINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE (CLOTRIMAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORAMPENICOL (CHLORAMPENICOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEBEVERINE HYDROCHLORIDE (MEBEVERINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE DIPROPIONATE (BETAMETHASONE DIPROPIONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON LIQUID ^FERRING^ (ALUMINIUM HYDROXIDE, CALCIUM CARBONATE, SOD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE HEMIHYDRATE (INDAPAMIDE HEMIHYDRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE (ESOMEPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARMELLOSE SODIUM (CARMELLOSE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URAL (CITRIC ACID, SODIUM BICARBONATE, SODIUM CITRATE, TARTARIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFUENZA VIRUS VACCINE POLYVALENT (INFLUENZA VIRUS VACCINE POLYVALENT)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519281-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12741617</companynumb>
    <primarysource>
      <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>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHAMPHETAMINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519282-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004095797</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.5953</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXIDEX (BENZALKONIUM CHLORIDE, DEXAMETHASONE, PHENYLMERCURIC NITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAMZOLAM (ALPRAZOLAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519283-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12784500</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519284-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096215</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIL (EXEMESTANE)</medicinalproduct>
        <drugauthorizationnumb>20753</drugauthorizationnumb>
        <drugdosagetext>25 MG (25 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519285-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0414361A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPRISONMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPULSIVE BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011029</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519286-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096018</companynumb>
    <primarysource></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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021030</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519287-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040715</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0518711A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACANTHAMOEBA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY CORNEAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>KERATITIS HERPETIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040702</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519288-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040805</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0521100A</companynumb>
    <primarysource>
      <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>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGRAPHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUMBLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519289-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096021</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>NERVE INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519290-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0530659A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519291-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0531574A</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519292-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096034</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISTARIL</medicinalproduct>
        <drugauthorizationnumb>11111</drugauthorizationnumb>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOROLAC TROMETHAMINE</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM CITRATE (MAGNESIUM CITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOLYTELY (MACROGOL, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISICOL (SODIUM PHOSPHATE DIBASIC, SODIUM PHOSPHATE MONOBASIC (MONOHYD</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519293-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0532010A</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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519294-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0533762A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</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>4519295-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0534129A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>1G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>240MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>1MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>20MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519296-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0534473A</companynumb>
    <primarysource>
      <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>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugdosagetext>2.5MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANDIN</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>FERROUS SULFATE TAB</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>ATROVENT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</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>MULTI-VITAMIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519297-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004094373</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL SEPTUM DEVIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL AVOIDANT BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519298-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096810</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugbatchnumb>49MAR</drugbatchnumb>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>4 + 8 + 12MG (4 MG, INTERVAL QD/BD/TID ORAL) - SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE (ACETYLSALICYCLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON (IRON)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIRFEROL (EROGOCALCIFEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS CONJUGATED 9ESTROGENS CONJUGATED)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519299-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535383A</companynumb>
    <primarysource>
      <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>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519300-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535398A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519301-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535434A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF LIBIDO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugdosagetext>25MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519302-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535780A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>122.7</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMADEX</medicinalproduct>
        <drugdosagetext>20MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>80MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519303-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0535920A</companynumb>
    <primarysource>
      <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>AVANDIA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519304-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19920330</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-B0157007A</companynumb>
    <primarysource>
      <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>ASTERIXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
        <drugdosagetext>6G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CELLULITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519305-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19950324</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-B0184075A</companynumb>
    <primarysource>
      <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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC INDUCED ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
        <drugdosagetext>2G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
        <drugdosagetext>1.5G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519306-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040924</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-GLAXOSMITHKLINE-B0346623A</companynumb>
    <primarysource>
      <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>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>1.2G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CELLULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040719</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOXAPEN</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CELLULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040719</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTORETIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW FORTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519307-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0357159A</companynumb>
    <primarysource>
      <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>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST NEGATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugdosagetext>800MG FIVE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519308-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0357462A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRYPTANOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519309-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0357889A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B VIRUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519310-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>12459368</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030821</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040402</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519311-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GLAXOSMITHKLINE-B0358100A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUMATRIPTAN SUCCINATE</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERCILON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519313-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0358360A</companynumb>
    <primarysource>
      <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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSTHYMIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXINE NATIVELLE</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROVEL</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519314-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0358379A</companynumb>
    <primarysource>
      <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>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HENOCH-SCHONLEIN PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TINELAC</medicinalproduct>
        <drugdosagetext>4UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEILAX</medicinalproduct>
        <drugdosagetext>1MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENIRAN</medicinalproduct>
        <drugdosagetext>2MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANCOLON</medicinalproduct>
        <drugdosagetext>1UNIT THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910816</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519316-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0358394A</companynumb>
    <primarysource>
      <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 CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELZIR</medicinalproduct>
        <drugdosagetext>700MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugdosagetext>100MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CRYPTOCOCCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519317-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0358402A</companynumb>
    <primarysource>
      <qualification>5</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugdosagetext>150MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugdosagetext>100MCG PER DAY</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>100MCG PER DAY</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519318-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0358404A</companynumb>
    <primarysource>
      <qualification>5</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugdosagetext>100MCG UNKNOWN</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>100MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>100MCG PER DAY</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519319-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0358604A</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519320-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>52004GB03330</companynumb>
    <primarysource>
      <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>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>1200MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>800MG UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugdosagetext>60MG UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPIRIDE</medicinalproduct>
        <drugdosagetext>6400MG UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugdosagetext>600MG UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>100MG UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACAMPROSATE</medicinalproduct>
        <drugdosagetext>7900MG UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>2700MG UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519321-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0358643A</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>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519322-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0358719A</companynumb>
    <primarysource>
      <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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD AVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugdosagetext>10DROP PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
        <drugdosagetext>75MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPROFENID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519323-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-GLAXOSMITHKLINE-B0358858A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZINACEF</medicinalproduct>
        <drugdosagetext>750MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESMERON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFEDRIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFORTIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519324-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-GLAXOSMITHKLINE-B0358859A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>27</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZINACEF</medicinalproduct>
        <drugbatchnumb>4079</drugbatchnumb>
        <drugdosagetext>750MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAVAMED</medicinalproduct>
        <drugdosagetext>750MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519325-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GLAXOSMITHKLINE-B0358860A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>625MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPIDIDYMITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLON</medicinalproduct>
        <drugdosagetext>7.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>10MG WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519326-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-GLAXOSMITHKLINE-B0358862A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ABDOMINAL INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519327-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GLAXOSMITHKLINE-B0358875A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>99</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTIC ACID DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugdosagetext>125MCG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOTEN</medicinalproduct>
        <drugdosagetext>50MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRITACE</medicinalproduct>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519328-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-GLAXOSMITHKLINE-B0358892A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPTODIN</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519330-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GLAXOSMITHKLINE-B0358893A</companynumb>
    <primarysource>
      <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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519331-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0358923A</companynumb>
    <primarysource>
      <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>PAXIL</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIMAS</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519332-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GLAXOSMITHKLINE-B0358953A</companynumb>
    <primarysource>
      <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>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519333-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GLAXOSMITHKLINE-B0358987A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ATROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMIGRAN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519334-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GLAXOSMITHKLINE-B0358995A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAZE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519335-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1262</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXANTHEM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugdosagetext>285MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>97</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519336-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040708</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0044196A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519337-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040901</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0044604A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010614</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010614</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519338-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0045288A</companynumb>
    <primarysource>
      <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>BLADDER CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGUS STOOL IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGUS URINE TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIANI FORTE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugdosagetext>300MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMNIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM VERLA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACC</medicinalproduct>
        <drugdosagetext>600MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519339-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0045366A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519340-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>240493</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID CHU          (INSULIN ASPART)</medicinalproduct>
        <drugauthorizationnumb>20986</drugauthorizationnumb>
        <drugdosagetext>24IU, QD</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLITA (ELECTROLYTES NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOTONIC SOLUTIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519341-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12774923</companynumb>
    <primarysource>
      <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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
        <drugdosagetext>INITIATED DURING THE ^LAST PART OF APRIL 2000^</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519346-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097772</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.2043</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
        <drugauthorizationnumb>20607</drugauthorizationnumb>
        <drugdosagetext>150 MG (75 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519347-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A044-002-005149</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</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</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC (DICLOFENAC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED ANTI-HYPERTENSIVE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519348-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004240755US</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>(1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>(1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TENDONITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>(1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>(1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TENDONITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519349-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A044-002-005324</companynumb>
    <primarysource>
      <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>HAEMATEMESIS</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>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519350-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097796</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOULDER ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, QD INTERVAL:  EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519351-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004092542</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>4570</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTEASE (PROTEASE)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519352-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>J081-002-001798</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCREATININAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUP-4 (PROPIVERINE HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>60 MG, 3 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVISHOT (NAFTOPIDIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519353-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097721</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040629</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519354-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097758</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.2658</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NON-CARDIOGENIC PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESLORATADINE (DESLORATADINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM (ESCITALOPRAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIM HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAFIRLUKAST (ZAFIRLUKAST)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519355-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D01200404605</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51.7</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QRS AXIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL CELL LUNG CANCER EXTENSIVE STAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>74735</drugauthorizationnumb>
        <drugdosagetext>80 MG/M2 CONT- INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER EXTENSIVE STAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>120 MG/M2 GIVE ON DAYS 1, 2, AND 3, IN A 30-MINUTE INFUSION - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER EXTENSIVE STAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPARTROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN/CLAUVLANCE ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN HUMAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN INITARD NORDISK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORDIAZEPOXIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519356-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097601</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>(300 MG)</drugdosagetext>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>(500 MG)</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE (HYDROCODONE)</medicinalproduct>
        <drugdosagetext>(500 MG)</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519357-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004234382US</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519358-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D01200404425</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISLPATIN</medicinalproduct>
        <drugauthorizationnumb>74735</drugauthorizationnumb>
        <drugdosagetext>80MG/M2 CONT - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER EXTENSIVE STAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>120 MG/M2 GIVEN ON DAYS, 1, 2 AND 3, IN A 30-MINUTE INFUSION - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER EXTENSIVE STAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519363-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004095210</companynumb>
    <primarysource>
      <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>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLTERODINE LA (TOLTERODINE)</medicinalproduct>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>4 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLLAKIURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONEPREZIL (DONEPREZIL)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COGNITIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONEPREZIL (DONEPREZIL)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COGNITIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUXETINE (FLUXETINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519364-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>028-20785-04090595</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD HUMAN CHORIONIC GONADOTROPIN POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugbatchnumb>0173X</drugbatchnumb>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugbatchnumb>0173X</drugbatchnumb>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519365-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004093656</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.318</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL BONES FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>25 MG (25 MG, AS NECESSARY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519366-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004240689US</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HYDROCHLORIDE SOLUTION, STERILE (IRINOTECAN HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>20571</drugauthorizationnumb>
        <drugdosagetext>313.75 MG (CYCLIC), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE (THALIDOMIDE)</medicinalproduct>
        <drugdosagetext>400 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE (ESOMEPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519367-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004095280</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519368-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HD-ADVR-392</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRI-LUMA</medicinalproduct>
        <drugauthorizationnumb>21112</drugauthorizationnumb>
        <drugdosagetext>QD, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>CHLOASMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030806</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519369-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-04807</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANORECTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE STOOLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYTROL</medicinalproduct>
        <drugauthorizationnumb>21351</drugauthorizationnumb>
        <drugdosagetext>1 PATCH, 2/WEEK, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519370-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1000250</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>BACTERIAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CITROBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>21572</drugauthorizationnumb>
        <drugdosagetext>6MG/KG;Q24H;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLYCOPEPTIDE ANTIBIOTIC RESISTANT ENTEROCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINUPRISTIN/DALFOPRISTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM-SULFAMETHOXAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519371-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1000261</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</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 CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>21572</drugauthorizationnumb>
        <drugdosagetext>300 MG; Q24H; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>21572</drugauthorizationnumb>
        <drugdosagetext>300 MG; Q24H; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRASE MT20</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFIVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMICICLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRONABINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRA DS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519372-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MK200411-0203-1</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED ACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE INVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUGULAR VEIN DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>75983</drugauthorizationnumb>
        <drugdosagetext>2000 MG, ONCE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519373-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415426BCC</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102.0593</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>220-440 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>220-440 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519374-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GRP04000228</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NORMAL PRESSURE HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugauthorizationnumb>20835</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519375-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>UKP04000432</companynumb>
    <primarysource>
      <qualification>3</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>THYROTOXIC CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugauthorizationnumb>20835</drugauthorizationnumb>
        <drugdosagetext>35 MG, 1/WEEK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCEOS (CALCIUM CARBONATE, COLECALCIFEROL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519376-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004VX000911</companynumb>
    <primarysource>
      <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>ALVEOLITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>12209</drugauthorizationnumb>
        <drugdosagetext>600 MG; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>100 MG; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519377-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004VX000913</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>12209</drugauthorizationnumb>
        <drugdosagetext>820 MG; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519378-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SGBI-2004-00423</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANAGRELIDE HCL</medicinalproduct>
        <drugauthorizationnumb>20333</drugauthorizationnumb>
        <drugdosagetext>1.5 MG, 3X/DAY:TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL THROMBOCYTHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040806</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519379-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CERZ-10720</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>28.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</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>19980824</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519380-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12187RO</companynumb>
    <primarysource></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>AREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS FLACCID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>1 MG PER EPIDURAL CATHETER  SEE IMAGE</drugdosagetext>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPIVACAINE</medicinalproduct>
        <drugdosagetext>0.2%, 8ML, SEE IAMGE</drugdosagetext>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDOCAINE AND EPINEPHRINE</medicinalproduct>
        <drugdosagetext>2 % WITH 1:200,000 EPI PER EPIDURAL CATHETER SEE IMAGE</drugdosagetext>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>PER EPIDURAL CATHETER SEE IMAGE</drugdosagetext>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519382-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12174RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BOWEL MOVEMENT IRREGULARITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS HELICOBACTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE STOOLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PSEUDOEPHEDRINE (PSEUDOEPHEDRINE)</medicinalproduct>
        <drugdosagetext>240 MG /DAY (30 MG), PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>150 MG, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXTROMETHORPHAN (DEXTROMETHORPHAN)</medicinalproduct>
        <drugdosagetext>80 MG/DAY (10 MG), PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GUAIFENESIN (GUAIFENESIN)</medicinalproduct>
        <drugdosagetext>800 MG/DAY (100 MG), PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>2000 MG/DAY (250 MG), PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519383-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1658</companynumb>
    <primarysource>
      <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 PH INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF MATERNAL EXPOSURE TO THERAPEUTIC DRUGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICARDIPINE INJECTABLE SOLUTION</medicinalproduct>
        <drugauthorizationnumb>74439</drugauthorizationnumb>
        <drugdosagetext>2MG/H INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TOCOLYSIS</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519384-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1651</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTIC ACID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>75972</drugauthorizationnumb>
        <drugdosagetext>1000MG BD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519385-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1657</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICARDIPINE  INJECTABLE SOLUTION</medicinalproduct>
        <drugauthorizationnumb>74439</drugauthorizationnumb>
        <drugdosagetext>3-4MG/H INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TOCOLYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519386-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1656</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICARDIPINE  INJECTABLE SOLUTION</medicinalproduct>
        <drugauthorizationnumb>74439</drugauthorizationnumb>
        <drugdosagetext>3-6MG/H INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TOCOLYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519387-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1655</companynumb>
    <primarysource>
      <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>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICARDIPINE INJECTABLE SOLUTION</medicinalproduct>
        <drugauthorizationnumb>74439</drugauthorizationnumb>
        <drugdosagetext>3-4MG/H INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TOCOLYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519388-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1654</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICARDIPINE  INJECTABLE SOLUTION</medicinalproduct>
        <drugauthorizationnumb>74439</drugauthorizationnumb>
        <drugdosagetext>3-4 MG/H INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TOCOLYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519389-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1653</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICARDIPINE INJECTABLE SOLUTION</medicinalproduct>
        <drugauthorizationnumb>74439</drugauthorizationnumb>
        <drugdosagetext>3-6MG/H INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TOCOLYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519390-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>K200401795</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
        <drugdosagetext>5 MCG/ML</drugdosagetext>
        <drugindication>SURGICAL HAEMOSTASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPIVACAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTATED RINGER'S</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMIFENTANIL (REMIFENTANIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPIVACAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519391-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030908</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2003US03824</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASCRIPTIN BUFFERED MAX STRENGTH CAPLETS (NCH)(ACETYLSALICYLIC ACID) UN</medicinalproduct>
        <drugdosagetext>1000 MG, QPM, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519392-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004089699</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>122.4712</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROLAIDS EXTRA STRENGTH (MAGNESIUM HYDROXIDE, CALCIUM CARBONATE)</medicinalproduct>
        <drugbatchnumb>58164V</drugbatchnumb>
        <drugdosagetext>2 TABLETS 1-2 TIMES QD PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN HUMAN INJECTION, ISOPHANE (INSULIN HUMAN INJECTION, ISOPHANE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519393-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096282</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.3795</patientweight>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMETROL (GLUCOSE, FRUCTOSE, PHOSPHORIC ACID)</medicinalproduct>
        <drugbatchnumb>25JPB</drugbatchnumb>
        <drugdosagetext>TABLESPOON ONCE DAILY PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LETROZOLE (LETROZOLE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519394-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>003630</companynumb>
    <primarysource>
      <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>PREGNANCY OF PARTNER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSMISSION OF DRUG VIA SEMEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugauthorizationnumb>76356</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519395-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-11-1663</companynumb>
    <primarysource>
      <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>COLORECTAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>74949</drugauthorizationnumb>
        <drugdosagetext>50-400MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519396-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1678</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>74949</drugauthorizationnumb>
        <drugdosagetext>500MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519397-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1675</companynumb>
    <primarysource>
      <qualification>3</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>74949</drugauthorizationnumb>
        <drugdosagetext>225-325 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519398-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1674</companynumb>
    <primarysource>
      <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>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>74949</drugauthorizationnumb>
        <drugdosagetext>425-525MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519399-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-11-1662</companynumb>
    <primarysource>
      <qualification>3</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>74949</drugauthorizationnumb>
        <drugdosagetext>300-700MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519400-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097825</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE REDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISINE L.R.</medicinalproduct>
        <drugdosagetext>1 DROP IN EACH EYE</drugdosagetext>
        <drugindication>EYE REDNESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519401-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098633</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE VESICLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DESQUAMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEOSPORIN</medicinalproduct>
        <drugdosagetext>3-4 TIMES</drugdosagetext>
        <drugindication>WOUND</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519402-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098538</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40.8237</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DRAMAMINE</medicinalproduct>
        <drugbatchnumb>95JMW</drugbatchnumb>
        <drugdosagetext>1-2 TABLETS A WEEK, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVOUS SYSTEM DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIMENHYDRINATE (DIMENHYDRINATE)</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NERVOUS SYSTEM DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS (ASCORBIC ACID, ERGOCALCIFEROL, FOLIC ACID, NICOTINAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIHYDROXYALUMINUM SODIUM CARBONATE (DIHYDROXYALUMINUM SODIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519403-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004VX000912</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>12209</drugauthorizationnumb>
        <drugdosagetext>750 MG; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPOPHARYNGEAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>98 MG; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>75 MG; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519404-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-2004-035602</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATION OF PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVONORGESTREL</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519405-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-2004-033601</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACQUIRED PYLORIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFUSE LARGE B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACTOR VII DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE BONE MARROW APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugauthorizationnumb>20038</drugauthorizationnumb>
        <drugdosagetext>25 MG/M2, CYCLES X 3 DAYS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>250 MG/M2, CYCLES X 3 DAYS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILGRASTIM (FILGRASTIM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROPOIETIN (ERYTHROPOIETIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519406-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-2004-035527</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519407-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2004-035671</companynumb>
    <primarysource>
      <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>DISORDER OF ORBIT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugtreatmentduration>1825</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519408-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004069740</companynumb>
    <primarysource>
      <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>EXOPHTHALMOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NODULE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERRAMYCIN HCL</medicinalproduct>
        <drugauthorizationnumb>61014</drugauthorizationnumb>
        <drugdosagetext>MORE THAN 10 YEARS AGO</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519409-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097060</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNACID INJECTION (SULBACTAM, AMPICILLIN)</medicinalproduct>
        <drugauthorizationnumb>50608</drugauthorizationnumb>
        <drugdosagetext>3.222 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519410-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-2004-035692</companynumb>
    <primarysource>
      <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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENOPAUSAL SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVONORGESTREL</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>MENORRHAGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519411-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004091220</companynumb>
    <primarysource>
      <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUFFOCATION FEELING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>5 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM (LOXOPROFEN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSENN (ACHILLEA, RUBIA ROOT TINCTURE, SENNA FRUIT, SENNA LEAF, TARAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEVITOTAL COMP. (ASCORBIC ACID, CALCIUM PANTOTHENATE, NICOTINAMIDE, PY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519412-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004093934</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>5 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519413-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004084534</companynumb>
    <primarysource>
      <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>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>40 MG (40 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519414-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004088700</companynumb>
    <primarysource></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>BLOOD CHOLESTEROL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519415-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097851</companynumb>
    <primarysource>
      <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>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20882</drugauthorizationnumb>
        <drugdosagetext>300 MG (100 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE (PANTOPRAZOLE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519416-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097777</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CALCIFICATION PANCREATIC DUCT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC PSEUDOCYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORTIS (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519417-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413090GDS</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>500 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519418-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413259GDS</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PRERENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTITHROMBIN III DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC DISSECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIA SPUTUM IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugdosagetext>100 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROTROPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519419-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413269GDS</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CUTANEOUS VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASIPRIN CARDIO (ACETYLSALICYLIC ACID)</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugdosagetext>100 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>40 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>15 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENPROCOUMON</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMAN INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519420-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413273GDS</companynumb>
    <primarysource>
      <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>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugdosagetext>80 MG, TOTAL DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIROFIBAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NADROPARIN</medicinalproduct>
        <drugdosagetext>0.6 ML, BID</drugdosagetext>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75 MG, TOTAL DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADROPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519421-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413268GDS</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINCOCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519422-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096163</companynumb>
    <primarysource></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>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519423-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004044152</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040510</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519424-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004091171</companynumb>
    <primarysource>
      <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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>40 MG (40 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugdosagetext>1200 MG (600 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EZETIMIBE (EZETIMIBE)</medicinalproduct>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC (DICLOFENAC)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519425-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004043825</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <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>FACIAL DYSMORPHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROCEPHALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOSE DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE (INSULIN GLARGINE)</medicinalproduct>
        <drugdosagetext>20 TO 30 IU (1 IN 1 D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN LISPRO (INSULIN LISPRO)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519426-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003125476</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEBUTOLOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL (PERINDOPRIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519427-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004092446</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK SECOND DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>1800 MG (300 MG, 6 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYNEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZYLPENICILLIN SODIUM (BENZYLPENICILLIN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC (DICLOFENAC)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519428-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098188</companynumb>
    <primarysource>
      <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>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugauthorizationnumb>87442</drugauthorizationnumb>
        <drugdosagetext>900 MG (1 IN 3 WK), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN HYDROCHLORIDE           (EPIRUBICIN HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>(1 IN 3 WK), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>900 MG (1 IN 4 WK), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGFILGRASTIM (PEGFILGRASTIM)</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FILGRASTIM (FILGRASTIM)</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519429-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097026</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>NEOPLASM PROSTATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDURAN (DOXAZOSIN)</medicinalproduct>
        <drugauthorizationnumb>19668</drugauthorizationnumb>
        <drugdosagetext>4 MG (4 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519430-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097177</companynumb>
    <primarysource>
      <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>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugauthorizationnumb>19949</drugauthorizationnumb>
        <drugdosagetext>(100 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519431-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097617</companynumb>
    <primarysource>
      <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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>(50 MG, 1 IN 1 D),</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519432-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004080722</companynumb>
    <primarysource>
      <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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRIDOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>50784</drugauthorizationnumb>
        <drugdosagetext>500 MG (500 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519433-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097276</companynumb>
    <primarysource>
      <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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>(40 MG)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>MYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519434-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004066756</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519435-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097739</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOR (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519436-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097127</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>50784</drugauthorizationnumb>
        <drugdosagetext>500 MG (500 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519437-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098199</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HYDROCHLORIDE  (IRINOTECAN HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>20571</drugauthorizationnumb>
        <drugdosagetext>160 MG (CYCLE 2), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>4400 MG (CYCLE 2), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>30 MG (CYCLE 2), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519438-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097225</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXEMESTANE           (EXEMESTANE)</medicinalproduct>
        <drugauthorizationnumb>20753</drugauthorizationnumb>
        <drugdosagetext>25 MG (25 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UFT</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519439-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097449</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugauthorizationnumb>12151</drugauthorizationnumb>
        <drugdosagetext>75 MF (75 MG, ONCE DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSIVE CRISIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>25 MCG (ONCE DAILY) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSIVE CRISIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugdosagetext>4 MG (4 MG, ONCE DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSIVE CRISIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugdosagetext>1.5 MG (1.5 MG, ONCE</drugdosagetext>
        <drugindication>HYPERTENSIVE CRISIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>2 DOSE FORMS (ONCE DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOKALAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIPINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519440-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004243961GB</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
        <drugauthorizationnumb>20597</drugauthorizationnumb>
        <drugdosagetext>OPHTHALMIC</drugdosagetext>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519441-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097657</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (400 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZYLPENICILLIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519442-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004236578DE</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKINETIC HEART SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>4 MG (UNKNOWN) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR    (BENSERAZIDE HYDROCHLORIDE, LEVODOPA)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519443-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0281612-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEPROMIZINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUPHENAZINE DECANOATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOFLAZEPATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519444-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004235074FR</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>50 MG/20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DELTASONE</medicinalproduct>
        <drugdosagetext>20 MILLIGRAM (20 MG); ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE (ESOMEPRAZOLE)</medicinalproduct>
        <drugdosagetext>40 MG (40 MG, DAILY); ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIETHYLSTILBESTROL</medicinalproduct>
        <drugdosagetext>1 DF (TID); ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL (CLOPIDOGREL)</medicinalproduct>
        <drugdosagetext>1 DF (DAILY); ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYPROHEPTADINE HCL</medicinalproduct>
        <drugdosagetext>1 DF (BID); ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>......</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.........</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>..........</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.........</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORNITHINE OXOGLURATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>..............</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519445-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004224699JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULOMUCOCUTANEOUS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HYDROCHLORIDE         (IRINOTECAN HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>20571</drugauthorizationnumb>
        <drugdosagetext>60 MG (INTERMITTENT), INTRAVENOUS, (SEE IMAGE)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HYDROCHLORIDE         (IRINOTECAN HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>20571</drugauthorizationnumb>
        <drugdosagetext>60 MG (INTERMITTENT), INTRAVENOUS, (SEE IMAGE)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519446-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097529</companynumb>
    <primarysource>
      <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 CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>63165</drugauthorizationnumb>
        <drugdosagetext>50 MG (CYCLICAL), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>750 MG (CYCLICAL); INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>1.4 MG (CYCLICAL); INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB       (RITUXIMAB)</medicinalproduct>
        <drugdosagetext>375 MG (CYCLICAL); INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519447-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096182</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>100 MG (100 MG, 1 IN 1 D); ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG (75 MG, 1 IN 1 D); ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D); ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEBEVERINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMPLE LINCTUS (AMARANTH, ANISE WATER, CHLOROFORM SPIRIT, CITRIC ACID </medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519448-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004095017</companynumb>
    <primarysource>
      <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>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, ONCE); ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519449-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004093147</companynumb>
    <primarysource>
      <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>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519450-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>090-20785-04110644</companynumb>
    <primarysource>
      <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>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL LOAD INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519451-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-0007532</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugauthorizationnumb>21356</drugauthorizationnumb>
        <drugdosagetext>300 MG, 1 IN 1 D; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISAPRIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519452-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004_000094</companynumb>
    <primarysource>
      <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>BLAST CELLS PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPOCYT</medicinalproduct>
        <drugauthorizationnumb>21041</drugauthorizationnumb>
        <drugdosagetext>50 MG; INTRATHECAL</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC MUPS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMPORTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOZINAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAROTEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAPRED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STESOLID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDOMIGRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEAVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519453-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A044-002-005325</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATATONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SENILE DEMENTIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTORETIC (PRINIZDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INIPOMP (PANTOPRAZOLE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519456-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-SAF-07886-01</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTAN               (BROMAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519458-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-DEN-04699-01</companynumb>
    <primarysource>
      <qualification>3</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>BLOOD ALKALINE PHOSPHATASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD OSMOLARITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AKARIN (CITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTYL MED KALIUMKLORID MITE (BENDROFLUMETHIAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORODIL (ENALAPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURA-ZOK (METOPROLOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOZOP (ZOPICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOCOID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNYL ^SAD^ (ACETYLSALICYLIC AICD)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XATRAL UNO (ALFUZOSIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENEMAL ^ACO^ (PHENOBARBITAL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC (OMEPRAZOLE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519460-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D01200404845</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERFORATED ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>80 MG/M2 CONT - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER EXTENSIVE STAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>120 MGM2 GIVEN ON DAYS 1, 2 AND 3, IN A 30-MINUTE INFUSION - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER EXTENSIVE STAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519462-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-00649</companynumb>
    <primarysource>
      <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>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519463-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-00829</companynumb>
    <primarysource>
      <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>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA EAR</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>4519464-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-00832</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ALVEOLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</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>20040122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL (TRIMETAZIDINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALDINE (LACIDIPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519465-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-00845</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</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>4519467-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02121</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
        <drugdosagetext>1 DF QD O</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VAGOSTABYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519469-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05983</companynumb>
    <primarysource>
      <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>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOCAIN</medicinalproduct>
        <drugauthorizationnumb>89408</drugauthorizationnumb>
        <drugdosagetext>25 ML</drugdosagetext>
        <drugindication>NERVE BLOCK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519471-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004PK01992</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENOSYNOVITIS STENOSANS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGGER FINGER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>20541</drugauthorizationnumb>
        <drugdosagetext>1 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519473-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE05860</companynumb>
    <primarysource>
      <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>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugdosagetext>4-8 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519475-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004PK01771</companynumb>
    <primarysource>
      <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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUTANEOUS LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SICCA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugindication>GASTRIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUENSYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519476-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02344</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugdosagetext>20 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPANTHYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519477-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02340</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW MYELOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugdosagetext>40 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>1 G TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHOPNEUMOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040823</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519478-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>209069</companynumb>
    <primarysource>
      <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>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ALVEOLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB          (RITUXIMAB)</medicinalproduct>
        <drugdosagetext>530 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>700 MG,</drugdosagetext>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRARUBICIN (PIRARUBICIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519480-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210513</companynumb>
    <primarysource>
      <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>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOLIPIN ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B SURFACE ANTIGEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMOOTH MUSCLE ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB OR PLACEBO</medicinalproduct>
        <drugdosagetext>1000 MG, DAYS 1 + 15, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>100 MG, DAYS 1 + 15, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>30 MG, ORAL; 60 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>30 MG, ORAL; 60 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>12.5 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519481-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE06529</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugbatchnumb>EC 1557-07</drugbatchnumb>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugdosagetext>4 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORABET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519483-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP03977</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FUNCTION TEST DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN S</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519484-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02758</companynumb>
    <primarysource>
      <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>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEFITINIB</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-COMADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTATINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULPHATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519486-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004PK02012</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ECZEMA ASTEATOTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEFITINIB</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>500 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATIC SPECIFIC ANTIGEN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEFITINIB</medicinalproduct>
        <drugdosagetext>500 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATIC SPECIFIC ANTIGEN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTO COMP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPIRID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXY-M</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLIBEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519488-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02331</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS ACNEIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEFITINIB</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
        <drugdosagetext>50 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOSERELIN</medicinalproduct>
        <drugdosagetext>3.6 MG Q4WK SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL/ FLUTICASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOW CENTYL K</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519489-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207034</companynumb>
    <primarysource>
      <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>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA       (RITUXIMAB)</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519491-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05937</companynumb>
    <primarysource>
      <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>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AFIPRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORFINSULFAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOCIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMADRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRAMIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519493-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05949</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION MYELOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>150 MG DAILY; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>260 MG WEEK; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG WEEK; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugdosagetext>TOTAL DOSE OF 60 GY GIVEN</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031111</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519494-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05958</companynumb>
    <primarysource>
      <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>ACUTE FEBRILE NEUTROPHILIC DERMATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPNOTICS AND SEDATIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519496-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210586</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL PERICARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519497-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210583</companynumb>
    <primarysource>
      <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugdosagetext>0.75 ML, 1/WEEK; SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEFENAMIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519498-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210822</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>440 MG, Q3W; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMAL (TRAMADOL HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519500-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-087-0279432-00</companynumb>
    <primarysource>
      <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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPARIN-INDUCED THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>5264</drugauthorizationnumb>
        <drugdosagetext>10000 UNIT, NOT REPORTED</drugdosagetext>
        <drugindication>CEREBRAL THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARGATROBAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OZAGREL SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519502-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MK200411-0315-1</companynumb>
    <primarysource>
      <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>TECHNESCAN HDP</medicinalproduct>
        <drugbatchnumb>185038</drugbatchnumb>
        <drugauthorizationnumb>18321</drugauthorizationnumb>
        <drugdosagetext>600 MBQ, SINGLE USE</drugdosagetext>
        <drugindication>SCAN BONE MARROW</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519504-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>20040042USST</companynumb>
    <primarysource>
      <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>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOCARNIL (LEVOCARNITINE)</medicinalproduct>
        <drugauthorizationnumb>19257</drugauthorizationnumb>
        <drugdosagetext>200 MG/ML</drugdosagetext>
        <drugindication>MALNUTRITION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETORNAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAXINOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILLUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOBIAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENERVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519513-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20011122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6011694F</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXANTHEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519515-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003-08-0343</companynumb>
    <primarysource>
      <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>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>10 MU QD INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519516-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1363</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAMETHASONE DIPROPIONATE</medicinalproduct>
        <drugauthorizationnumb>14602</drugauthorizationnumb>
        <drugdosagetext>1 DOSE(S)</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519521-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1458</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519523-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1568</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOLLICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>120-39 MCG</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>120-39 MCG</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>120-39 MCG</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519525-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEU-2004-0001131</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIOPULMONARY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBILEUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALLADONE</medicinalproduct>
        <drugauthorizationnumb>21044</drugauthorizationnumb>
        <drugdosagetext>4 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519526-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>230055M04GBR</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT 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>20030124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519528-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>430001M04IRL</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519530-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>230083K04AUS</companynumb>
    <primarysource>
      <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>HAEMOLYTIC URAEMIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</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>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519532-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05071</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>2.154</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE VIA BREAST MILK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugauthorizationnumb>18240</drugauthorizationnumb>
        <drugdosagetext>0.59 IN BABY'S BLOOD LEVEL</drugdosagetext>
        <drugadministrationroute>063</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519534-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE06199</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>1400 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>600 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOZINAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519535-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CIP04002533</companynumb>
    <primarysource>
      <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>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugauthorizationnumb>20835</drugauthorizationnumb>
        <drugdosagetext>35 MG ONCE WEEKLY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCLIUM CARBONATE (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION (BUPROPION)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519536-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004VX000914</companynumb>
    <primarysource>
      <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>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>12209</drugauthorizationnumb>
        <drugdosagetext>1000 MG; UNKNOWN; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>60 MG; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>100 MG; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519538-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRP04000962</companynumb>
    <primarysource>
      <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>FOREIGN BODY TRAUMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugauthorizationnumb>20835</drugauthorizationnumb>
        <drugdosagetext>35 MG, 1/WEEK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519543-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0411GBR00202</companynumb>
    <primarysource>
      <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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE IIA HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE IIA HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519544-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0411GBR00265</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040427</drugenddate>
        <drugtreatmentduration>569</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040404</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519545-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0407USA00316</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>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>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLETON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519547-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0411FRA00082</companynumb>
    <primarysource>
      <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>CEREBRAL ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALE PATTERN BALDNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519548-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031016</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0310USA01959</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE INVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABYRINTHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PILONIDAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugbatchnumb>L4559</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JOINT DISLOCATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugbatchnumb>L4234</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugbatchnumb>L4559</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JOINT INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugbatchnumb>L4234</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE XR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE AND TRIAMCINOLONE ACETONIDE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020315</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519550-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04121</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>LYME DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519554-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-MERCK-0411SWE00052</companynumb>
    <primarysource>
      <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>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEHEPAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AERIUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519557-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00070</companynumb>
    <primarysource>
      <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>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519558-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00694</companynumb>
    <primarysource>
      <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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519561-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0410CAN00030</companynumb>
    <primarysource>
      <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>GASTRIC OUTLET OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519562-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03481M</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTPARTUM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOULDER DYSTOCIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519563-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03481B1</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTPARTUM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC DELIVERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519564-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-0411ESP00034</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519565-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00375</companynumb>
    <primarysource>
      <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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICOBRACHIAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOANGINA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC PROTRUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519575-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA01003</companynumb>
    <primarysource>
      <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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519576-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04118</companynumb>
    <primarysource>
      <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>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519577-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00471</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANT SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTEBRAL ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040404</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040330</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519578-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00580</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519580-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0412CAN00004</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020701</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519582-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04162</companynumb>
    <primarysource>
      <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>ABASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519583-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0412AUS00016</companynumb>
    <primarysource>
      <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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519584-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04125</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519585-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00006</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CAUDA EQUINA SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CERVICOBRACHIAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519587-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004-1788</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>803</patientonsetageunit>
      <patientweight>3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TALIPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>64076</drugauthorizationnumb>
        <drugdosagetext>TRANS-PLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>TRANS-PLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRUS INFLUENZA (VIRUS INFLUENZA)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRON (IRON)</medicinalproduct>
        <drugdosagetext>TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERMETHRIN (PERMETHRIN)</medicinalproduct>
        <drugdosagetext>TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE (BECLOMETHASONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519588-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004-1800</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED CELL DISTRIBUTION WIDTH INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugauthorizationnumb>74052</drugauthorizationnumb>
        <drugdosagetext>25MG ONCE A DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10MG DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE  (BENDROFLUAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICAZIDE (GLICAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519590-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040913</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004-1803</companynumb>
    <primarysource>
      <qualification>3</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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARIDOPA/LEVODOPA</medicinalproduct>
        <drugauthorizationnumb>73586</drugauthorizationnumb>
        <drugindication>PARKINSONIAN GAIT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOVICOL (POTASSIUM CHLORIDE/MACROGOL/SODIUM BICARBONATE/SODIUM CHLORID</medicinalproduct>
        <drugdosagetext>2 SACHETS</drugdosagetext>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPICLONE (ZOPICLONE)</medicinalproduct>
        <drugdosagetext>3.75 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519592-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004-1801</companynumb>
    <primarysource>
      <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>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC UNK UNKNOWN MANUFACTURER</medicinalproduct>
        <drugauthorizationnumb>74376</drugauthorizationnumb>
        <drugdosagetext>50MG TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>10 MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CO-CODAMOL (CODEINE/PARACETAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOTHIEPIN (DOTHIEPIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519593-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004-1802</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGLE CLOSURE GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE</medicinalproduct>
        <drugauthorizationnumb>75887</drugauthorizationnumb>
        <drugdosagetext>50MG DAILY</drugdosagetext>
        <drugindication>TENSION HEADACHE</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLAUCOMA TREATMENT WITH TIMOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519594-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00021</companynumb>
    <primarysource>
      <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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010601</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010601</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519595-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00052</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519596-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00016</companynumb>
    <primarysource>
      <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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519597-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00023</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519599-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004-1804</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE</medicinalproduct>
        <drugauthorizationnumb>75887</drugauthorizationnumb>
        <drugdosagetext>100 MG DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519600-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00168</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519601-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0302USA00107</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRUNNER'S GLAND HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK LEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS NEUROSENSORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF BLOCK IN EAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010412</drugenddate>
        <drugtreatmentduration>478</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010412</drugenddate>
        <drugtreatmentduration>478</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIOMEGALY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIOMEGALY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519602-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004-1798</companynumb>
    <primarysource>
      <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>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugauthorizationnumb>70663</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRALYSAL</medicinalproduct>
        <drugdosagetext>1 OD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ROSACEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519603-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00035</companynumb>
    <primarysource>
      <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>BRADYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519604-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00043</companynumb>
    <primarysource>
      <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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519606-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00079</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519607-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098429</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINUTAB II (PARACETAMOL, PSEUDOEPHEDRINE)</medicinalproduct>
        <drugdosagetext>500 MG/30 MG, 3 TABLETS TOTAL, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMHEXINE HYDROCHLORIDE (BROMHEXINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANE (CYPROTERONE ACETATE, ETHINYLESTRADIOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519608-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04266</companynumb>
    <primarysource>
      <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>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519609-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04244</companynumb>
    <primarysource>
      <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519610-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04265</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519611-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00046</companynumb>
    <primarysource>
      <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>AORTIC DISSECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519613-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0302USA00123</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIASTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLIC CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIANOPIA HOMONYMOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTROPHIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTOSE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARROW HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE ON EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITTING OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY GLAND DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010701</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010701</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519614-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-AP-00237AP</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugdosagetext>1 ANZ (80 MG), PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN (BLIDN) (VALSARTAN)</medicinalproduct>
        <drugdosagetext>1 ANZ (160 MG), PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO (BLIND) (PLACEBO)</medicinalproduct>
        <drugdosagetext>1 ANZ (NR), PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EGILAK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519619-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA02080</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>27</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DESQUAMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRODIF</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519620-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-MERCK-0411TWN00017</companynumb>
    <primarysource>
      <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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519635-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1002316</companynumb>
    <primarysource></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>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>100MG BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEMANTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE WITH VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA/DUCUSATE</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>BISACODYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENEFIBER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOTAXIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROSE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519636-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1003441</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>100MG TID, 300MG HS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519637-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>003596</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugbatchnumb>409254006</drugbatchnumb>
        <drugauthorizationnumb>40145</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugbatchnumb>408323041</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugbatchnumb>208314016</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519638-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-11-1632</companynumb>
    <primarysource>
      <qualification>3</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>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>74949</drugauthorizationnumb>
        <drugdosagetext>100MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519639-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0411GBR00261</companynumb>
    <primarysource>
      <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>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519640-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00492</companynumb>
    <primarysource>
      <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>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MESENTERIC VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001013</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519641-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1003463</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>100MG QAM AND 200MG HS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519642-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1003452</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.7913</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugbatchnumb>1M0947</drugbatchnumb>
        <drugauthorizationnumb>74215</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugbatchnumb>1M0947</drugbatchnumb>
        <drugauthorizationnumb>74215</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugbatchnumb>1M0947</drugbatchnumb>
        <drugauthorizationnumb>74215</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519643-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1003155</companynumb>
    <primarysource></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>DEMENTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>25MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IV HYDRATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519644-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1003451</companynumb>
    <primarysource></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>APPENDICECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>50MG BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>500MG HS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALPHA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519645-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1003023</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.246</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>75MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>100MG, BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519646-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0411AUS00228</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519647-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA04399</companynumb>
    <primarysource>
      <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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGRAPHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519648-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041106067</companynumb>
    <primarysource>
      <qualification>1</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>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519649-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041106071</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <reaction>
        <reactionmeddrapt>LUNG ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>300 - 400MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALIMUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519650-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041106109</companynumb>
    <primarysource>
      <qualification>5</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519651-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041106117</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO OVARY</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>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519652-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-JNJFOC-20041106153</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <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>4519653-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-JNJFOC-20041106156</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <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>4519654-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20041106720</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</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>CELEBREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>0.8ML</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519655-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041002958</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NECROTISING FASCIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOTHERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519657-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20041004741</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOPULMONARY ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RELAPSING POLYCHONDRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519658-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105907</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SJOGREN'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519659-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12252</companynumb>
    <primarysource>
      <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>RETINAL ARTERY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VASCULAR THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TINEA CAPITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040627</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519660-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04326</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugdosagetext>75 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>350MG NOCTE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugdosagetext>50 MG, TID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>15ML NOCTE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>1-2 BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>300 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEFOPAM</medicinalproduct>
        <drugdosagetext>600 MG, TID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL STIFFNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519661-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2003FR07999</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CGS 20267 VS TAMOXIFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519662-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP14251</companynumb>
    <primarysource>
      <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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUVOX</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519663-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB03700</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECOTIDE</medicinalproduct>
        <drugdosagetext>2 PUFFS, QID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugdosagetext>2 SACHETS 250 ML/QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>20 ML, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM AMYTAL</medicinalproduct>
        <drugdosagetext>120 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>2 PUFFS/QID</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>200MG BD + 400MG BD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>20MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519664-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CA15740</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFLUENZA VACCINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOSERELIN ACETATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS,OTHER</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519665-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004IT15612</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMESIN</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519666-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004RO15892</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POLYSEROSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519667-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040910</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2004AU01418</companynumb>
    <primarysource>
      <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>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN LA</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519668-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004NO16812</companynumb>
    <primarysource>
      <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>CHOLECYSTITIS INFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLECTOMY PARTIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DRAINAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>75 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAD</medicinalproduct>
        <drugdosagetext>0.75 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040908</drugenddate>
        <drugtreatmentduration>104</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519669-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BR16048</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITRIDERM TTS</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519670-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BR16029</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>0.25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELOKEN</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARGININE</medicinalproduct>
        <drugdosagetext>MANIPULATED PRODUCT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARNITINE</medicinalproduct>
        <drugdosagetext>MANIPULATED PRODUCT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugdosagetext>MANIPULATED PRODUCT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISKEMIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519671-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12693</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>UNK,UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519672-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004NL16670</companynumb>
    <primarysource>
      <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>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CO-DIOVAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519673-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004AR15965</companynumb>
    <primarysource>
      <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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENURESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugdosagetext>1.5 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519674-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004ZA16754</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGASEROD</medicinalproduct>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519675-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US10482</companynumb>
    <primarysource>
      <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>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519676-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04121</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519677-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP12940</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>30</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BETA 2 MICROGLOBULIN URINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BETA-N-ACETYL-D-GLUCOSAMINIDASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY KIDNEY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALDOSTERONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALDOSTERONISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHALAMO-PITUITARY DISORDERS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ALKALOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDO-BARTTER SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ELECTROPHORESIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>25 MG/DAY</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020810</drugenddate>
        <drugtreatmentduration>40320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030227</drugenddate>
        <drugtreatmentduration>2627</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAXATIVES</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYCYRRHIZINATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19941001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>25 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020607</drugenddate>
        <drugtreatmentduration>1753</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519678-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004DE17015</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIGANTOLETTEN ^BAYER^</medicinalproduct>
        <drugdosagetext>500 IU, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE</medicinalproduct>
        <drugdosagetext>4 MG QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040315</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519679-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12349</companynumb>
    <primarysource>
      <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 PRESSURE SYSTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL TENESMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>2 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519680-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CA15882</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>12 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519681-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004CA16748</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040614</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519682-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CA15688</companynumb>
    <primarysource>
      <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>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APO-FLURAZEPAM</medicinalproduct>
        <drugdosagetext>300 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UREMOL</medicinalproduct>
        <drugdosagetext>2 OR 3 TIMES PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>29 VITAMINS+MINERALS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELESTODERM</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>2 MG EVERY 4 - 6 HOURS</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>200 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEDICATION ERROR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>27.5 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOLITH</medicinalproduct>
        <drugdosagetext>900 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HISTANTIL</medicinalproduct>
        <drugdosagetext>50 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>30 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>5 MG IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugdosagetext>3 TABLETS/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPIDIL</medicinalproduct>
        <drugdosagetext>160 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519683-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP13987</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</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 LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMOX</medicinalproduct>
        <drugdosagetext>100 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATHEROSCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>25 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POSTOPERATIVE ANALGESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519684-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04104</companynumb>
    <primarysource>
      <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>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>300MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>20MG/DAY</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
        <drugtreatmentduration>251</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519685-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP14747</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARCINOEMBRYONIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>45 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>90 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>90 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
        <drugtreatmentduration>95040</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519686-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CA15856</companynumb>
    <primarysource>
      <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>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICAL MASTECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>200 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519687-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04348</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>80 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>21 MG/ML, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE</medicinalproduct>
        <drugdosagetext>4 MG, QW</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519688-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE03876</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMMUNICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRA-SAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAROTEN ^BAYER VITAL^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugdosagetext>10MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519689-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004IE15846</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CO-DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519690-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15939</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>25920</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519691-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE03990</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCOL</medicinalproduct>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519692-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12642</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugdosagetext>1 SPRAY, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519693-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP14301</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN G INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCHOL</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040506</drugenddate>
        <drugtreatmentduration>61920</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCHOL</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
        <drugtreatmentduration>95040</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519694-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040519</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE01917</companynumb>
    <primarysource>
      <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 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK LEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRENANTONE</medicinalproduct>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYTIDE H</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>250 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040518</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519695-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03454</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519696-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP14854</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>125 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519697-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP13804</companynumb>
    <primarysource>
      <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>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIZE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOUTOUSAN</medicinalproduct>
        <drugdosagetext>2.5 G, BID</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519698-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004CA16639</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>1503</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519699-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE02253</companynumb>
    <primarysource>
      <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>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519700-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04389</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGUS CSF TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS,OTHER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519701-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15899</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STARSIS</medicinalproduct>
        <drugdosagetext>270 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUITRAN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOZYM</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519702-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040824</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US09162</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugdosagetext>180 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugdosagetext>0.15 MG, QD</drugdosagetext>
        <drugindication>THYROID GLAND CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
        <drugdosagetext>1, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX /USA/</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519703-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004FI15845</companynumb>
    <primarysource>
      <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>GRANULOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>250 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519704-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12025</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA GENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>15840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLENDIL</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519705-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12658</companynumb>
    <primarysource></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>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>80/12.5 MG DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519706-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP14028</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041010</drugenddate>
        <drugtreatmentduration>143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519707-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12858</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>197</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041127</drugenddate>
        <drugtreatmentduration>43200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugdosagetext>800 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>Q-VEL MUSCLE RELAXANT PAIN RELIEVERS (NCH)</medicinalproduct>
        <drugdosagetext>260 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519708-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12748</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>150</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MONOCYTE PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
        <drugtreatmentduration>51840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519709-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004RU16030</companynumb>
    <primarysource>
      <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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYVITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>250 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519710-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP14751</companynumb>
    <primarysource>
      <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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUP-4</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519711-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BR15858</companynumb>
    <primarysource>
      <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>OPTIC ISCHAEMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADELFAN-ESIDREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519712-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004AT15968</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519713-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004JP13979</companynumb>
    <primarysource>
      <qualification>1</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030804</drugenddate>
        <drugtreatmentduration>40320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030810</drugenddate>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030816</drugenddate>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040730</drugenddate>
        <drugtreatmentduration>349</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>44640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519714-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2003FR00706</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VEIN OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE ^LIPHA^</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCIDORAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519715-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004TR16000</companynumb>
    <primarysource>
      <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 THYROID STIMULATING HORMONE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IODINE UPTAKE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>600 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519716-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03143</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONIC CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>1 DF, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040824</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519717-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03459</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD FIBRINOGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugindication>ADRENOCORTICAL INSUFFICIENCY CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDROCORTISONE ACETATE TAB</medicinalproduct>
        <drugindication>ADRENOCORTICAL INSUFFICIENCY CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JOINT INJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040919</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519718-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CR15756</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519719-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15489</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE STOOL POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN D DIMER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN DEGRADATION PRODUCTS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SHOCK SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIVELESTAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN SODIUM</medicinalproduct>
        <drugdosagetext>2 G/DAY</drugdosagetext>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031227</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>50 MG/DAY</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031228</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519720-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP14254</companynumb>
    <primarysource>
      <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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519721-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041106081</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519722-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041106197</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA CYTOMEGALOVIRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>THIRD DOSE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <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</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519723-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041106499</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</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>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519724-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>APCDSS2003000706</companynumb>
    <primarysource>
      <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>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 POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE IV HYPERSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>5MG/KG</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALAZOPYRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030223</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAIKENCHUYA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OZEX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POSTERISAN FORTE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POSTERISAN FORTE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POSTERISAN FORTE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POSTERISAN FORTE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POSTERISAN FORTE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTERAL NUTRITION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519725-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>APCDSS2003000337</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OZEX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OZEX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALAZOPYRIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELENTAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELENTAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519726-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041200454</companynumb>
    <primarysource>
      <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>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519727-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041106060</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</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>
        <drugdosagetext>DOSE= 6 TABLETS A WEEK</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRENOCORTICAL HORMONE</medicinalproduct>
        <drugdosagetext>HAS BEEN OB FOR 13 YEARS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENET</medicinalproduct>
        <drugdosagetext>1 DOSE= 1 TABLET</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>1 DOSE= 1 TABLET</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTELUC</medicinalproduct>
        <drugdosagetext>1 DOSE= 1 TABLET</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSSEN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVER</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519728-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20040403229</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>42.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INH</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TUBERCULOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>HALF A 5MG TABLET A DAY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINORIL</medicinalproduct>
        <drugdosagetext>2 100MG TABLETS A DAY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugdosagetext>ONE TABLET A DAY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040415</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519729-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>10 MG   EVERY 12 HOUR  INTRAVENOU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519730-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.369</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>M32431</drugbatchnumb>
        <drugdosagetext>750MG  QWK   INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugbatchnumb>M26810</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519731-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519732-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004TW12886</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519733-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15630</companynumb>
    <primarysource>
      <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>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519734-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12848</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMADESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DESQUAMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519735-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.9259</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELLS SEMEN POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERLEUKIN-2 (IL-2)</medicinalproduct>
        <drugdosagetext>720,000 IU/KG  IV BOLUS  Q. 8 HRS/13 DOSES CYCLE</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519736-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>91MG   24HR X 3 D   INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>1190   30MIN X 3   INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519737-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF PRESSURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZICAM</medicinalproduct>
        <drugdosagetext>1 SPRAY  ONCE  NASAL</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519738-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZICAM COLD REMEDY</medicinalproduct>
        <drugbatchnumb>O13M1</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010320</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519739-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12769253</companynumb>
    <primarysource>
      <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>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHAEOCHROMOCYTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOZITEC</medicinalproduct>
        <drugdosagetext>DISCONTINUED BETW 29-SEP-2004 AND 02-OCT-2004, REPLACED BY TRIATEC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLCHIMAX</medicinalproduct>
        <drugdosagetext>1 DOSEAGE FORM 1 IN 1 D WAS DOUBLED ON 24-SEP-2004</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugdosagetext>DISCONTINUED BETW 29-SEP-2004 AND 02-OCT-2004</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugdosagetext>DISCONTINUED BETW 29-SEP-2004 AND 02-OCT-2004, REPLACED BY VASTEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugdosagetext>DISCONTINUED BETW 29-SEP-2004 AND 02-OCT-2004</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KREDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519740-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12775979</companynumb>
    <primarysource>
      <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>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT RELATED SECONDARY MALIGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOMYCIN-C</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519741-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-12783411</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FARMORUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519742-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519743-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106.1417</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>110 MG IV Q D1,D8</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>110 MG IV Q D1,D8</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>110 MG IV Q D1,D8</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>786 MG IV 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>786 MG IV 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRUBOPRIM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519744-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>3 MG</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519745-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43.3185</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN-SR</medicinalproduct>
        <drugdosagetext>20 MG 2 TAB PO Q AM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADJUSTMENT DISORDER WITH DEPRESSED MOOD</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519746-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.0396</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugdosagetext>2-3 G 2-3 HR # 300</drugdosagetext>
        <drugindication>SICKLE CELL ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugdosagetext>Q 8 HRS # 90</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519747-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>300 MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519748-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.1637</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>1 TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519749-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ABBOTT-04P-150-0281644-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRE-ECLAMPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040911</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519750-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-04P-013-0281733-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKINE SYRUP</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>3 INTAKES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKINE SYRUP</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519751-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ABBOTT-04P-150-0281642-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040911</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519752-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXEDRINE</medicinalproduct>
        <drugdosagetext>15 MG TID</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519753-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0281534-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43.13</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PORPHYRIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTHROID 25 MCG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROGOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519754-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.4827</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519755-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CN15900</companynumb>
    <primarysource>
      <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>HEPATOSPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD TRANSFUSION, AUXILIARY PRODUCTS</medicinalproduct>
        <drugdosagetext>EVERY 15 DAYS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESFERAL</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BLOOD IRON INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519756-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BR15980</companynumb>
    <primarysource>
      <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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>600 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519757-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12119</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519758-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12755</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROXINE FREE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>100 MG, QHS</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABITRIL</medicinalproduct>
        <drugdosagetext>8 MG, BID</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugdosagetext>100 MG, QHS</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519759-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.7507</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519760-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODAL RHYTHM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519761-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.6068</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200MG  QD  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519762-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>25MG  PRN  INTRAVENOU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIZZINESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>12.5     PRN    INTRAVENOU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519763-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.2554</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE   150 MCG   MYLAN</medicinalproduct>
        <drugdosagetext>150 MCG  ONCE DAILY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519764-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugbatchnumb>NDC 0149-0472-01</drugbatchnumb>
        <drugdosagetext>ONE  WEEKLY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugbatchnumb>NDC 0149-0472-01</drugbatchnumb>
        <drugdosagetext>ONE  WEEKLY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519765-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041231</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE/HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041231</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519766-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03469</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO POSITIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>1 G, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>600 MG MORNING AND EVENING, 300 MG NOON</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519767-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03234</companynumb>
    <primarysource>
      <qualification>1</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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIPSYCHOTIC DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DIET</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEPRONIZINE</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERESTA</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERALITHE</medicinalproduct>
        <drugdosagetext>600 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519768-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>1 TABLET DAILY BY MOUTH</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519769-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.1637</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>1 TAB PER DAY ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN INJECTIONS REGULAR NPH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519770-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117.9352</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FUNCTION TEST DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIMMUNE</medicinalproduct>
        <drugdosagetext>200MCG  3X PER WEEK  SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PULMONARY FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040304</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519771-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF WHITE BLOOD CELL COUNT POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DESTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE REMOVAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALMONELLA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALMONELLOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>40MG   EVERY2WEEKS  SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519772-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040804</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP10396</companynumb>
    <primarysource>
      <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARLODEL</medicinalproduct>
        <drugdosagetext>7.5 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENESIT</medicinalproduct>
        <drugdosagetext>3 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIBASIC CALCIUM PHOSPHATE</medicinalproduct>
        <drugdosagetext>2 G/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROTROPIN</medicinalproduct>
        <drugdosagetext>12 IU/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRORENAL</medicinalproduct>
        <drugdosagetext>10 UG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519773-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03469</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTIBODY TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO POSITIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>1 G, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>600 MG MORNING AND EVENING, 300 MG NOON</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519774-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAVENTRICULAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN  5 MG AND 7.5 MG</medicinalproduct>
        <drugdosagetext>5/7.5 MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE CHONDROITIN</medicinalproduct>
        <drugdosagetext>6 TABLETS DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519775-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>ONCE DAILY  BY MOUTH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519776-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>110</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUADRIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25 MG   PRN-Q-DAY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519777-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPECTRACEF</medicinalproduct>
        <drugdosagetext>400 MG  TWICE DAILY BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPECTRACEF</medicinalproduct>
        <drugdosagetext>400 MG  TWICE DAILY BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYROCODONE/HOMATROPINE SYRUP  NOT ON THE LABEL MORTON GROVE</medicinalproduct>
        <drugdosagetext>1TSP  EVERY 6 HRS BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYROCODONE/HOMATROPINE SYRUP  NOT ON THE LABEL MORTON GROVE</medicinalproduct>
        <drugdosagetext>1TSP  EVERY 6 HRS BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519778-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.6788</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1500 MG/M2 IV 150 M [Q 3 WEEKS]</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1500 MG/M2 IV 150 M [Q 3 WEEKS]</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1500 MG/M2 IV 150 M [Q 3 WEEKS]</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYLANTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519779-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugdosagetext>100 MGM 2-2, 2-2 1-2 ALT Q 3 DAYS/LIFETIME</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519780-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENERIC MICRONOR</medicinalproduct>
        <drugdosagetext>1 PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOMETRORRHAGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519781-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103.4201</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUSPICIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMIPRAMINE HCL 50 MG SANDOZ</medicinalproduct>
        <drugbatchnumb>726567</drugbatchnumb>
        <drugdosagetext>50 MG X 1 TAB</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMIPRAMINE HCL 50 MG SANDOZ</medicinalproduct>
        <drugbatchnumb>726567</drugbatchnumb>
        <drugdosagetext>50 MG X 1 TAB</drugdosagetext>
        <drugindication>URINARY INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519782-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>1 Q HS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519783-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>326 MG IV X 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010606</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL INHALER VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIMENHYDRINATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519784-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR 400 MG PO DAILY</medicinalproduct>
        <drugdosagetext>400 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519785-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>1 AM + 2 PM (PO)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519786-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>1 PO Q 4-6 PRN [LONGTERM]</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>1 PO Q 4-6 PRN [LONGTERM]</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>1 PO Q 4-6 PRN [LONGTERM]</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519787-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.977</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG-PO I TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519788-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER SITE CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERRATIA SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARA C</medicinalproduct>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VCR IV</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VCR IV</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VCR IV</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VCR IV</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE PO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN IV</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN IV</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN IV</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN IV</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-ASPARAGINASE IM</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRENALIN IN OIL INJ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519789-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>CATHETER SITE DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>2380 MGS 1 WEEKLY X3 WEEKS</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519790-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041105801</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519791-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041002052</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519792-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040901331</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040528</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519793-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040501797</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAT STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROCKY MOUNTAIN SPOTTED FEVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LODINE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMIG</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIVORA-21</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIVORA-21</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugdosagetext>17 G, ONCE TO TWICE DAILY, AS NECESSARY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>LAXATIVE SUPPORTIVE CARE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519794-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>175 MG/M2, 3/52 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PERITONEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>AUC 5, 3/52 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PERITONEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519795-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.3586</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRAMUSTINE 140 MG PO BID</medicinalproduct>
        <drugdosagetext>140 MG PO BID D 1-5 (SEE NOTES)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRAMUSTINE 140 MG PO BID</medicinalproduct>
        <drugdosagetext>140 MG PO BID D 1-5 (SEE NOTES)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRAMUSTINE 140 MG PO BID</medicinalproduct>
        <drugdosagetext>140 MG PO BID D 1-5 (SEE NOTES)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRAMUSTINE 140 MG PO BID</medicinalproduct>
        <drugdosagetext>140 MG PO BID D 1-5 (SEE NOTES)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRAMUSTINE 140 MG PO BID</medicinalproduct>
        <drugdosagetext>140 MG PO BID D 1-5 (SEE NOTES)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRAMUSTINE 140 MG PO BID</medicinalproduct>
        <drugdosagetext>140 MG PO BID D 1-5 (SEE NOTES)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRAMUSTINE 140 MG PO BID</medicinalproduct>
        <drugdosagetext>140 MG PO BID D 1-5 (SEE NOTES)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRAMUSTINE 140 MG PO BID</medicinalproduct>
        <drugdosagetext>140 MG PO BID D 1-5 (SEE NOTES)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRAMUSTINE 140 MG PO BID</medicinalproduct>
        <drugdosagetext>140 MG PO BID D 1-5 (SEE NOTES)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRAMUSTINE 140 MG PO BID</medicinalproduct>
        <drugdosagetext>140 MG PO BID D 1-5 (SEE NOTES)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRAMUSTINE 140 MG PO BID</medicinalproduct>
        <drugdosagetext>140 MG PO BID D 1-5 (SEE NOTES)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>TAXOTERE 40MG/M2</drugdosagetext>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>TAXOTERE 40MG/M2</drugdosagetext>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>TAXOTERE 40MG/M2</drugdosagetext>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>TAXOTERE 40MG/M2</drugdosagetext>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>TAXOTERE 40MG/M2</drugdosagetext>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>TAXOTERE 40MG/M2</drugdosagetext>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>TAXOTERE 40MG/M2</drugdosagetext>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>TAXOTERE 40MG/M2</drugdosagetext>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040712</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519796-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.0906</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANCER PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRASMUSTINE 140 MG</medicinalproduct>
        <drugdosagetext>140 MG BID (2X DAILY DAYS 1-5 WEEKS 1-3)</drugdosagetext>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRASMUSTINE 140 MG</medicinalproduct>
        <drugdosagetext>140 MG BID (2X DAILY DAYS 1-5 WEEKS 1-3)</drugdosagetext>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRASMUSTINE 140 MG</medicinalproduct>
        <drugdosagetext>140 MG BID (2X DAILY DAYS 1-5 WEEKS 1-3)</drugdosagetext>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>DOCETAXEL 85MG IV WEEK 1-3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>DOCETAXEL 85MG IV WEEK 1-3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>DOCETAXEL 85MG IV WEEK 1-3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519797-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041104143</companynumb>
    <primarysource>
      <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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugdosagetext>ONE 100 UG/HR PATCH PLUS ONE 50 UG/HR PATCH</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>MEDICATION ERROR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519798-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040906254</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>PROSTATITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>5 MG, ORALLY, EVERY 4-6 HOURS AS NEEDED</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519799-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041004401</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0410560;0307386</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519800-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACITAXEL</medicinalproduct>
        <drugdosagetext>175MG/M2/IV/3/52</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PERITONEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>AUC 6/ IV / 3 / 52</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PERITONEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519801-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB MESYLATE 100MG CAPSULES, NOVARTIS</medicinalproduct>
        <drugdosagetext>600MG, PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE, SCHERING-PLOUGH</medicinalproduct>
        <drugdosagetext>450MG, PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519802-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATIONS, MIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPRISONMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL ASSAULT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE TABLETS 25 MG</medicinalproduct>
        <drugdosagetext>1 TABLET AT NIGHT DAILY</drugdosagetext>
        <drugindication>BLADDER DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021004</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE TABLETS 25 MG</medicinalproduct>
        <drugdosagetext>1 TABLET AT NIGHT DAILY</drugdosagetext>
        <drugindication>OFF LABEL USE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021004</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE TABLETS 25 MG</medicinalproduct>
        <drugdosagetext>1 TABLET AT NIGHT DAILY</drugdosagetext>
        <drugindication>PROSTATIC DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021004</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE TABLETS 25 MG</medicinalproduct>
        <drugdosagetext>1 TABLET AT NIGHT DAILY</drugdosagetext>
        <drugindication>URINARY TRACT DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021004</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519803-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN-XR</medicinalproduct>
        <drugdosagetext>100  MG DAILY</drugdosagetext>
        <drugindication>HIP ARTHROPLASTY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN-XR</medicinalproduct>
        <drugdosagetext>100  MG DAILY</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>75 MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519804-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519805-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE STOOLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>100 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugdosagetext>25 MCG Q3DAYS DERM</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>850 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUCOSAL INFLAMMATION</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519806-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>250  MG/DAY</drugdosagetext>
        <drugindication>COLON CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>CPT-11 WEEKS 1,2,4, + 5</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXACILLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519807-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEMICAL BURN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DESQUAMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>1  A DAY</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519808-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004FR15114</companynumb>
    <primarysource>
      <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>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMYOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERGOT POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTENSOR PLANTAR RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERMITTENT CLAUDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE CONDUCTION STUDIES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEDAL PULSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POPLITEAL PULSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS CONJUGATED W/PROGESTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>40 MG, QID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>122</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYSERGIDE MALEATE</medicinalproduct>
        <drugdosagetext>1.65 MG, TID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIHYDROERGOTAMINE MESYLATE</medicinalproduct>
        <drugdosagetext>10 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>87840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519809-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20041106135</companynumb>
    <primarysource>
      <qualification>1</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>TRIASPORIN</medicinalproduct>
        <drugdosagetext>100MG/DIE</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>GLOSSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXYCILLIN CLAVULANIC ACID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXYCILLIN CLAVULANIC ACID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>GLOSSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519810-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-JNJFOC-20041106210</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAKTACORT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519811-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041004277</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519812-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041105803</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOCET</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugindication>UNEVALUABLE EVENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIENAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIENAM</medicinalproduct>
        <drugindication>UNEVALUABLE EVENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TADENAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIHYDROERGOTAMINE MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPT-A-MYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DANATROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519813-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-JNJFOC-20041106169</companynumb>
    <primarysource>
      <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 CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARIVID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRAX</medicinalproduct>
        <drugdosagetext>1 TAB/DAY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENATEC</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEMAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEMAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519814-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.7507</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>250MG ONCE/DAY ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>75 MG/M2</drugdosagetext>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>1000 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OS-CAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519815-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>60 MG/M2  WEEK + 3</drugdosagetext>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519816-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041106537</companynumb>
    <primarysource>
      <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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPALGIC</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DI-ANTALVIC</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DI-ANTALVIC</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUBAIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FLUDEX</medicinalproduct>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>BI-PROFENID</medicinalproduct>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELISOR</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519817-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041106608</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASPHYXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPALGIC</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>SCIATICA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTON PUMP INHIBITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKENAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORLAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519818-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-JNJFOC-20041106620</companynumb>
    <primarysource>
      <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>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519819-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84.369</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN   40 MG VIAL  PHARMACIA + UPJOHN</medicinalproduct>
        <drugdosagetext>60 MG/M2  DAYS 1,     INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>60 MG/M2   DAY 1 Q  INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON IV</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519820-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20041101705</companynumb>
    <primarysource>
      <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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLEX</medicinalproduct>
        <drugbatchnumb>GKL158</drugbatchnumb>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>POST PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519821-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>VARIOUS, VARIOUS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MITRAL VALVE REPLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERBINAFINE HYDROCHLORIDE CREAM 1%</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519822-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>VARIOUS, VARIOUS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERIPHERAL VASCULAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519823-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041106356</companynumb>
    <primarysource>
      <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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMENSTRUAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519824-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040604600</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115.21</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519825-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>127.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>VARIOUS, VARIOUS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX/VITAMIN C</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519826-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>VARIOUS, VARIOUS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SO4</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SO4 IR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILGRASTIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCTREOTIDE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519827-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>125.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>VARIOUS, VARIOUS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN 70/30 NOVOLIN HUMAN INJ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE SOLN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN NPH NOVOLIN HUMAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SOD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN 70/30 NOVOLIN HUMAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE (IMMEDIATE RELEASE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIFICIAL TEARS POLYVINYL ALCOHOL SOLN, OPH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM CAP, ORAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMETHICONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519828-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040909</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12701694</companynumb>
    <primarysource>
      <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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>START DATE:  19-JUN-2003</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugdosagetext>START DATE:  19-JUN-2003</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>START DATE:  19-JUN-2003</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030731</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519829-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004FI16171</companynumb>
    <primarysource>
      <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>BONE MARROW TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUSARIUM INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRRADIATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTILYMPHOCYTE GLOBULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE MARROW TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519830-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-240800</companynumb>
    <primarysource>
      <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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FACTOR VII DEFICIENCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519831-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>VARIE, VARIOUS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCU-CHEK COMFORT CV (GLUCOSE) TEST STRIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIFICIAL TEARS POLYVINYL ALCOHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANCET, SOFT TOUCH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOISTURIZING LOTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRETINOIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519832-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-NOVOPROD-239759</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN DETEMIR</medicinalproduct>
        <drugdosagetext>6 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>42 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NARDIL</medicinalproduct>
        <drugdosagetext>105 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
        <drugtreatmentduration>28800</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519833-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004GR16194</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOVENOUS GRAFT SITE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA OF SITES OTHER THAN SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION EXCISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NODULE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519834-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16071</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRENOCORTICOTROPHIC HORMONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN</medicinalproduct>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519835-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CH15959</companynumb>
    <primarysource>
      <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>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugdosagetext>750 MG/D</drugdosagetext>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519836-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004IT15935</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519837-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE03411</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugdosagetext>UNK MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519838-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004DK15844</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
        <drugtreatmentduration>23040</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519839-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15852</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPONDYLITIC MYELOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519840-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2004AU01642</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER CATHETER MANAGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISKEN</medicinalproduct>
        <drugdosagetext>30 MG DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519841-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040824</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US09185</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LITHOTRIPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL COLIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519842-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20040401176</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRE-ECLAMPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPITOMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519843-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041106083</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>1.68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPITOMAX</medicinalproduct>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040302</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519844-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040701869</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOMALACIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAT STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOARSENESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE STOOLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEXPECTED THERAPEUTIC DRUG EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>(2) 25 MG TABS/DAY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>(3) 25 MG TABS/DAY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>25 MG TABS (4) AT NIGHT.</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONIPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugdosagetext>(2) AT NIGHT AND (1) IN THE MORNING.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>(2) AT NIGHT AND (1) IN THE MORNING.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL ULTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugdosagetext>2 PUFFS/3 TIMES A DAY.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519845-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041104000</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STARING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>DOSAGE WAS TITRATED UP TO 75 MG</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519846-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20040704746</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>9.78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519847-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004NZ16033</companynumb>
    <primarysource>
      <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>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>450 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000717</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519848-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP14553</companynumb>
    <primarysource>
      <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 ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>50 MG/DAY</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519849-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040914</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB03468</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040714</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519850-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US11567</companynumb>
    <primarysource>
      <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>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>5 MG, Q6H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>800 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971119</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519851-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-239962</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>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugdosagetext>14IU A.M./6IU P.M.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN N</medicinalproduct>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
        <drugtreatmentduration>280</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugdosagetext>.25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
        <drugtreatmentduration>27360</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519852-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12871</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>100 MG, TWICE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEDICATION ERROR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERMITTENT CLAUDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519853-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12824</companynumb>
    <primarysource>
      <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>CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL HAEMOGLOBIN CONCENTRATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL VOLUME DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL ABNORMALITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>50MG QAM, 100MG QPM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519854-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041200308</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugdosagetext>(5-10 MG)</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519855-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB03709</companynumb>
    <primarysource>
      <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>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL HAEMOGLOBIN CONCENTRATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL VOLUME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>350MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
        <drugtreatmentduration>310</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANYLCYPROMINE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugdosagetext>54 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519856-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040625</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200412218JP</companynumb>
    <primarysource>
      <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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIINFLAMMATORY THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERSTITIAL LUNG DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERSTITIAL LUNG DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIINFLAMMATORY THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDRONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519857-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040825</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200412760JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZESULAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TATHION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519858-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419083US</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANZEMET</medicinalproduct>
        <drugbatchnumb>A4188</drugbatchnumb>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL /OLD FORM/</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519859-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200412673DE</companynumb>
    <primarysource>
      <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>RETINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALORON N</medicinalproduct>
        <drugdosagetext>DOSE: 50 / 8</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KREON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPIDIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519860-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413606JP</companynumb>
    <primarysource>
      <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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HACHIMIJIO-GAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARNAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UBRETID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SHAKUYAKUKANZOUTOU</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOKUNALIN</medicinalproduct>
        <drugadministrationroute>003</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYONAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugadministrationroute>003</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN SUPPOSITORIEN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
      </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>LIPOVAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519861-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414451FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE DEPLETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCHLORAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ALKALOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROVEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDIATOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUCALCIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519862-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419135US</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 4-8; FREQUENCY: BEFORE MEALS; DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519863-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421852GDDC</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030310</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519864-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5MG ; 1MG  ONCE ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugdosagetext>1 TAB BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519865-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040100462</companynumb>
    <primarysource>
      <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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011113</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011113</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519866-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEHISCENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>20MG  DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519867-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>3000 MG  DIVIDED BID  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADENOID CYSTIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>3000 MG  DIVIDED BID  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SALIVARY GLAND NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>228 MG  EVERY 3 WEEKS  INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ADENOID CYSTIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>228 MG  EVERY 3 WEEKS  INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SALIVARY GLAND NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ILOTYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMELOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARBEPOETIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519868-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugdosagetext>90MG  DAILY SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519869-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>PRN ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519870-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>20MG  DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
        <drugdosagetext>400MG DAILY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519871-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG  DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB  200MG   PFIZER</medicinalproduct>
        <drugdosagetext>200MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519872-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325MG  DAILY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugdosagetext>500MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519873-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.3586</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURITIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRAMUSTINE 140MG BID DAYS 1-5</medicinalproduct>
        <drugdosagetext>140MG BID DAY 1- BX6 WK ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>85-86MG DAY2X8WK6X INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICOPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NISEPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </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>LUPRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVIST D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519874-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>146 - 169 MG IV WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXEMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519875-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.7</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>AUC = 6.0 Q3 WKS INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>THYMOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>225 MG/M2 Q3 WKS INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>THYMOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO-NOVUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519876-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC EMBOLUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELSPAR</medicinalproduct>
        <drugbatchnumb>0B56N</drugbatchnumb>
        <drugdosagetext>13,800 U IM X 6 DOSES</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAUNOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519877-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40MG QHS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE N</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519878-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-AMGEN-US081414</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PILONIDAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020920</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519879-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98.4306</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUNISOLIDE  29 MCG</medicinalproduct>
        <drugbatchnumb>PROF SAMPLE</drugbatchnumb>
        <drugdosagetext>2 X'S DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519880-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTICAINE</medicinalproduct>
        <drugdosagetext>ONCE DENTAL</drugdosagetext>
        <drugadministrationroute>004</drugadministrationroute>
        <drugindication>TOOTH EXTRACTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519881-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACERONE</medicinalproduct>
        <drugdosagetext>800MG DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACERONE</medicinalproduct>
        <drugdosagetext>400 MG DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-OUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVANTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONALACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOMAZAPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519882-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugdosagetext>200MG  DAILY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040510</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519883-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>176.9028</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
        <drugdosagetext>1             PER DAY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
        <drugdosagetext>1             PER DAY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SWELLING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519884-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519885-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.8435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC FATIGUE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HORMONE LEVEL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF EMPLOYMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOTAL HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
        <drugdosagetext>1    DAY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19861102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19910610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>1      DAY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>1      DAY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVACOR-ERYTHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SONATA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519886-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGLE CLOSURE GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>TWICE  DAILY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041128</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519887-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>107.5025</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-MEDROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040610</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519888-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47.6277</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE   100MG/ML    LILLY</medicinalproduct>
        <drugdosagetext>1000MG/M2   DAY 1 + 15   INTRAVENOU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>20MG/M2   DAY 1 + 15   INTRAVENOU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</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>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519889-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE   UNKNOWN    UNKNOWN</medicinalproduct>
        <drugdosagetext>        DAILY    ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519890-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519891-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519892-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugbatchnumb>19-076-JT</drugbatchnumb>
        <drugdosagetext>500MG  Q 6 HRS INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIVERTICULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519893-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARM AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL CIRCULATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIAL PULSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>12.5MG   Q2 PRN  INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>12.5MG   Q2 PRN  INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IV DYE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519894-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEREDITARY OPTIC ATROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519895-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>3 MG  DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APAP TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISACODYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519896-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</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>IBUPROFEN</medicinalproduct>
        <drugdosagetext>200 MG TID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>200 MG TID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APAP TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519897-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</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>HEPARIN</medicinalproduct>
        <drugdosagetext>PROTOCOL    INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PHLEBOTHROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>PROTOCOL    INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SUPERIOR VENA CAVAL OCCLUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTOBACILLUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519898-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15635</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSPASM CORONARY</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 POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>5 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040331</drugenddate>
        <drugtreatmentduration>369</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040407</drugenddate>
        <drugtreatmentduration>379</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030330</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTCILLIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030330</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>8 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040331</drugenddate>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>60 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030331</drugenddate>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>72 MG/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040331</drugenddate>
        <drugtreatmentduration>372</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN</medicinalproduct>
        <drugdosagetext>2 TO 4 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030327</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030326</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519899-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004FR16123</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CD4 LYMPHOCYTES DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIRY CELL LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTOSTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519900-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ABBOTT-04P-083-0281699-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAMMONAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKIN TABLETS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKIN SOLUTION</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</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>UNASYN</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519901-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03474</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CREPITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDYFERON</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC /FRA/</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIPARINE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPRAM</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONICOR L.P.</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL ^BIOPHARMA^</medicinalproduct>
        <drugdosagetext>35 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>600 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
        <drugtreatmentduration>33120</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519902-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE233325NOV04</companynumb>
    <primarysource>
      <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>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALLORY-WEISS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>53</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519903-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04392</companynumb>
    <primarysource>
      <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>CARDIAC FLUTTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519904-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>109.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugdosagetext>75MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
        <drugdosagetext>25MG  DAILY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519905-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2004AU01672</companynumb>
    <primarysource>
      <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>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>800 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519906-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE242530NOV04</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519907-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE03954</companynumb>
    <primarysource>
      <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>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>25 OR 50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEDICATION ERROR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519908-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004CH16757</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031019</drugenddate>
        <drugtreatmentduration>902</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STUGERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DANCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519909-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>40MG  DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25MG  DAILY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519910-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10MG  DAILY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519911-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1000 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041128</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519912-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519913-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040804</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519914-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041007429</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519915-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041106062</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>LUNG TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519916-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041200719</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN HEARING LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519917-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041102784</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN M DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAPTOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOCET</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOCET</medicinalproduct>
        <drugindication>PROSTATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030215</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519918-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>800MG  DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519919-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>1 INHALATION  TWICE DAILY  RESPIRATORY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519920-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.298</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>18MCG   DAILY  RESPIRATORY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519921-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>0.25MG  DAILY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519922-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40.8237</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>1 A DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041009</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519923-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25MG   DAILY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>200MG   QID  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519924-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>600 MG  BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>10  MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KCL TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519925-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ROCHE-384478</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>GIVEN IN TWO DOSES OF 2000 MG AND 2150 MG DAILY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040912</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519926-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-351865</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030923</drugenddate>
        <drugtreatmentduration>197</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030924</drugenddate>
        <drugtreatmentduration>127</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519927-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030610</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-340049</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</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>FULL BLOOD COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUDGEMENT IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>STRENGTH REPORTED AS 180 MCG/0.5ML.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030914</drugenddate>
        <drugtreatmentduration>101</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030921</drugenddate>
        <drugtreatmentduration>108</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugdosagetext>DOSING REGIMEN REPORTED AS 1200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519928-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-387448</companynumb>
    <primarysource>
      <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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOPLASMA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
        <drugtreatmentduration>47</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEUKOCYTOSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519929-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ROCHE-386778</companynumb>
    <primarysource>
      <qualification>1</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREXAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRINETTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
        <drugtreatmentduration>302</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519930-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-385864</companynumb>
    <primarysource>
      <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYMPANIC MEMBRANE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>ROUTE REPORTED AS INJECTION.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519931-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-386223</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519932-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-370508</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031216</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECORTIN-H</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON</medicinalproduct>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519933-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-387359</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</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>CHEMICAL POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugdosagetext>DOSE FORM: INJECTABLE SOLUTION DOSAGE: 1/3 AMPULE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESFLURANE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIMBEX</medicinalproduct>
        <drugdosagetext>FORM: INJECTABLE SOLUTION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELOCURINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIOPENTAL SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>75MG OVER 5 MINUTES THEN 50MG/HOUR.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519934-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040721</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-375212</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040507</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040507</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugindication>NERVOUSNESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519935-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-385769</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF PRESSURE IN EAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>UNKNOWN BRAND.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040709</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519936-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-387318</companynumb>
    <primarysource>
      <qualification>5</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040723</drugenddate>
        <drugtreatmentduration>89</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040723</drugenddate>
        <drugtreatmentduration>89</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519937-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-387839</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040805</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IKOREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UREMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRITACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGOUT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KREDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519938-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-387508</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519939-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-387852</companynumb>
    <primarysource>
      <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>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519940-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-387780</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCAINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519941-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-387814</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </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>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOOCCLUSIVE LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLEXANE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYNORM</medicinalproduct>
        <drugdosagetext>PRN.</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>PRN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519942-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-387386</companynumb>
    <primarysource>
      <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>ABDOMINAL RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APRANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>IODINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CONTRAST MEDIA REACTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DATURA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANNABIS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040911</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519943-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ROCHE-387851</companynumb>
    <primarysource>
      <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>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL PHOBIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19890615</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910615</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519944-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG/10 MG AM/PM  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APAP TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519945-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-387997</companynumb>
    <primarysource>
      <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
        <drugtreatmentduration>231</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROHEPARUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULCERLMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040304</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519946-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>80 MG ONCE DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519947-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN INTRACRANIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugdosagetext>1 PATCH  ONCE A WEEK  EPIDURAL</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519948-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>VARIOUS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519949-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.4</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40MG,  40NG QPM, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOROLAC TROMETHAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN REG HUMAN 100 U/ML INJ NOVOLIN R</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN NPH NOVOLIN HUMAN INJ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN (ENTERIC-COATED) TAB,EC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACARBOSE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519950-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-NOVOPROD-240201</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>0</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKYLOGLOSSIA CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRESTED LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA NEONATAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID PENFILL 3.0 ML</medicinalproduct>
        <drugdosagetext>48 IU, QD</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTAPHAN PENFILL</medicinalproduct>
        <drugdosagetext>70 IU, QD</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSTINE</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>LABOUR INDUCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSTINE</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSTINE</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041024</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PETHIDINE</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN ^MAY + BAKER^</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTOCINON</medicinalproduct>
        <drugdosagetext>10 U, QD</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>1 L, QD</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROSE</medicinalproduct>
        <drugdosagetext>80 MG/KG/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZYLPENICILLIN</medicinalproduct>
        <drugdosagetext>UNK, SINGLE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCAINE</medicinalproduct>
        <drugdosagetext>3 ML, 0.5 %</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCAINE</medicinalproduct>
        <drugdosagetext>5 ML, 0.25 %</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>10 ML, 0.2%</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>2 UG/ML</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHIROCAINE</medicinalproduct>
        <drugdosagetext>.0625 %, UNK</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>1 G, SINGLE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>100 MG, PRN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>1.2 G, QD</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519951-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugdosagetext>900MG,  300MG TI, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNISOLIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519952-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>115.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519953-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-240730</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VULVAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VAGIFEM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519954-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00578</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBELLAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIAPRAXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040424</drugenddate>
        <drugtreatmentduration>543</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL COLUMN STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040424</drugenddate>
        <drugtreatmentduration>543</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL XINAFOATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CROMOLYN SODIUM AND REPROTEROL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519955-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00088</companynumb>
    <primarysource>
      <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</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041127</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTINEOPLASTIC (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519957-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04134</companynumb>
    <primarysource>
      <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>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA PNEUMOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUPRIMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519958-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0311USA02529</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST WALL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS NEUROSENSORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM POOR R-WAVE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA OF LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-CARDIAC CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS EXTERNA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QRS AXIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINITIS ATROPHIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO POSITIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519959-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>IV PIGGY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISACODYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE 7.5/ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORZOLAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIFICIAL TEARS POLYVINYL ALCOHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM CITRATE LIQUID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSPHATES ENEMA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519960-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>156 MGIV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519961-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.7403</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXANDRIN</medicinalproduct>
        <drugbatchnumb>429</drugbatchnumb>
        <drugdosagetext>10 MG BID</drugdosagetext>
        <drugindication>WEIGHT DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519962-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00236</companynumb>
    <primarysource>
      <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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519963-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA01025</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519964-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03751</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>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-CARDIAC CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519965-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519966-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0410USA01819</companynumb>
    <primarysource>
      <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>OPTIC DISC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VEIN OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041002</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519967-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04267</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519968-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>128</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519969-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519970-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00125</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519971-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04098</companynumb>
    <primarysource>
      <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 FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID AC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519972-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519973-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00795</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSIVE SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIC BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CLAUDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS SUPERFICIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO POSITIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OS-CAL D</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519974-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00875</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIBID DM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRA DS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN TABLETS/SUPPOSITORIES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZTROPINE MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519975-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04177</companynumb>
    <primarysource>
      <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>AORTIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519976-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03446</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519977-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03582</companynumb>
    <primarysource>
      <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>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>1088</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COMPRESSION FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>1088</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519978-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA04370</companynumb>
    <primarysource>
      <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>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519979-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>143.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN REGULAR U-100 INJ (HUMAN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519980-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04165</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN AND FOLIC ACID AND PYRIDOXINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519981-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0412USA00273</companynumb>
    <primarysource>
      <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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519982-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-NOVOPROD-240733</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN DETEMIR</medicinalproduct>
        <drugdosagetext>36 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>58 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519983-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-MERCK-0412NOR00006</companynumb>
    <primarysource>
      <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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030413</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519984-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00003</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519985-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00073</companynumb>
    <primarysource>
      <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 PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519986-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0412AUS00007</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519987-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00026</companynumb>
    <primarysource>
      <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>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041003</drugenddate>
        <drugtreatmentduration>557</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519988-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00101</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519989-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00008</companynumb>
    <primarysource>
      <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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519990-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04271</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519991-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00100</companynumb>
    <primarysource>
      <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</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519992-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041200595</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN STEM INFARCTION</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>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR DEMENTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519993-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041103911</companynumb>
    <primarysource>
      <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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519994-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105442</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>28.35</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRUXISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATIONS, MIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519995-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041201121</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>36.29</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519996-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00159</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519997-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00196</companynumb>
    <primarysource>
      <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>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519998-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00249</companynumb>
    <primarysource>
      <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>CONVULSION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040408</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4519999-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA04208</companynumb>
    <primarysource>
      <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>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSMEGEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIRARUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520000-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-MERCK-0412NOR00008</companynumb>
    <primarysource>
      <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>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC PROTRUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520001-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00255</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520002-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03580</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASOCONSTRICTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520003-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00232</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520004-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00306</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520005-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520006-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>137.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
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  <safetyreport>
    <safetyreportid>4520007-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
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    <companynumb>US-MERCK-0412USA00305</companynumb>
    <primarysource>
      <qualification>4</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520008-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SOLVAY-00304004166</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CREON</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520009-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-NOVOPROD-240751</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTRAPID</medicinalproduct>
        <drugdosagetext>6 IU, SINGLE</drugdosagetext>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520010-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>112</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520011-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520012-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520013-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520014-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPERIDINE INJ, SOLN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520015-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520016-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B PRECURSOR TYPE ACUTE LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520017-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
        <drugindication>HEPATIC NECROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
        <drugindication>HEPATITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESLORATIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520018-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041100729</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520019-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041106869</companynumb>
    <primarysource>
      <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 INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520020-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAIZEN</medicinalproduct>
        <drugdosagetext>2.8MG  NIGHTLY SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520021-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0412GBR00032</companynumb>
    <primarysource>
      <qualification>3</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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>104</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520022-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.4723</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO PERITONEUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN  1.25 MG/M2</medicinalproduct>
        <drugdosagetext>2.2 MG DAYS 1,2,3  INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>405  DAY 3 INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520023-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15409</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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 LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCHOL</medicinalproduct>
        <drugdosagetext>30 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041024</drugenddate>
        <drugtreatmentduration>30240</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERSANTIN</medicinalproduct>
        <drugdosagetext>300 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041024</drugenddate>
        <drugtreatmentduration>36000</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520025-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.1324</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXEMESTANE 25MG NCI</medicinalproduct>
        <drugdosagetext>25 MG DAILY ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLIDING SCALE INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520026-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE03975</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520027-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE03979</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520029-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03471</companynumb>
    <primarysource>
      <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>TAREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520031-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.1637</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugdosagetext>3.6 MG SC EVERY 4 WKS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugdosagetext>50 MG PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040816</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520032-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004SA16295</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIRUBIN CONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECHO VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUNIFEN</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>12.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520033-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12645</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IATROGENIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520034-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12697</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>160 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520035-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP14473</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>53280</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERSANTIN</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACECOL</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520040-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugindication>DISEASE PROGRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040206</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520046-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLEOMYCIN</medicinalproduct>
        <drugdosagetext>17.6 U IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>2.5 MG</drugdosagetext>
        <drugindication>HODGKIN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030904</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520049-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugdosagetext>14 MG / M2 D1 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXANOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520053-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>19.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMATOSIS CYSTOIDES INTESTINALIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>2.2 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARA-C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASPARGINASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520058-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12854</companynumb>
    <primarysource>
      <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>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>250 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520059-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03503</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRINIPATCH</medicinalproduct>
        <drugdosagetext>10 MG/24HRS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULINE NPH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUPRESSYL</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESIDRIX</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC                                /FRA/</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFU K</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTRAM</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTRAM</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugdosagetext>5 MG, BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520061-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>107.5025</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EROSIVE DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>1500MG/M2 3 WKS ON 1 WK OFF INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040528</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520062-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE03382</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUDIOMIL</medicinalproduct>
        <drugdosagetext>1 AMPOULE/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021114</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUDIOMIL</medicinalproduct>
        <drugdosagetext>2 AMPOULE/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021117</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUDIOMIL</medicinalproduct>
        <drugdosagetext>3 AMPOULE/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021119</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUDIOMIL</medicinalproduct>
        <drugdosagetext>4 AMPOULE/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021124</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUDIOMIL</medicinalproduct>
        <drugdosagetext>5 AMPOULE/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021202</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugdosagetext>37.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030216</drugenddate>
        <drugtreatmentduration>15840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUDIOMIL</medicinalproduct>
        <drugdosagetext>150 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030216</drugenddate>
        <drugtreatmentduration>77</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXILAN</medicinalproduct>
        <drugdosagetext>100 TO 150 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030217</drugenddate>
        <drugtreatmentduration>66240</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugdosagetext>20 TO 40 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030217</drugenddate>
        <drugtreatmentduration>76</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugdosagetext>3 TO 4 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021119</drugenddate>
        <drugtreatmentduration>21600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugdosagetext>2 TO 0.5 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021204</drugenddate>
        <drugtreatmentduration>21600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugdosagetext>3 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19710101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030304</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugdosagetext>75 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugdosagetext>150 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021106</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugdosagetext>75 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021111</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>2.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>7.5 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021114</drugenddate>
        <drugtreatmentduration>14400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLIOGEST ^RHONE-POULENC^</medicinalproduct>
        <drugdosagetext>1 TAB/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugdosagetext>25 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030203</drugenddate>
        <drugtreatmentduration>51840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugdosagetext>50 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030226</drugenddate>
        <drugtreatmentduration>33120</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACC</medicinalproduct>
        <drugdosagetext>1 TAB/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030217</drugenddate>
        <drugtreatmentduration>17280</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULCOGANT                                /GFR/</medicinalproduct>
        <drugdosagetext>20 ML/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030304</drugenddate>
        <drugtreatmentduration>21600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUXAL SUSPENSION</medicinalproduct>
        <drugdosagetext>5 TO 1.5 ML/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021126</drugenddate>
        <drugtreatmentduration>12960</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUXAL</medicinalproduct>
        <drugdosagetext>30 TO 90 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030103</drugenddate>
        <drugtreatmentduration>57600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUXAL</medicinalproduct>
        <drugdosagetext>60 TO 30 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030114</drugenddate>
        <drugtreatmentduration>15840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520067-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATORENAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>562.5MG/M2 QWX3 1WK O INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040713</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520070-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.5755</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB 200 MG SEARLE, PFIZER</medicinalproduct>
        <drugbatchnumb>C201383-RCT12499</drugbatchnumb>
        <drugdosagetext>400 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB 200 MG SEARLE, PFIZER</medicinalproduct>
        <drugbatchnumb>C201383-RCT12499</drugbatchnumb>
        <drugdosagetext>400 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520072-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004KR14563</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN E INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOALVEOLAR LAVAGE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY MEDIASTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>600 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520073-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15497</companynumb>
    <primarysource>
      <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>SINUS ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>800 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520075-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1000 MG/M2 IV Q WEEK X 7 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520081-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.8</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1000 MG/M2 Q WK X 7 WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040820</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520083-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12776530</companynumb>
    <primarysource>
      <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>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>1ST ADMINISTRATION: 22-OCT-04; 2ND ADMINISTRATION: 29-OCT-04</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520088-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-BRISTOL-MYERS SQUIBB COMPANY-12777025</companynumb>
    <primarysource>
      <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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABILE BLOOD PRESSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
        <drugtreatmentduration>324</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIROCORT</medicinalproduct>
        <drugdosagetext>INHALATION</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520089-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12721353</companynumb>
    <primarysource>
      <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>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GATIFLO TABS 100 MG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOLEBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN R</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVEN E-P</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE-A</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADONA</medicinalproduct>
        <drugdosagetext>INTERRUPTED FROM 19-FEB-2004 TO 03-SEP-2004</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID + PANTOTHENIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENOGLOBULIN-I</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040903</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RULID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520091-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12784294</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030508</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520093-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12783478</companynumb>
    <primarysource>
      <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>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030313</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520094-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12784153</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BILIRUBIN CONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugdosagetext>THERAPY INTERRUPTED ON 11/19/2004</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020708</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520096-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-12737805</companynumb>
    <primarysource>
      <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>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISCITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>PT HAD REC'D 15 TX TO DATE. DOSE DELAYED/THEN D/C'D ON 28-OCT-04 DUE TO PD</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugdosagetext>DOSE DELAYED/THEN DISCONTINUED DUE TO PD ON 28-OCT-04.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520097-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12784377</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugdosagetext>ONCE NIGHTLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugdosagetext>DOSAGE FORM: TABLET, ONCE DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520098-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040610</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12610960</companynumb>
    <primarysource>
      <qualification>2</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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTH ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040604</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>STARTED ON 7.0 MG DAILY, INCREASED TO 7.5 MG DAILY 25-MAY-2004.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040604</drugenddate>
        <drugtreatmentduration>241</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>DISCONTINUED DUE TO HIGH CPK LEVEL.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
        <drugdosagetext>DOSAGE FORM = TABLET</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520105-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-NOVOPROD-240636</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>24 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID FLEXPEN</medicinalproduct>
        <drugdosagetext>36 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STESOLID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STESOLID</medicinalproduct>
        <drugdosagetext>OVERDOSE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520113-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION MUCOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY RELATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040708</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520114-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.5964</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>650 MG/M2</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>650 MG/M2</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>650 MG/M2</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>400 MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>400 MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>400 MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520116-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEPESID</medicinalproduct>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLASETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520125-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.2867</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN</medicinalproduct>
        <drugbatchnumb>544854 (DAY 3)</drugbatchnumb>
        <drugdosagetext>90 MG/M2/DAY DAY 1,2,3</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugbatchnumb>57317A (DAY 5)</drugbatchnumb>
        <drugdosagetext>100 MG/M2/DAY DAYS 1-7</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAKACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRADE III MOUTHWASH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HABITROL 21</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERIDEX</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>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TULISATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520126-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004FI15420</companynumb>
    <primarysource>
      <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>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOARSENESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE BITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
        <drugindication>UVEITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VEXOL</medicinalproduct>
        <drugindication>UVEITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>21600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>7.5 MG/D</drugdosagetext>
        <drugindication>REITER'S SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXAN</medicinalproduct>
        <drugdosagetext>15 MG, QW</drugdosagetext>
        <drugindication>REITER'S SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520128-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004IT15323</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
        <drugtreatmentduration>249</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520129-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04432</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CSF CELL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520130-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>820 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugdosagetext>400 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOPTIC OPHTHALMIC EYE DROPS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520135-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>285</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN STEM SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>125 MGM IV X 1 DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>125 MG IV X 3 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520139-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugdosagetext>120 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugdosagetext>120 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugdosagetext>120 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>1200 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>1200 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>1200 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520145-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE03709</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520146-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>300 MG, IV Q 3 WK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>515 MG, IV, Q3 WK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520148-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BR15865</companynumb>
    <primarysource>
      <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>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APRESOLINE</medicinalproduct>
        <drugdosagetext>25 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520149-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040902</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP11806</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTA PRAEVIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRE-ECLAMPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APRESOLINE</medicinalproduct>
        <drugdosagetext>30 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREGNANCY INDUCED HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040829</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APRESOLINE</medicinalproduct>
        <drugdosagetext>50 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APRESOLINE</medicinalproduct>
        <drugdosagetext>60 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040902</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UTEMERIN</medicinalproduct>
        <drugdosagetext>40 TO 30 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040902</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RINDERON</medicinalproduct>
        <drugdosagetext>12 MG/DAY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RINDERON</medicinalproduct>
        <drugdosagetext>60 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040902</drugenddate>
        <drugtreatmentduration>12960</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520152-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520161-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-240785</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID 30 MIX CHU FLEXPEN</medicinalproduct>
        <drugbatchnumb>N/A</drugbatchnumb>
        <drugdosagetext>8 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>222</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID CHU</medicinalproduct>
        <drugbatchnumb>N/A</drugbatchnumb>
        <drugdosagetext>5 - 14 IU QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>244</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTRIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KINEDAK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520163-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.3482</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHAXOZOLE 800 MG/TMP 16 MG</medicinalproduct>
        <drugdosagetext>ONE BID X 10 DAYS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520172-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>ONE PO BID X 1 DAY THEN DAILY X 4 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520178-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.0906</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE 200 MG/TMP 160 G</medicinalproduct>
        <drugdosagetext>ONE TWICE DAILY</drugdosagetext>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IODINE FOR DRESSING CHANGE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520182-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.3273</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETH 800/TMP 160 MG</medicinalproduct>
        <drugdosagetext>ONE PO BID X 14 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520190-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>10 MG PO QD/11/4/2004 @5AM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520194-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>8840 SYNCHRONMED B 8627-18 18 ML W SIDE PORT MEDTRONIC</medicinalproduct>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MSCL 65.0 MG/ML</medicinalproduct>
        <drugdosagetext>19 MG DAY INTRATHECA</drugdosagetext>
        <drugadministrationroute>039</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520197-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>31.7518</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugindication>DRUG HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520203-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB  375 MG/M2  GENENTECH</medicinalproduct>
        <drugdosagetext>375 MG/M2  ONCE/WEEK X 4 INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALGANCICLOVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520206-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugdosagetext>50  MG X 1 INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugdosagetext>50  MG X 1 INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>.25 MG  X 1 INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>.25 MG  X 1 INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAPHYLACTIC RXN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520209-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12705018</companynumb>
    <primarysource>
      <qualification>3</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>ACUTE LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT RELATED SECONDARY MALIGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDREA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYCYTHAEMIA VERA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010201</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520210-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugdosagetext>9 MCG/KG  (900MCG SC 1X WKLY)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugdosagetext>9 MCG/KG  (900MCG SC 1X WKLY)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GROWTH COLONY STIMULATING FACTOR (G-CSF)</medicinalproduct>
        <drugdosagetext>2.5 MCG/KG (250 MCG SC 2X WKLY)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040828</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GROWTH COLONY STIMULATING FACTOR (G-CSF)</medicinalproduct>
        <drugdosagetext>2.5 MCG/KG (250 MCG SC 2X WKLY)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040828</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520213-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IR-BRISTOL-MYERS SQUIBB COMPANY-12776365</companynumb>
    <primarysource>
      <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>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>OVARIAN DYSGERMINOMA STAGE II</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLEOMYCIN</medicinalproduct>
        <drugindication>OVARIAN DYSGERMINOMA STAGE II</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINBLASTINE SULFATE</medicinalproduct>
        <drugindication>OVARIAN DYSGERMINOMA STAGE II</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520214-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugdosagetext>9 MCG/KG  (900 MCG SC 1X WKLY)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugdosagetext>9 MCG/KG  (900 MCG SC 1X WKLY)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GROWTH COLONY STIMULATING FACTOR (G-CSF)</medicinalproduct>
        <drugdosagetext>2.5 MCG/KG (250 MCG SC 2X WKLY)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040828</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GROWTH COLONY STIMULATING FACTOR (G-CSF)</medicinalproduct>
        <drugdosagetext>2.5 MCG/KG (250 MCG SC 2X WKLY)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040828</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520216-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12780698</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE NODULAR SCLEROSIS STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE NODULAR SCLEROSIS STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE NODULAR SCLEROSIS STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE NODULAR SCLEROSIS STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARA-C</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE NODULAR SCLEROSIS STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE NODULAR SCLEROSIS STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520218-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12780789</companynumb>
    <primarysource>
      <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>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARA-C</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520219-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12782462</companynumb>
    <primarysource>
      <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>IDIOPATHIC PNEUMONIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE NODULAR SCLEROSIS STAGE III</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE NODULAR SCLEROSIS STAGE III</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE NODULAR SCLEROSIS STAGE III</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ALLOGENIC BONE MARROW TRANSPLANTATION THERAPY</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ALLOGENIC BONE MARROW TRANSPLANTATION THERAPY</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARMUSTINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ALLOGENIC BONE MARROW TRANSPLANTATION THERAPY</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE NODULAR SCLEROSIS STAGE III</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARA-C</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE NODULAR SCLEROSIS STAGE III</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE NODULAR SCLEROSIS STAGE III</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEM CELL TRANSPLANTATION</medicinalproduct>
        <drugindication>HODGKIN'S DISEASE NODULAR SCLEROSIS STAGE III</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugdosagetext>CGY</drugdosagetext>
        <drugindication>HODGKIN'S DISEASE NODULAR SCLEROSIS STAGE III</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520221-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12782546</companynumb>
    <primarysource>
      <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>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>AUTOLOGOUS BONE MARROW TRANSPLANTATION THERAPY</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>AUTOLOGOUS BONE MARROW TRANSPLANTATION THERAPY</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARMUSTINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>AUTOLOGOUS BONE MARROW TRANSPLANTATION THERAPY</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARA-C</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEM CELL TRANSPLANTATION</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520222-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12782686</companynumb>
    <primarysource>
      <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>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>AUTOLOGOUS BONE MARROW TRANSPLANTATION THERAPY</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>AUTOLOGOUS BONE MARROW TRANSPLANTATION THERAPY</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARMUSTINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>AUTOLOGOUS BONE MARROW TRANSPLANTATION THERAPY</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARA-C</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEM CELL TRANSPLANTATION</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520223-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCESSIVE GRANULATION TISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS EXTERNA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugdosagetext>9MCG/KG (730 MCG SC Q WKLY)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugdosagetext>9MCG/KG (730 MCG SC Q WKLY)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GROWTH COLONY STIMULATING FACTOR (G-CSF)</medicinalproduct>
        <drugdosagetext>2.5 MCG/KG (200 MCG SC 2X WKLY)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GROWTH COLONY STIMULATING FACTOR (G-CSF)</medicinalproduct>
        <drugdosagetext>2.5 MCG/KG (200 MCG SC 2X WKLY)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESFERAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520225-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004PL16325</companynumb>
    <primarysource>
      <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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>75 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PERSONALITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520231-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugdosagetext>4.5 MCG/KG - 9.0 MCG/KG 1X WKLY</drugdosagetext>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugdosagetext>4.5 MCG/KG - 9.0 MCG/KG 1X WKLY</drugdosagetext>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GROWTH COLONY STIMULATING FACTOR (G-CSF)</medicinalproduct>
        <drugdosagetext>2.5 MCG/KG  (205 MCG SC 2X WKLY)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GROWTH COLONY STIMULATING FACTOR (G-CSF)</medicinalproduct>
        <drugdosagetext>2.5 MCG/KG  (205 MCG SC 2X WKLY)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520233-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004PL16334</companynumb>
    <primarysource>
      <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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>750 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PERSONALITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520235-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004PL16339</companynumb>
    <primarysource>
      <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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>800 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520236-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04407</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520237-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004FI14982</companynumb>
    <primarysource>
      <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>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHANOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHARCOAL, ACTIVATED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugdosagetext>200 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugdosagetext>UNK, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520239-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12786000</companynumb>
    <primarysource>
      <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>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT RELATED SECONDARY MALIGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520240-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT  50</medicinalproduct>
        <drugdosagetext>50 MG  2X/WEEK  SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040506</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520249-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL FAECES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>100 MCG QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>100 MCG QD</drugdosagetext>
        <drugindication>HYPERTHYROIDISM</drugindication>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520251-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.7298</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAMARIUM</medicinalproduct>
        <drugdosagetext>1MCI/KG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAMARIUM</medicinalproduct>
        <drugdosagetext>1MCI/KG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520262-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520266-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>803</patientonsetageunit>
      <patientweight>4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORFADIN NOVAFACTOR</medicinalproduct>
        <drugdosagetext>1 MG/KG/DY PO 1</drugdosagetext>
        <drugindication>TYROSINAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORFADIN NOVAFACTOR</medicinalproduct>
        <drugdosagetext>1 MG/KG/DY PO 1</drugdosagetext>
        <drugindication>TYROSINAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520269-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARBOPOETIN ALFA</medicinalproduct>
        <drugdosagetext>9 MCG/KG (900 MCG SC Q WEDNESDAY)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>2.5 MG/HR (250 MG SC Q WEDNESDAY + SATURDAY)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040828</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFEN OC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520275-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.3899</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITTING OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>1.3 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>1.3 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>1.3 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>2.3 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520282-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.4624</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugdosagetext> 20 MG  PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugdosagetext> 20 MG  PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SOCIAL PHOBIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520284-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20011109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2001DE02629</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASEPTIC NECROSIS BONE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520286-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004IT16767</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL TEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS DETACHMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520288-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</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>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>250 / 50 1 BID</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520294-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL THROMBOSIS LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugindication>RECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugindication>RECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520300-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.7716</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF PRESSURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugdosagetext>2 X PER DAY</drugdosagetext>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520302-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>CYTOXAN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENEKOT-S</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520303-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-10-1106</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AERIUS DESLORATADINE) ^LIKE CLARINEX^</medicinalproduct>
        <drugauthorizationnumb>21165</drugauthorizationnumb>
        <drugdosagetext>10 ML/DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520304-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.9874</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIGALL</medicinalproduct>
        <drugdosagetext>300 MG PO TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BILIARY CIRRHOSIS PRIMARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520306-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1093</companynumb>
    <primarysource>
      <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>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN SULFATE</medicinalproduct>
        <drugauthorizationnumb>50039</drugauthorizationnumb>
        <drugdosagetext>20 MG INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MENINGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFUROXAZIDE SYRUP</medicinalproduct>
        <drugdosagetext>TID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORPHENIRAMINE MALEATE</medicinalproduct>
        <drugdosagetext>1 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BROMHEXINE</medicinalproduct>
        <drugdosagetext>2 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520308-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_25441_2004</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL HAEMOGLOBIN CONCENTRATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugauthorizationnumb>17794</drugauthorizationnumb>
        <drugdosagetext>DF ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUNITRAZEPAM</medicinalproduct>
        <drugdosagetext>80 TAB ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>3 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUNITRAZEPAM</medicinalproduct>
        <drugdosagetext>4 MG Q DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>75 MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>75 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>75 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>75 MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520310-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0373895A</companynumb>
    <primarysource>
      <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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520311-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200409184</companynumb>
    <primarysource></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>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STREPTASE</medicinalproduct>
        <drugbatchnumb>28726011E</drugbatchnumb>
        <drugdosagetext>1.5 MIU DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRENALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520312-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</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>GLUCOVANCE</medicinalproduct>
        <drugdosagetext>GREATER THAN 6 MONTHS</drugdosagetext>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520313-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_60441_2004</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYSOLINE</medicinalproduct>
        <drugauthorizationnumb>9170</drugauthorizationnumb>
        <drugdosagetext>1000 MG QDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TREMOR</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASASANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOKET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520314-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-044-0281766-00</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTOTHAL</medicinalproduct>
        <drugdosagetext>SEE IMAGE. INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVE PILLS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAIN KILLERS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520315-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CAN-2004-0000216</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYSUBSTANCE ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>SEE TEXT</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>SEE TEXT</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL (ETHANOL)</medicinalproduct>
        <drugdosagetext>SEE TEXT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COCAINE (COCAINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520316-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRP04001000</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugauthorizationnumb>20835</drugauthorizationnumb>
        <drugdosagetext>35  MG, 1/WEEK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugdosagetext>150 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYARTERITIS NODOSA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT 1000 (CALCIUM CARBONATE) EFFERVESCENT TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520317-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0416350A</companynumb>
    <primarysource>
      <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>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANCER PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4MG IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AXID</medicinalproduct>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugdosagetext>25MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HYCLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE-SR</medicinalproduct>
        <drugdosagetext>300MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
        <drugdosagetext>25MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>2PUFF AS REQUIRED</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugdosagetext>2PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520318-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040528</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A03200400600</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>5MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031022</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031015</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520319-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0526841A</companynumb>
    <primarysource>
      <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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUMATRIPTAN SUCCINATE</medicinalproduct>
        <drugdosagetext>6MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040428</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPYLTHIOURACIL</medicinalproduct>
        <drugindication>HYPERTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520320-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040924</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0527571A</companynumb>
    <primarysource>
      <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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULTRASOUND SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>2TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>6CAP PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040518</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520321-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0533637A</companynumb>
    <primarysource>
      <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>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520322-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0533792A</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>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINORELBINE TARTRATE</medicinalproduct>
        <drugdosagetext>48MG CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
        <drugtreatmentduration>246</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1900MG CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
        <drugtreatmentduration>246</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520323-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0534531A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520324-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0535037A</companynumb>
    <primarysource>
      <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>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520325-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535071A</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>0.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041024</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugdosagetext>625MG TWICE PER DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041024</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520326-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>UKP04000443</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP AND/OR ORAL CAVITY CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugauthorizationnumb>19651</drugauthorizationnumb>
        <drugdosagetext>400 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520327-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535565A</companynumb>
    <primarysource>
      <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>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520328-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535571A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520329-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535593A</companynumb>
    <primarysource>
      <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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520330-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535881A</companynumb>
    <primarysource>
      <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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520331-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536071A</companynumb>
    <primarysource>
      <qualification>5</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>8MG IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001103</drugenddate>
        <drugtreatmentduration>445</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE HCL</medicinalproduct>
        <drugdosagetext>100MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugdosagetext>2PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>300MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLENDIL</medicinalproduct>
        <drugdosagetext>20MG IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520332-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536076A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520333-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536198A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520334-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0333924A</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040412</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugdosagetext>1.5UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040412</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETAZIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEBRIDAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMPAVAGOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520335-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0347027A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030404</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSENN</medicinalproduct>
        <drugdosagetext>.5G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RACOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANOREXIA NERVOSA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030311</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520336-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0349430A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLALIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERYCIT</medicinalproduct>
        <drugdosagetext>750MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLCOBAL</medicinalproduct>
        <drugdosagetext>1500MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN S</medicinalproduct>
        <drugdosagetext>50MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PHOSPHORUS INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugdosagetext>22.5G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PHOSPHORUS INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADONA (AC-17)</medicinalproduct>
        <drugdosagetext>90MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RETINAL HAEMORRHAGE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520337-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004JP001901</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43.8</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>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAWACILLIN</medicinalproduct>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIPOLAZIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTOMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOLVON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520338-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0351251A</companynumb>
    <primarysource>
      <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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCULUS URINARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIXIVAN</medicinalproduct>
        <drugdosagetext>1200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031202</drugenddate>
        <drugtreatmentduration>210</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520339-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0351252A</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>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STOCRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMATIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVOXAC</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAMIDINE ISETIONATE</medicinalproduct>
        <drugdosagetext>100MG IN THE MORNING</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040123</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520340-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0358118A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM REPOLARISATION ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR SULFATE + LAMIVUDINE</medicinalproduct>
        <drugdosagetext>900MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GW433908</medicinalproduct>
        <drugdosagetext>700MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugdosagetext>100MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-TRIMOXAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520341-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0358403A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugdosagetext>20MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
        <drugtreatmentduration>469</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERBUTALINE</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEBEVERINE</medicinalproduct>
        <drugdosagetext>135MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>5MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLINE SALICYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520342-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0358408A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugdosagetext>500MG SIX TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABNORMAL FAECES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELITREX</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041003</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABNORMAL FAECES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOXID</medicinalproduct>
        <drugdosagetext>600MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABNORMAL FAECES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OFLOCET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ABNORMAL FAECES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520343-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GLAXOSMITHKLINE-B0358444A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLOSSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMAN INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLOSSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520344-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>12411757</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031015</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520345-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-GLAXOSMITHKLINE-B0358760A</companynumb>
    <primarysource>
      <qualification>1</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>AVANDIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520346-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-GLAXOSMITHKLINE-B0358861A</companynumb>
    <primarysource>
      <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>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYCAMTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040906</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520347-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-GLAXOSMITHKLINE-B0358932A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>041</drugbatchnumb>
        <drugdosagetext>4MG UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBETIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520348-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-GLAXOSMITHKLINE-B0358983A</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>200MG IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520349-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>25935</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYPTORCHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE + ZIDOVUDINE</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
        <drugtreatmentduration>124</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
        <drugdosagetext>2500MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
        <drugtreatmentduration>124</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPINAVIR + RITONAVIR</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520350-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-GLAXOSMITHKLINE-B0359055A</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>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520351-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-GLAXOSMITHKLINE-B0359147A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520352-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-GLAXOSMITHKLINE-B0359152A</companynumb>
    <primarysource>
      <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>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBOTHROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STOCRIN</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENITEC</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>3.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520353-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04.090-PRES-FRA</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PEMPHIGOID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRESTOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FONLIPOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KENZEN</medicinalproduct>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPA</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDIATENSYL</medicinalproduct>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520354-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03493</companynumb>
    <primarysource>
      <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>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRACTAL</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520355-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6010781F</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
        <drugdosagetext>500 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520356-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03494</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUTURE INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRACTAL</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520358-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004SI03803</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCOL</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040724</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520359-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASTICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>300 MG PO TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHIC PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520360-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2004--07597</companynumb>
    <primarysource>
      <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040715</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520362-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2004-07107</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTREMITY NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMORAL NECK FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM OF AMPULLA OF VATER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION ENTEROCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520364-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-US2004-08167</companynumb>
    <primarysource>
      <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>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520366-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004RL000136</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED SELF-CARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RYTHMOL (PROPAFENONE) HYDROCHLORIDE) (150 MG)</medicinalproduct>
        <drugauthorizationnumb>19151</drugauthorizationnumb>
        <drugdosagetext>450 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>..</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>..</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520367-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CA15862</companynumb>
    <primarysource>
      <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>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN BREAST NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIAL ABLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADOT</medicinalproduct>
        <drugdosagetext>50 UG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugdosagetext>50 UG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520369-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12910</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520370-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004242130FR</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOMEFLOXACIN HYDROCHLORIDE TABLET (LOMEFLOXACIN HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>20013</drugauthorizationnumb>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE (AMIODARONE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE (AMIODARONE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EXTRASYSTOLES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLECALCIFEROL (COLECALCIFEROL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520372-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2004-07628</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</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>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN (VALSARTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL (ACENOCOUMAROL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520377-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12785408</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520378-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12784559</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520379-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT</medicinalproduct>
        <drugindication>MENSTRUAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010510</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520380-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</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>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DESQUAMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>125MCG  DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>112MCG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520381-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004240091GB</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAREL SPRAY (NAFARELIN ACETATE)</medicinalproduct>
        <drugauthorizationnumb>19886</drugauthorizationnumb>
        <drugdosagetext>NASAL</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>IN VITRO FERTILISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GONAL-F</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOGEST ^COLLINS^ (PROGESTERONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GONADOTROPHIN CHORIONIC (CHORIONIC GONADOTROPHIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520383-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>91MG  24HR X 3 DAYS INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>1190  30MIN X 3 DAYS  INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520385-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ST-2004-008145</companynumb>
    <primarysource>
      <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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugauthorizationnumb>21286</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>8 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>4 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIBACEN</medicinalproduct>
        <drugdosagetext>5 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYLORIC ^GLAXO WELLCOME^</medicinalproduct>
        <drugdosagetext>100 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPTORUNA</medicinalproduct>
        <drugdosagetext>12.5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TSURUDEK</medicinalproduct>
        <drugdosagetext>150 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STOMACH DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABAGIN</medicinalproduct>
        <drugdosagetext>1 DF TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STOMACH DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROPEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARNAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMESGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COBALAT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520386-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.2971</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugdosagetext>20  MG BID  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520388-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099269</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520391-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004243165JP</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONSILLAR ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN PHOSPHATE SOLUTION, STERILE (CLINDAMYCIN PHOSPHATE)</medicinalproduct>
        <drugauthorizationnumb>62803</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNASYN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE MALEATE</medicinalproduct>
        <drugdosagetext>150 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM (LOXOPROFEN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE MALEATE (LEVOMEPROMAZINE MALEATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520392-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93.441</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520393-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041106283</companynumb>
    <primarysource>
      <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>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL (ETHANOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520394-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.7913</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>50MG  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugbatchnumb>P7169</drugbatchnumb>
        <drugdosagetext>25  MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520395-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041106270</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>11.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>19842</drugauthorizationnumb>
        <drugdosagetext>5 ML, 2 IN 1 TOTAL, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520396-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097411</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE TABLET (SULFASALAZINE)</medicinalproduct>
        <drugauthorizationnumb>7073</drugauthorizationnumb>
        <drugdosagetext>(500 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040710</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520397-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.3586</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>10 MG/KG IV Q 2 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1000 MG/M2</drugdosagetext>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>85 MG/M2</drugdosagetext>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520398-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097398</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY DYSMORPHIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN (SOMATROPIN)</medicinalproduct>
        <drugauthorizationnumb>20280</drugauthorizationnumb>
        <drugdosagetext>0.5 MG (0.5 MG, DAILY  INTERVAL: EVERY DAY), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMOCRIPTINE MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE (LEVOTHYROXINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520399-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520400-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004095318</companynumb>
    <primarysource>
      <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>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520401-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003156414DE</companynumb>
    <primarysource>
      <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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN POWDER, STERILE (SOMATROPIN)</medicinalproduct>
        <drugauthorizationnumb>20280</drugauthorizationnumb>
        <drugdosagetext>0.3 MG, SUBCUTANEOUS; 0.2 MG, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN POWDER, STERILE (SOMATROPIN)</medicinalproduct>
        <drugauthorizationnumb>20280</drugauthorizationnumb>
        <drugdosagetext>0.3 MG, SUBCUTANEOUS; 0.2 MG, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520402-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>107.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugdosagetext>150MG  2 X DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041203</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520403-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004093988</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>11.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN POWDER, STERILE (SOMATROPIN)</medicinalproduct>
        <drugauthorizationnumb>20280</drugauthorizationnumb>
        <drugdosagetext>0.4 MG, INJECTET SIX DAY/WEEKLY), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030414</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520404-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.0604</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ELECTROLYTES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FANCONI SYNDROME ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR   300MG  GILEAD SCIENCES</medicinalproduct>
        <drugdosagetext>300MG  QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPINAVIR-RITONAVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASAL FLUNISOLIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIRETINOIN/HYDROQUINONE CREAMS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520405-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097190</companynumb>
    <primarysource></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>CARDURA XL</medicinalproduct>
        <drugauthorizationnumb>19668</drugauthorizationnumb>
        <drugdosagetext>4 MG (4 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520406-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004095874</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST NEGATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>50784</drugauthorizationnumb>
        <drugdosagetext>500 MG (1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOCISTEINE (CARBOCISTEINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520407-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51.2565</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520408-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097832</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MINERAL DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugauthorizationnumb>18482</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520409-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL PULMONARY VALVE ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPEREMESIS GRAVIDARUM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030831</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520410-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097842</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT BELOW NORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LATE DEVELOPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT GAIN POOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN (NEURONTIN)</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOBAZAM (CLOBAZAM)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520411-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207783</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520412-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>1PILL  DAY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>1PILL  DAY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520413-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004081134</companynumb>
    <primarysource>
      <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>ALKALOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FELDENE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB (CELECOXIB)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520414-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.2554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugdosagetext>2MG  2  DAY SUBLINGUAL</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040731</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520415-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.5547</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF LIBIDO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>25 MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041204</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520416-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097200</companynumb>
    <primarysource>
      <qualification>3</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>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>900 MG (900 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHIC PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520417-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>36.2878</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520418-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004081132</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520419-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099114</companynumb>
    <primarysource>
      <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>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORTIS (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>40 MG (40 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENPROCOUMON (PHENPROCOUMON)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LERCANIDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520420-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL   50MG TABS    EON</medicinalproduct>
        <drugdosagetext>125MG   BID   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL   50MG TABS    EON</medicinalproduct>
        <drugdosagetext>125MG   BID   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOFASCIAL PAIN SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520421-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098710</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSPHENYTOIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>20450</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STATUS EPILEPTICUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFUROXIME</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520422-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-537</companynumb>
    <primarysource>
      <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>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>2 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520423-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207932</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>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRENTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROBION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILENA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN COMPLEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520424-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.905</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1500 MG/M2 IV OVER 150 MIN Q WEEK X 3 WEEKS FOLLOWED BY 1WEEK REST - TX UNTIL DZ PROGRESSIO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520425-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-553</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>6 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METALCAPTASE (PENICILLAMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABOAL - SLOW RELEASE (DICLOFENAC SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL (ALFACALCIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520426-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.5442</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>400 MG 2 BID</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>400 MG 2 BID</drugdosagetext>
        <drugindication>TUBEROUS SCLEROSIS</drugindication>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520427-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</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>MESTINON</medicinalproduct>
        <drugdosagetext>3 Q 3 HR # 800</drugdosagetext>
        <drugindication>MYASTHENIA GRAVIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520428-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-0007135</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS B POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRICITABINE (EMTRICITABINE) (TABLET)</medicinalproduct>
        <drugauthorizationnumb>21500</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE (TENOFOVIR DISOPROXIL FUMARATE) (TABLET)</medicinalproduct>
        <drugdosagetext>300 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPINAVIR/RITONAVIR (KALETRA) (CAPSULE)</medicinalproduct>
        <drugdosagetext>1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520429-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>J081-002-001786</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>39.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN (WARFARIN POTASSIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FASTIC (NATEGLINIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTIDE (FLUTICASONE PROPIONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIPHYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERSANTIN-L (DIPYRIDAMOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARAMIDIN (BUCOLOME)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANZIEF (ALLOPURINOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL (ALFACALCIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM LACTATE (CALCIUM LACTATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520430-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.7924</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRIPLE VESSEL BYPASS GRAFT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>12.5 - 1 PER DAY</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520431-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>J081-002-001703</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL CIRCULATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC (ALLOPURINOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520432-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A044-002-004934</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040325</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOLSIDOMINE (MOLSIDOMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC (ACTYLSALICYLATE LYSINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520433-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-0007567</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANION GAP INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugauthorizationnumb>21356</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIXIVAN</medicinalproduct>
        <drugdosagetext>800 MG, 1 IN 1D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520434-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE227123NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIPSYCHOTIC DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM REPOLARISATION ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTOLIC HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>50 MG 3X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>50 MG 3X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR II DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR II DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE (ZOPICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520435-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2002-UK-00282UK</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD INSULIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE (EU/1/97/055/001) (NEVIRAPINE) (NR)</medicinalproduct>
        <drugauthorizationnumb>20636</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG) IU</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR SULPHATE (NR)</medicinalproduct>
        <drugdosagetext>300 MG TWICE DAILY (300 MG, TWICE DAILY) IU</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugdosagetext>250 MG TWICE DAILY (250 MG, TWICE DAILY)) IU</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugdosagetext>40 MG TWICE DAILY (40 MG, TWICE DAILY) IU</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugdosagetext>200 MG TWICE DAILY (, TWICE DAILY) IU</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRIN (BACTRIM) (NR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS FULPHATE ANHYDROUS (FERROUS SULFATE) (NR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROSE MONOHYDRATE (NR)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520436-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-UK-00961UK</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugdosagetext>80 MG (NR) PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
        <drugdosagetext>IO</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520437-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-UK-01227UK</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
        <drugauthorizationnumb>12836</drugauthorizationnumb>
        <drugdosagetext>400 MG (, TWICE DAILY) PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040220</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG (, ONCE DAILY) PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040220</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE (SERTRALINE) (NR)</medicinalproduct>
        <drugdosagetext>100 MG (, ONCE DAILY) PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEBEVERINE (MEBEVERINE) (NR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL (PARACETAMOL) (NR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMPLE LINCTUS (SIMPLE LINCTUS) (NR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE (PROCHLORPERAZINE) (NR)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520438-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12113NB</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugauthorizationnumb>20938</drugauthorizationnumb>
        <drugdosagetext>10 MG (NR) PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
        <drugtreatmentduration>215</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLON (SOFALCONE)</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIMICRON (GLICLAZIDE) (TA)</medicinalproduct>
        <drugdosagetext>(40 MG) PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SELBEX (TEPRENONE)</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GASTER (FAMOTIDINE)</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520439-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-DE-05282DE</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugdosagetext>(18 MCG) IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520441-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040902</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-0007191</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.6173</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIUM AVIUM COMPLEX INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRICITABINE (EMTRICITABINE)</medicinalproduct>
        <drugauthorizationnumb>21500</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE (TENOFOVIR DISOPROXIL FUMARATE)</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAIDS (NSAID'S)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL (ETHAMBUTOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCELEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520442-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-0007496</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALCOHOL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRICITABINE (EMTRICITABINE)</medicinalproduct>
        <drugauthorizationnumb>21500</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOMATROPINE (HOMATROPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDFORTE (PREDNISOLONE ACETATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL D3 (OYSTER SHELL CALCIUM WITH VITAMIN D)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE (METHADONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN (AMOXICILLIN W/CLAVULANATE POTASSIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEOCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520443-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04120043</companynumb>
    <primarysource>
      <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 POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520444-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04110527</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520446-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-DE-05853GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND CODEINE PHOSPHATE</medicinalproduct>
        <drugauthorizationnumb>86366</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM-BROMIDE+SALBUTAMOL (COMBIVENT) (SALBUTAMOL, IPRATROPIUM-BR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN (DOXEPIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL (CLOPIDOGREL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520447-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-11825RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugauthorizationnumb>17812</drugauthorizationnumb>
        <drugdosagetext>1500 MG QHS (300 MG, 5 IN 1 D), PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON (IRON)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520448-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-05603-01</companynumb>
    <primarysource>
      <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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY ASPHYXIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>20 MG QAM PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520450-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-07554-01</companynumb>
    <primarysource>
      <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>NEOPLASM RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040706</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520453-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE681724NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031231</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031231</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520454-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE645523NOV04</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FULL BLOOD COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDERAL LA</medicinalproduct>
        <drugauthorizationnumb>18553</drugauthorizationnumb>
        <drugdosagetext>120 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDERAL LA</medicinalproduct>
        <drugauthorizationnumb>18553</drugauthorizationnumb>
        <drugdosagetext>120 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH (FISH OIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEVERFEW (HERBAL EXTRACTS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NOS (VITAMINS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE W/CHONDROITIN SULFATES (ASCORBIC ACIC/CHONDROITIN SULFATE/</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520455-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE309809NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugbatchnumb>2003P1480</drugbatchnumb>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugbatchnumb>2003P1480</drugbatchnumb>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugbatchnumb>2003P1038</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS, PLAIN (MULTIVITAMINS, PLAIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSPHORUS (PHOSPHORUS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT (ERYTHROPOIETIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520456-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000078</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520457-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096195</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520458-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE681824NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA OF CHRONIC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIRENAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>4 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF (TACROLIMUS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520461-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE683824NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41.31</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF (TACROLIMUS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520463-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OPD-2004-005</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>10</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORAPRED</medicinalproduct>
        <drugauthorizationnumb>75117</drugauthorizationnumb>
        <drugdosagetext>VARIABLE ML, TWICE, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY DISTRESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520466-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004058234</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.5036</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE (AMIODARONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM (PHENYTOIN SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520468-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE405228AUG03</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLLAGEN-VASCULAR DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL TEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VEIN OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINOPATHY PROLIFERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>4782</drugauthorizationnumb>
        <drugdosagetext>0.9 INITIALLY; VARIED IN DOSAGE FROM ^.3 MM TO .9 MM^, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESTROGEN REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19931001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESTROGEN REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATAB</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESTROGEN REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED CALCIUM SUPPLEMENT (UNSPECIFIED CALCIUM SUPPLEMENT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520470-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097957</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugauthorizationnumb>19949</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>12 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITRUS PARADISI FRUIT JUICE (CITRUS PARADISI FRUIT JUICE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENTERMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520471-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097581</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOCUTANEOUS CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugauthorizationnumb>19949</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>2 IN 1 D, INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>2 IN 1 D, INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM (MONTELUKAST SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN (VALSARTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPHTHALMOLOGICALS (OPHTHALMOLOGICALS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520472-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004078726</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.2971</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COUNTERFEIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>25 MG (25 MG, AS NECESSARY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520473-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-517</companynumb>
    <primarysource></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>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>7.5 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520474-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-515</companynumb>
    <primarysource></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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>10 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520475-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-511</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>15 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>20 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMX (ALENDRONATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON (IRON)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520476-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207156</companynumb>
    <primarysource>
      <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>LUMBAR RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P30086</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030919</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520477-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097960</companynumb>
    <primarysource></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>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONDITION AGGRAVATED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANTS (ANTIDEPRESSANTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANXIOLYTIC (ANXYOLYTICS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520478-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-538</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID LUNG</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>15 MG1ZXX PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>7 MG 1X PER DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>500 MG 1X PER 6 WK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520479-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097481</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICRONASE</medicinalproduct>
        <drugauthorizationnumb>17498</drugauthorizationnumb>
        <drugdosagetext>15 MG (15 MG, DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED THERAPY (BLINDED THERAPY)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMBVASTATIN (SIMVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIXINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520481-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004234629US</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COELIAC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REACTION TO DRUG EXCIPIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugauthorizationnumb>11153</drugauthorizationnumb>
        <drugindication>ROAD TRAFFIC ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugindication>ROAD TRAFFIC ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTISONE (CORTISONE)</medicinalproduct>
        <drugindication>INTERVERTEBRAL DISC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520482-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207945</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGICAL PROCEDURE REPEATED</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>20011022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</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>20031101</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>20031101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520484-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>205676</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.1532</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040926</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520487-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE465915NOV04</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARCINOID TUMOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
        <drugdosagetext>40 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF (TACTROLIMUS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS (ASCORBIC ACID/ERGOCALCIFEROL/FOLIC ACID/ICOTINAMIDE/PHA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT (MYOCPHENOLATE MOFETIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520489-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097725</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKULL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>8762</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXCARBAZEPINE (OXCARBAZEPINE)</medicinalproduct>
        <drugdosagetext>200 MG (100 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520491-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-552</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>B-CELL SMALL LYMPHOCYTIC LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>5 MG 1X PER 1 WK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT (ETANERCEPT, INJECTION)</medicinalproduct>
        <drugdosagetext>25 MG 2X 1WK, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS, PLAIN (MULTIVITAMINS, PLAIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520493-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>702370</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CD4 LYMPHOCYTES DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMEVIVE</medicinalproduct>
        <drugdosagetext>15 MG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040303</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NARCOTIC PATCH</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520495-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>196267</companynumb>
    <primarysource>
      <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>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</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>4520496-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>203897</companynumb>
    <primarysource></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>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P30073</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P30073</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVOGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520497-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000099</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520498-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000043</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA PNEUMOCOCCAL</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>20020601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P30091</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520499-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000039</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.978</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</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>20041115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520502-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097475</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <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>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520503-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097467</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE TABLET (MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520505-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097429</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECTOPIC PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH INJECTABLE CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>150 MG (150 MG, 1ST INJECTION), INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520506-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004051029</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRACHIAL PLEXUS INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE FRACTURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAPULA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKELETAL INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520507-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004074283</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040419</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520508-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004009355</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.3586</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOLERANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>1800 MG (TID), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>1800 MG (TID), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20 MG (DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM (LITHIUM) (LITHIUM)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugindication>PAIN IN JAW</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
        <drugindication>FACIAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
        <drugindication>PAIN IN JAW</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>1000 MG (BID), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FEELING COLD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (VITAMINS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520510-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004066417</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.0083</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED ACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</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>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEBORRHOEIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPERPIGMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE MITE (FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520512-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098386</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>20 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL (ERGOCALCIFEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERENOA REPENS (SERENOA REPENS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS (ASCORBIC ACID, ERGOCALCIFEROL FOLIC ACID, NICOTINAMIDE,</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520514-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000238</companynumb>
    <primarysource></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>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P30086</drugbatchnumb>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520517-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097260</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>150 MG (150 MG, FIRST INJECTION) INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19891108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19891108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>150 MG (150 MG, FIRST INJECTION) INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520518-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098639</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.3795</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORDIAZEPOXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520520-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098194</companynumb>
    <primarysource>
      <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 CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520521-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098195</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520522-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098559</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520523-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097639</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>28</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITUITARY TUMOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN (SOMATROPIN)</medicinalproduct>
        <drugauthorizationnumb>20280</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN (SOMATROPIN)</medicinalproduct>
        <drugauthorizationnumb>20280</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESMOPRESSIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520524-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097477</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520528-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0281720-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPANTHYL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030615</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRETANIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030615</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPEMIDIC ACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030615</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520529-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-04P-062-0282084-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520530-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-04P-013-0281737-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>REDUCTIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>WEIGHT DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPANTHYL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040618</drugenddate>
        <drugtreatmentduration>477</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIALIS ^LILLY^</medicinalproduct>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040618</drugenddate>
        <drugtreatmentduration>591</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORLISTAT</medicinalproduct>
        <drugindication>WEIGHT DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520533-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-04P-087-0282402-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVORANE LIQUID FOR INHALATION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520534-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-04P-087-0282408-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVORANE LIQUID FOR INHALATION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520535-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0281787-00</companynumb>
    <primarysource></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>SYNTHROID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METROPOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</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>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</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>NITROGLYCERIN</medicinalproduct>
        <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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520537-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0268430-00</companynumb>
    <primarysource></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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
        <drugtreatmentduration>114</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUCINDOLOL HYDROCHLORIDE</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>ATENOLOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520538-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-04P-087-0282405-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVORANE LIQUID FOR INHALATION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520539-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0281731-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520541-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SK-ABBOTT-04P-260-0280945-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLACID SR</medicinalproduct>
        <drugbatchnumb>06581VA</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLACID SR</medicinalproduct>
        <drugbatchnumb>06581VA</drugbatchnumb>
        <drugindication>TRACHEITIS</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMUDON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMUDON</medicinalproduct>
        <drugindication>TRACHEITIS</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROMETHORPHAN HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>5.44 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROMETHORPHAN HYDROBROMIDE</medicinalproduct>
        <drugindication>TRACHEITIS</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugdosagetext>2 TABLETS IN TOTAL</drugdosagetext>
        <drugindication>LARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugindication>TRACHEITIS</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520542-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-04P-087-0282322-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOVENTILATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVORANE LIQUID FOR INHALATION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520543-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-04P-087-0282420-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVORANE LIQUID FOR INHALATION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520544-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-04P-087-0282413-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVORANE LIQUID FOR INHALATION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520545-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP13079</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>30</patientweight>
      <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>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOKUNALIN</medicinalproduct>
        <drugdosagetext>1 MG, TID</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugdosagetext>0.3 ML</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTAL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FOOD ALLERGY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTAL</medicinalproduct>
        <drugdosagetext>2 ML</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZADITEN</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZADITEN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030416</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520547-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-04P-087-0282419-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVORANE LIQUID FOR INHALATION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520549-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-04P-087-0282315-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVORANE LIQUID FOR INHALATION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520561-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097667</companynumb>
    <primarysource></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>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520564-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098451</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, SINGLE), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040711</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520568-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097628</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.3597</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES (ANTIHYPERTENSIVES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520570-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097444</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.0083</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>150 MG (150 MG, EVERY 3 MONTHS, LAST INJECTION), INTRAMUSCULAR/APPROX 2004-APPROX 2004</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520572-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097102</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN (VALSARTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEREST (CHLORPHENAMINE MALEATE, METHAPYRILENE FUMARATE, PHENYLPROPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALCYLIC ACID (ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER (ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520574-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207935</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <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>20030202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520576-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097712</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER IN SITU</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520578-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000014</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</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>20030501</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>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520579-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097092</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROPROPOXYPHENE HYDROCHLORIDE (DEXTROPROPOXYPHENE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520580-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096799</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.0906</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLTERODINE LA (TOLTERODINE)</medicinalproduct>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>4 MG (4 MG, QD INTERVAL: EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520581-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004240772US</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98.4306</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B100 (AMINOBENZOIC ACID, BIOTIN, CHOLINE BITARTRATE, FOLIC ACID, INOSI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE MITE (FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520583-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098205</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520585-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098192</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER IN SITU</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520587-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AE2004-0072</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCINEX DM</medicinalproduct>
        <drugbatchnumb>4H5615F</drugbatchnumb>
        <drugauthorizationnumb>21620</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520589-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097619</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520592-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097599</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <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>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <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>ESTRADIOL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <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>4520594-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-07-1547</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugbatchnumb>4BBS506</drugbatchnumb>
        <drugauthorizationnumb>17559</drugauthorizationnumb>
        <drugdosagetext>AS NEEDED ORAL AER INH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERVENT INHALATION AEROSOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520596-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>140777USA</companynumb>
    <primarysource>
      <qualification>5</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>20622</drugauthorizationnumb>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520598-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>204468</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION LOCALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520599-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1063</companynumb>
    <primarysource>
      <qualification>1</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>TEMODAR</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>75 MG/M2 QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY NO DOSE FORM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520601-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210332</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>340 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET (ACETAMINOPHEN, BUTALBITAL, CAFFEINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520603-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-US2004-07982</companynumb>
    <primarysource>
      <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>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</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>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN (LFUCONAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESKALITH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN (WARFARIN SODIM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520604-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>235742K04USA</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL 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>20040611</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520605-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12196BP</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>20636</drugauthorizationnumb>
        <drugdosagetext>(200 MG), PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040309</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520607-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210737</companynumb>
    <primarysource>
      <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>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>385 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520609-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SP00374</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLAZAL</medicinalproduct>
        <drugauthorizationnumb>20610</drugauthorizationnumb>
        <drugdosagetext>2.25G/TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520610-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_25181_2004</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.4212</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugbatchnumb>NEW PRESCRIPT.</drugbatchnumb>
        <drugauthorizationnumb>18998</drugauthorizationnumb>
        <drugdosagetext>20 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugdosagetext>20 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520612-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>20830</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENERVATION ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
        <drugdosagetext>1000 MG QHS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520613-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1457</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>600 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFERGEN</medicinalproduct>
        <drugdosagetext>15 MCG QD SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520615-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097247</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>20.4119</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugauthorizationnumb>5845</drugauthorizationnumb>
        <drugdosagetext>30-35 TABS OR 2 BOTTLES OF LIQUID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520617-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040812</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-06720BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugdosagetext>18 MCG, IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520618-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12184BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugdosagetext>40 MG/80 MG , PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETIC NEPHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLESTIPOL (COLESTIPOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGULAR INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE NASAL SPRAY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C (ASCORBIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER (CENTRUM SILVER)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520621-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004IM000961</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48.5349</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFERGEN</medicinalproduct>
        <drugdosagetext>9 UG; QD</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520623-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>209486</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>139.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA PRIMARY ATYPICAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHONCHI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB (RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugbatchnumb>B0055</drugbatchnumb>
        <drugdosagetext>1000 MG, DAYS 1 +15, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB (RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugbatchnumb>B0055</drugbatchnumb>
        <drugdosagetext>1000 MG, DAYS 1 +15, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>100 MG , DAYS 1 + 15, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN ES (HYDROCODONE BITARTRATE,  ACETAMINOPHEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCENT-N 100 (ACETAMINOPHEN, PROPOXYPHENE  NAPSYLATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID (FOLIC ACID0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGEN (ESTROGEN NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX (VITAMIN B COMPLEX )</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE (DIPHENHYDRAMINE NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520625-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>15442</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.2762</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>50731</drugauthorizationnumb>
        <drugdosagetext>45MG/M2</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520627-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413453BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>9313Y</drugbatchnumb>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIGH BLOOD PRESSURE PILLS (NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NERVE PILL (NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520628-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415499BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.5234</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19921001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19921001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520630-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415689BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>289864F</drugbatchnumb>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>220 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520632-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415735BCC</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.1637</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>279653P</drugbatchnumb>
        <drugdosagetext>PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520633-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>206739</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB (BEVACIZUMAB) PWDR + SOLVENT, INFUSION SOLN, 100MG</medicinalproduct>
        <drugdosagetext>5MG/KG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATIN)</medicinalproduct>
        <drugdosagetext>85 MG/M2, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>500 MG/M2, 1/WEEK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>20 MG/M2, 1/WEEK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL (AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KCL (POTASSIUM CHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN (CLINDAMYCIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520635-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12380BP</companynumb>
    <primarysource></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>ATROVENT</medicinalproduct>
        <drugauthorizationnumb>19085</drugauthorizationnumb>
        <drugdosagetext>(18 MCG), IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT CONGESTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520636-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>K200401822</companynumb>
    <primarysource>
      <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>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugauthorizationnumb>21301</drugauthorizationnumb>
        <drugdosagetext>100 MCG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520637-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2004A01489</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN 9ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR 9ATORVASTATIN0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINDINE (QUINDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL (TOLTERADINE L-TARTRATE0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>(MULTIVITAMINS0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON (IRON0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIVA (MOEXIPRIL HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520639-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2004A01476</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520640-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA04065</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>2329</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITOROL-R</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRSOGLADINE MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHIMAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCYRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN-S</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520641-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0412GBR00008</companynumb>
    <primarysource>
      <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>GUILLAIN-BARRE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520643-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00214</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>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520644-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2004A01479</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.4514</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>45MG, 1 IN 1 D, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520645-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0412GBR00039</companynumb>
    <primarysource>
      <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>MYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520646-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03672</companynumb>
    <primarysource>
      <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>BILIRUBIN CONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520647-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00626</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520649-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0411GBR00272</companynumb>
    <primarysource>
      <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>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520650-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-MERCK-0412NZL00001</companynumb>
    <primarysource>
      <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>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAT RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </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>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STUDY DRUG (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STUDY DRUG (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520651-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2004A01260</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.4723</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>30 MG, 1 IN 1 D, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSULIN RESISTANCE SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS (INSULIN GLARGINE )(INJECTION)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HCTZ (HYDROCHLOROTHIAZIDE) (25 MILLIGRAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN (LOVASTATIN) (40 MILLIGRMA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520652-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2004A01170</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER IN SITU</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>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN (METHFORMIN) (500 MILLIGRAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL (GLIPIZIDE) (10 MILLIGRAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL (LISINOPRIL) (40 MILLIGRAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR (LOSARTAN POTASSIUM ) (20 MILLIGRAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) (25 MILLIGRAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C(ASCORBIC ACID) (1000 MILLIGRMA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D(CALCIUM WITH VITAMIN D) (500 MILLIGRAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E (TOCOPHEROL) (1000 MILIGRAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520655-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12196BP</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>20636</drugauthorizationnumb>
        <drugdosagetext>(200 MG), PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040309</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520657-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-06268-01</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNISOM SLEEP AID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO-DOZ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520658-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-MERCK-0411POL00012</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUSOPT</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520659-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0412GBR00014</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19901213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020311</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520660-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00495</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL ORALET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520661-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-05897-01</companynumb>
    <primarysource>
      <qualification>1</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>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC 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>20030821</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520662-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00521</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000425</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520664-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040309</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0403FRA00039</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520665-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0412GBR00009</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>25</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520666-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-05020</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYTROL</medicinalproduct>
        <drugauthorizationnumb>21351</drugauthorizationnumb>
        <drugdosagetext>1 PATCH, 2/WEEK, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELAFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN ^NOVARTIS^ (VALSARTAN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520667-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA02757</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALCOHOL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520668-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00734</companynumb>
    <primarysource>
      <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>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520669-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0412GBR00010</companynumb>
    <primarysource>
      <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>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LERCANIDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520670-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00037</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520671-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA03914</companynumb>
    <primarysource>
      <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>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDANTOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN-S</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520672-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00764</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMAUROSIS FUGAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN NEOPLASM OF EYELID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOLIPIN ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL VERTEBRA INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LEVEL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROIDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520673-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00515</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEMINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520674-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00792</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN INTRACRANIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOLYMPHATIC HYDROPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-CARDIAC CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520675-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004US002285</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
        <drugauthorizationnumb>21372</drugauthorizationnumb>
        <drugdosagetext>0.25 MG, SINGLE, IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520676-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00888</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIA URINE IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST WALL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEEDING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTED SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION PSEUDOMONAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFADROXIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520677-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415745BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BAYER NIGHT TIME</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BAYER NIGHT TIME</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520678-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0401USA01976</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>105</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APRAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSPASM CORONARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXERCISE TOLERANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE ALLERGIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC DISC DRUSEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>READING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020205</drugenddate>
        <drugtreatmentduration>97</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020205</drugenddate>
        <drugtreatmentduration>97</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND OXYCODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520679-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-DE-05902GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD HIV RNA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL MUTATION IDENTIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE (NEVIRAPINE)</medicinalproduct>
        <drugauthorizationnumb>20636</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520680-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00939</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>133</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLAUSTROPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED GASTRIC EMPTYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOMATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTOIDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEASONAL ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRABISMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS SUPERFICIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520681-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MESA 2004-019</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugauthorizationnumb>20049</drugauthorizationnumb>
        <drugdosagetext>4 G PROGRESSIVELY DECREASED AND DISCONTINUED, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520682-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9359</companynumb>
    <primarysource></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>LOCALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL (BATCH #:  P016854)</medicinalproduct>
        <drugauthorizationnumb>76131</drugauthorizationnumb>
        <drugdosagetext>270 MG, IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520683-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9358</companynumb>
    <primarysource></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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL (BATCH # P016854)</medicinalproduct>
        <drugauthorizationnumb>76131</drugauthorizationnumb>
        <drugdosagetext>270 MG, IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520684-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-13002BP</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugauthorizationnumb>20938</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL (PERINDOPRIL)</medicinalproduct>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>TRANSIENT ISCHAEMIC ATTACK</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520685-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0410GBR00130</companynumb>
    <primarysource>
      <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>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
        <drugtreatmentduration>66</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE MALEATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520686-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00418</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520687-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>105445ISR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>89519</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SIGNET-RING CELL CARCINOMA</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520688-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040909</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0409USA00689</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERMITTENT CLAUDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520689-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0411CAN00021</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520690-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>105473ISR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>89519</drugauthorizationnumb>
        <drugdosagetext>3200 MILLIGRAM, INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040925</drugenddate>
        <drugtreatmentduration>209</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX (CETUXIMAB)</medicinalproduct>
        <drugdosagetext>600 MILLIGRAM, INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
        <drugtreatmentduration>109</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>160 MILLIGRAM, INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040925</drugenddate>
        <drugtreatmentduration>157</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM FOLINATE</medicinalproduct>
        <drugdosagetext>650 MILLIGRAM, INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
        <drugtreatmentduration>207</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520691-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00246</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>198</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>198</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOLSIDOMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520692-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0410USA00518</companynumb>
    <primarysource>
      <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>CHOROIDAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIMOPTIC</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>OPEN ANGLE GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030312</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIMOPTIC</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUSOPT</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030312</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030312</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETANTOL</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030312</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAZOLAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030312</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520693-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>105486ISR</companynumb>
    <primarysource></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>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>89519</drugauthorizationnumb>
        <drugdosagetext>860 MILLGRAM, INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugdosagetext>170 MILLIGRAM, INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>860 MILLIGRAM, INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000522</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520694-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>105480ISR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>89519</drugauthorizationnumb>
        <drugdosagetext>4000 MILLIGRAM, INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>270 MILLIGRAM, INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM FOLINATE</medicinalproduct>
        <drugdosagetext>700 MILLIGRAM, INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040803</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520695-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA00250</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520696-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04240</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520697-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-535</companynumb>
    <primarysource>
      <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 EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNWANTED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>20 MG 1X PER 1 WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC (DICLOFENAC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520698-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0411CAN00017</companynumb>
    <primarysource>
      <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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520699-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA00743</companynumb>
    <primarysource>
      <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 DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520700-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03573</companynumb>
    <primarysource>
      <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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520701-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-536</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG 2X PER 1 WK, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520702-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA01647</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041128</drugenddate>
        <drugtreatmentduration>1029</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520703-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00007</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPONDYLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520704-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00173</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520705-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-593</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECHINOCOCCIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (CORTICOSTEROIDS)</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520706-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04245</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520707-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA00698</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520708-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-582</companynumb>
    <primarysource>
      <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>BLOOD BETA-D-GLUCAN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>8 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX (TEPRENONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>..</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>..</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520709-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-554</companynumb>
    <primarysource>
      <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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BETA-D-GLUCAN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>6 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>4 MG 1XD PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040403</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>6 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROM (ECABET MONOSODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFA D (ALFACLACIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST (CERVEDILOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SHIOSOL (SODIUM AUROTHIOMALATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520710-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0410GBR00304</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BASEDOW'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520711-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0412AUS00015</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520712-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00243</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520713-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-539</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>6 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040402</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3 MG/KG 1X PER 1 DAY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030923</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520714-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00250</companynumb>
    <primarysource>
      <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>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520715-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00289</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000914</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520716-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00302</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520717-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-540</companynumb>
    <primarysource>
      <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>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>6 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN-XR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520718-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00320</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHAEOCHROMOCYTOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520719-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00465</companynumb>
    <primarysource>
      <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRODIURIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520720-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03851</companynumb>
    <primarysource>
      <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030518</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520721-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00321</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520722-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-541</companynumb>
    <primarysource>
      <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>ABNORMAL CHEST SOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>6 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>8 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITROL (CALCIUM CARBONATE/ERGOCALCIFEROL/RETINOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINASTINE HYDROCHLORIDE (EPINASTINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN (LOXOPROFEN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEFENAMIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARY UNI (PIRENOXINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520723-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00315</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AXILLARY PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520724-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00036</companynumb>
    <primarysource>
      <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>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520725-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04246</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520726-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00167</companynumb>
    <primarysource>
      <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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520727-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00175</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520728-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-590</companynumb>
    <primarysource>
      <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>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>5 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugdosagetext>0.5 MG/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520729-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0412AUS00033</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520730-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00194</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520732-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-534</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>12.5 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520733-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-542</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>6 MG PER WEEK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>15 MG DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>ONE 3 MG PER/KG DOSE,  INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>ONE 3 MG PER/KG DOSE,  INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>ONE 3 MG PER/KG DOSE,  INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRAMIDE (MIANSERIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EURODIN (ESTAZOLAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHYPNOL (FLUNITRAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMICRON (GLICLAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN (LOXOPROFEN SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520734-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00024</companynumb>
    <primarysource>
      <qualification>5</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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520736-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-516</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugdosagetext>2 TABLET 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3 MG/KG/DAY, I NTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3 MG/KG/DAY, I NTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3 MG/KG/DAY, I NTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PL (CAFFEINE/PARACETAMOL/PROMETHAZINE METHYLENE DISALICYLATE/SALICYLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN (LOXOPROFEN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX (TEPRENONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCYRON (AMINOACETIC ACID/DL-METHIONINE/GLYCYRRHIZIC ACID)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520738-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0412USA00179</companynumb>
    <primarysource>
      <qualification>1</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>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MODURETIC 5-50</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOCTRAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040816</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520739-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-514</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>12.5 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3 MG/KG/DAY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3 MG/KG/DAY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3 MG/KG/DAY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER (FAMOTIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE (SODIUM GUALENATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL (ALFACALCIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520740-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00032</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520741-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-MERCK-0411SWE00058</companynumb>
    <primarysource>
      <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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOMIPRAMINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIMATOPROST</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRIMONIDINE TARTRATE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAZOLAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520742-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0412GBR00001</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPH NODE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSMEGEN</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>RHABDOMYOSARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHABDOMYOSARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHABDOMYOSARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHABDOMYOSARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHABDOMYOSARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHABDOMYOSARCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520744-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-512</companynumb>
    <primarysource>
      <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>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>5 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APOREX (DEXTROPROPOXYPHENE HYDROCHLORIDE/PARACETAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE (ZOPICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPREN-E (NAPROXEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBYL-E (ACETYLSALICYLIC ACID/MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TITRALAC (AMINOACETIC/CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITOXIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520746-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-513</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</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>5 MG PER WEEK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>6 MG PER WEEK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>6 MG PER WEEK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLETON (ZALTOPROFEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX (TEPRENONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL (ALFACALCIDOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520748-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004075229</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</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>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTIC INFILTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040819</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520760-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00462</companynumb>
    <primarysource>
      <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 PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520844-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041105810</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>4RMKA727;4RMKA713</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>4RMKA727;4RMKA713</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520845-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041106289</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>11 DOSES AT 150MG</drugdosagetext>
        <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>CO-PROXAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520846-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041106290</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520847-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20041106561</companynumb>
    <primarysource>
      <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>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>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-INFLAMMATORY AGENTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520848-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20041106606</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520849-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20041106721</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>02L067D</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>02L067D</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520850-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20041200086</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCLERAL DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCLERAL HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>4RMKA721</drugbatchnumb>
        <drugdosagetext>TOTAL OF 4 INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>4RMKA721</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>4RMKA721</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM D</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM D</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM D</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520851-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-JNJFOC-20041200095</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>4RMKA723</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>4RMKA723</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520852-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041200110</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</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>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520853-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041101667</companynumb>
    <primarysource>
      <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>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOCUTANEOUS LEISHMANIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520854-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-JNJFOC-20041102759</companynumb>
    <primarysource>
      <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>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>THE PATIENT HAS RECEIVED A TOTAL OF 17 INFUSIONS.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520855-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20040808331</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</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>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>APPROXIMATELY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>3 T</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLINORM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAZUREN S</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAZUREN S</medicinalproduct>
        <drugdosagetext>2 GRAMS</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNNORM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMATIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520856-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041004725</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABOAL SR</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOHRUS TAPE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520857-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041102014</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII 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>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugdosagetext>2 X 5 MG TABLETS PER WEEK</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>4 TABLETS</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520858-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20041008019</companynumb>
    <primarysource>
      <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>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORUDIS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520859-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041103742</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520860-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1686</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>74949</drugauthorizationnumb>
        <drugdosagetext>500-700MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520861-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-11-1659</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</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>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>74949</drugauthorizationnumb>
        <drugdosagetext>300-700MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520862-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.7924</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>ONCE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520863-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1681</companynumb>
    <primarysource>
      <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>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>74949</drugauthorizationnumb>
        <drugdosagetext>100-700 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520864-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6996</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugdosagetext>15 MLG ONCE A DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520865-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TRP_0037_2004</companynumb>
    <primarysource>
      <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>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugauthorizationnumb>76203</drugauthorizationnumb>
        <drugdosagetext>DF PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFACON-1/INTERMUNE/9MCG</medicinalproduct>
        <drugdosagetext>9 MCG QDAY SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520866-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPATIENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>300 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TREMOR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMPTERENE/HCTZ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520867-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.3273</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSINOPRIL</medicinalproduct>
        <drugdosagetext>40 MGM ONE PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520868-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIRAY 300</medicinalproduct>
        <drugbatchnumb>H291B</drugbatchnumb>
        <drugdosagetext>100 MG IV POWER INJECTOR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520869-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TRP_0036_2004</companynumb>
    <primarysource>
      <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>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugauthorizationnumb>76203</drugauthorizationnumb>
        <drugdosagetext>DF PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFACON-1 (INFERGEN)/ INTERMUNE/9 MCG</medicinalproduct>
        <drugdosagetext>9 MCG QDAY SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520870-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIRAY 300</medicinalproduct>
        <drugbatchnumb>H188H</drugbatchnumb>
        <drugdosagetext>60 ML IV HAND INJECTED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520871-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TRP_0035_2004</companynumb>
    <primarysource>
      <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>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugauthorizationnumb>76203</drugauthorizationnumb>
        <drugdosagetext>DF PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFACON-1/INTERMUNE/ 15MCG</medicinalproduct>
        <drugdosagetext>15 MCG SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520872-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.4827</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugdosagetext>ONE QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520873-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1717</companynumb>
    <primarysource>
      <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>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520874-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106.1417</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>110 MG IV Q D1, D 8</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>110 MG IV Q D1, D 8</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>110 MG IV Q D1, D 8</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>786 MG IV 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>786 MG IV 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPROT BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520875-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A        INTRON A PEN    SCHERING CORP.</medicinalproduct>
        <drugbatchnumb>4-IOL-162</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520876-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1457</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFERGEN</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>15 MCG QD SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugdosagetext>600 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520877-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE680824NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOMYCIN  (MINOCYCLINE, INJECTION)</medicinalproduct>
        <drugauthorizationnumb>50444</drugauthorizationnumb>
        <drugdosagetext>1 DOSE AT 100 MG INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020928</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METILON (METAMIZOLE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOPRAMIEL (METOCLOPRAMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUCTLACT (FRUCTOSE/POTASSIUM CHLORIDE/SODIUM CHLORIDE/SODIUM LACTATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFZON (CEFDINIR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUSCODE (CHLORPHENAMINE MALEATE/DIHYDROCODEINE PHOSPHATE/METHYLEPHEDRI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPYRINE (METAMIZOLE SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520878-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE712401DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S ADVIL</medicinalproduct>
        <drugauthorizationnumb>20589</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VARICELLA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520879-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-10-0483</companynumb>
    <primarysource>
      <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>BRONCHITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520880-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE247601DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>600MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACAMPROSATE (ACAMPROSATE)</medicinalproduct>
        <drugdosagetext>7900MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>SIX TIMES 450MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>1200MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN (METFORMIN)</medicinalproduct>
        <drugdosagetext>800MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPRID (SULPIRIDE)</medicinalproduct>
        <drugdosagetext>6400MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPICLONE (ZOPICLONE)</medicinalproduct>
        <drugdosagetext>60MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520881-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE117918OCT04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFEXOR XL (VENLAFAXINE HYDROCHLORIDE, CAPSULE, EXTENDED RELEASE, 0)</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>75 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>10 MG 1X PWER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520882-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE646823NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>18989</drugauthorizationnumb>
        <drugdosagetext>5% GEL, TWO APPLICATIONS DAILY TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>SKIN LESION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520883-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9345</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION PSEUDOMONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENOTROPHOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>8107</drugauthorizationnumb>
        <drugdosagetext>75 MG, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040725</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGAFUR URACIL</medicinalproduct>
        <drugdosagetext>400 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040725</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520884-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BEWYE246801DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETERAL NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS (SIROLIMUS, TABLET, 0)</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS (SIROLIMUS, TABLET, 0)</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS (SIROLIMUS, TABLET, 0)</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS (SIROLIMUS, TABLET, 0)</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS (SIROLIMUS, TABLET, 0)</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS (SIROLIMUS, TABLET, 0)</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520885-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0281783-00</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE  SULFATE 1MG/ML INJ. PRESERV. FRE, USP, 30ML PCA ABBOJECT (MO</medicinalproduct>
        <drugauthorizationnumb>19916</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520886-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE246601DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>2 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE (CODEINE PHOSPHATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS (TACROLIMUS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520887-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0002464</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>152</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE IMMEASURABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHYOL</medicinalproduct>
        <drugauthorizationnumb>20221</drugauthorizationnumb>
        <drugdosagetext>500 MG, 5 IN 1 WK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RADIOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHYOL</medicinalproduct>
        <drugauthorizationnumb>20221</drugauthorizationnumb>
        <drugdosagetext>500 MG, 5 IN 1 WK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RADIOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON (DEXAMETHASONE0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANZEMET (DOLASETRON MESILATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520888-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-ABBOTT-04P-118-0278434-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPILIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520889-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A03200400122</companynumb>
    <primarysource>
      <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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALFUZOSIN</medicinalproduct>
        <drugauthorizationnumb>21287</drugauthorizationnumb>
        <drugdosagetext>10 MG OD - ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520890-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>C-04-0058</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOARSENESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INITIAL INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORAL HYDRATE SYRUP, USP, 500 MG/5 ML, MGP PRODUCT CODE: 8533</medicinalproduct>
        <drugbatchnumb>25460A</drugbatchnumb>
        <drugdosagetext>2 TEASPOONS ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520891-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>003673</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugauthorizationnumb>88497</drugauthorizationnumb>
        <drugindication>EYE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugauthorizationnumb>88497</drugauthorizationnumb>
        <drugindication>RASH</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520892-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1003239</companynumb>
    <primarysource></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</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040609</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520893-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004081691</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.4514</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520894-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1003273</companynumb>
    <primarysource></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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>375MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>375 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIVALPROEX SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZTROPINE MESYLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520895-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1003480</companynumb>
    <primarysource></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>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>800MG/DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520896-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1003483</companynumb>
    <primarysource></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>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>500MG QHS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520897-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1680</companynumb>
    <primarysource>
      <qualification>3</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>74949</drugauthorizationnumb>
        <drugdosagetext>500MG, QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520898-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098331</companynumb>
    <primarysource>
      <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>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>50670</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520899-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SUSI-2004-00794</companynumb>
    <primarysource>
      <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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugauthorizationnumb>20049</drugauthorizationnumb>
        <drugdosagetext>1.5G, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
        <drugdosagetext>75 MG, DAILY</drugdosagetext>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENIOFIBRATE (FENOFIBRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL (PERINDOPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520900-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1679</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>74949</drugauthorizationnumb>
        <drugdosagetext>100-500MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520901-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-23</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520902-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SUSI-2004-00723</companynumb>
    <primarysource>
      <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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugauthorizationnumb>20049</drugauthorizationnumb>
        <drugdosagetext>4 G DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE (BUDESONIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDRONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUN CARBIMIDE (CALCIUM CARBIMIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520903-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>205193</companynumb>
    <primarysource>
      <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>CENTRAL NERVOUS SYSTEM LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</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>20040918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520904-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-33</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM (LITHIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520905-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097569</companynumb>
    <primarysource>
      <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>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRAMUSTINE PHOSPHATE SODIUM CAPSULE (ESTRAMUSTINE PHOSPHATE SODIUM)</medicinalproduct>
        <drugauthorizationnumb>18045</drugauthorizationnumb>
        <drugdosagetext>420 MG (140 MG, 3 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFUZOSIN (ALFUZOSIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM (MAGNESIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE (ESOMEPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLORAZEPATE DIPOTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE (OXYCODONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOSERELIN (GOSERELIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520906-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-29</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520907-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413212JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERCOAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARSIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520908-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004070031</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELETRIPTAN (ELETRIPTAN)</medicinalproduct>
        <drugauthorizationnumb>21016</drugauthorizationnumb>
        <drugdosagetext>ONCE (40 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE WITHOUT AURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE MALEATE</medicinalproduct>
        <drugdosagetext>25 MG (25 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSIVE SYMPTOM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520909-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097612</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXANTHEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>40 MG (20 MG, 1 IN 12 HR), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040331</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520910-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-28</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520911-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-27</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520912-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-12</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520913-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040323</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004US04357</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL VENOUS PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULAR PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN ARTERIAL PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB VS PLACEBO</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>60MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOCINONIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520914-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-09</companynumb>
    <primarysource>
      <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>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
        <drugdosagetext>50 TABLET ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520915-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugbatchnumb>P5598</drugbatchnumb>
        <drugdosagetext>10 MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugbatchnumb>P5598</drugbatchnumb>
        <drugdosagetext>10 MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS SEASONAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520916-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPRISONMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF MUTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADOLESCENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARENT-CHILD PROBLEM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABNORMAL BEHAVIOUR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520917-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XL  75 MG WYETH PHARMACEUTICALS</medicinalproduct>
        <drugdosagetext>1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520918-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugdosagetext>1 TABLET DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GINGIVAL SWELLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugdosagetext>1 TABLET DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000910</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520919-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-07</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520920-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>6,000MG  OVERDOSE ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOMANIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>6,000MG  OVERDOSE ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>6,000MG  OVERDOSE ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MANIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520921-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>1</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>1</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520922-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.5234</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugbatchnumb>16MDH</drugbatchnumb>
        <drugdosagetext>10MG X1 ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERIARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520923-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.2043</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN XR</medicinalproduct>
        <drugdosagetext>2 TAB 1/DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040315</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520924-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE647723NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugauthorizationnumb>16418</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRALYSAL (LYMECYCLINE,)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ROSACEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520925-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15843</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugdosagetext>PULSE THERAPY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPSTEIN-BARR VIRUS INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520926-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15851</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALLODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugdosagetext>140, MG/M2</drugdosagetext>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRRADIATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520927-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004US16121</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ANASTOMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POUCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>4 MG/KG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>8 MG/KG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>20 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugdosagetext>5 MG/KG, ONCE/SINGLE</drugdosagetext>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520928-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AL001602</companynumb>
    <primarysource>
      <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>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>20616</drugauthorizationnumb>
        <drugdosagetext>30 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN TRIHYDRATE</medicinalproduct>
        <drugdosagetext>3 GM; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>75 MG; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520929-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE24393NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREVILOR RETARD (VENLAFAXINE HYDROCHLORIDE, CAPSULE, EXTENDED RELEASE,</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520930-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE626922NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADHESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOALVEOLAR LAVAGE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOMYCIN (MINOCYCLINE, TABLET)</medicinalproduct>
        <drugauthorizationnumb>50649</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAVITAN (FLAVINE ADENINE DINUCLEOTIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520931-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12781621</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520932-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04410</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>200 MG ONCE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520933-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04411</companynumb>
    <primarysource>
      <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>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950912</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520934-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004PL16341</companynumb>
    <primarysource>
      <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>BRAIN STEM SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>900 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520935-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040913</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004-1803</companynumb>
    <primarysource>
      <qualification>3</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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBIDOPA AND LEVODOPA</medicinalproduct>
        <drugauthorizationnumb>73586</drugauthorizationnumb>
        <drugindication>PARKINSONIAN GAIT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DENZAPINE (CLOZAPINE)</medicinalproduct>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOVICOL (POTASSIUM CHLORIDE/SODIUM BICARBONATE/SODIUM CHLORIDE)</medicinalproduct>
        <drugdosagetext>2 SACHETS</drugdosagetext>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPICLONE (ZOPICLONE)</medicinalproduct>
        <drugdosagetext>3.75 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520936-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12782850</companynumb>
    <primarysource>
      <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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030520</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520937-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-12778510</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBELLAR ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520938-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8-99190-026A</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>4 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000604</drugenddate>
        <drugtreatmentduration>388</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SECTRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520939-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12769576</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID FACTOR POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASTEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRINIPATCH</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520940-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE691529NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOCIN (PIPERACILLIN / TAZOBACTAM, INJECTION)</medicinalproduct>
        <drugauthorizationnumb>50684</drugauthorizationnumb>
        <drugdosagetext>25 GRAM DAILY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520941-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE03721</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <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>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIAN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>UP TO 425MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520942-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03479</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGWHEEL RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASKED FACIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELLARIL</medicinalproduct>
        <drugdosagetext>25 DROPS/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugdosagetext>7.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METEOSPASMYL</medicinalproduct>
        <drugdosagetext>2 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520943-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2004AU01696</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520944-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE699429NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERNATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520945-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004-1800</companynumb>
    <primarysource>
      <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>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugauthorizationnumb>74052</drugauthorizationnumb>
        <drugdosagetext>25 MG ONCE A DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE (BENDROFLUAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICAZIDE (GLICAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520946-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NLWYE245630NOV04</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSCIOUSNESS FLUCTUATING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>150 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>40 MG 1X PER 1 DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EZETROL (EZETIMIBE, , 0)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL (PANTOPRAZOLE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORFLOXACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520947-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004-1788</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>803</patientonsetageunit>
      <patientweight>3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TALIPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>64076</drugauthorizationnumb>
        <drugdosagetext>TRANS-PLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>TRANS-PLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRUS INFLUENZA (VIRUS INFLUENZA)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRON (IRON)</medicinalproduct>
        <drugdosagetext>TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERMETHRIN</medicinalproduct>
        <drugdosagetext>TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE (BECLOMETHASONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520948-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE250001DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520949-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20041200029</companynumb>
    <primarysource>
      <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>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY BLADDER ADENOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugdosagetext>2400-3600 MG/DAY</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520950-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004GR16115</companynumb>
    <primarysource>
      <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 IRON DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugdosagetext>200 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>KERATOSIS FOLLICULAR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520951-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugbatchnumb>03314F</drugbatchnumb>
        <drugdosagetext>100-400MG   BEDTIME    ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GRAND MAL CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041127</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520952-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-06-2235</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>800 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCYCRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIZE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520953-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugdosagetext>20MG   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041128</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520954-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51.2565</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE ACCIDENTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
        <drugdosagetext>1   4-6 HRS  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>1  DAY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040625</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520955-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEU-2004-0001118</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALLADONE</medicinalproduct>
        <drugauthorizationnumb>21044</drugauthorizationnumb>
        <drugdosagetext>4 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520956-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47.6277</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE   100MG/ML   LILLY</medicinalproduct>
        <drugdosagetext>1000MG/M2   DAY 1 + 15   INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>20MG/M2      DAY 1 + 15    INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520957-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20MG  QD  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KCL TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520958-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040700474</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.65</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT RANGE OF MOTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGGER FINGER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520959-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041006058</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520960-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.3075</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>BM7400372</drugbatchnumb>
        <drugdosagetext>10MG  1 PER DAY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020417</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520961-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>100MG/M2  D18D22, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPOPHARYNGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>100MG/M2  D18D22, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAILY RADIATION OF 2.0GY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520962-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520963-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEU-2004-0001112</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMORAL NECK FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALLADONE</medicinalproduct>
        <drugauthorizationnumb>21044</drugauthorizationnumb>
        <drugdosagetext>4 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520964-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041103056</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATRECOR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATRECOR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATRECOR</medicinalproduct>
        <drugdosagetext>2 UG/KG BOLUS FOLLOWED BY 0.01MCG/KG/MINUTE INFUSION OVER A FOUR HOUR PERIOD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRO-K</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520965-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEU-2003-0001137</companynumb>
    <primarysource>
      <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>PALLADON (HYDROMORPHONE HYDROCHLORIDE) CR CAPSULE</medicinalproduct>
        <drugauthorizationnumb>21044</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520966-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0022</companynumb>
    <primarysource>
      <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>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.5 MCG/KG QW SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>1000 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520967-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1511</companynumb>
    <primarysource>
      <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>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>9 MIU QWK* SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>9 MIU QWK* SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>4 QD* ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>4 QD* ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARACYTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520968-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMMACEUTICALS, INC.-2004-BP-12063NB</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520969-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003-12-0801</companynumb>
    <primarysource>
      <qualification>1</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>HAEMATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>240MG X7DQOW* ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>240MG X7DQOW* ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>240MG X7DQOW* ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>240MG X7DQOW* ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKINE CHRONO (SODIUM VALPROATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFU-K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTHMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASDENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTECT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URBANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL (BROMAZEPAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520970-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1458</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OPTIC NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520971-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-03-1180</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>9.5</patientweight>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAVASCULAR HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFANTILE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST INTERFERENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONIC CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020610</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520972-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-0890</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPREX</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>40000 U QW SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugdosagetext>75 MG/M^2/DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENITOINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>...</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIOBLASTOMA MULTIFORME</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520973-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-143-0282076-00</companynumb>
    <primarysource>
      <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>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>19917</drugauthorizationnumb>
        <drugdosagetext>2 MG, SINGLE DOSE, INTRAVENOUS VIA PCA  SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POST PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>19917</drugauthorizationnumb>
        <drugdosagetext>2 MG, SINGLE DOSE, INTRAVENOUS VIA PCA  SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POST PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMIFENTANIL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSTIGMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCOPYRRONIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFRADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISATRACURIUM BESILATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOROLAC TROMETHAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLOCAINE W/ EPINEPHRINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520974-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004-1804</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE MALEATE</medicinalproduct>
        <drugauthorizationnumb>75887</drugauthorizationnumb>
        <drugdosagetext>100 MG DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520975-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-122807-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugauthorizationnumb>18776</drugauthorizationnumb>
        <drugdosagetext>4 MG ONCE INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000526</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>120 MG ONCE INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000526</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1 MG ONCE INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000526</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALFENTANIL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>0.5 MG ONCE INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000526</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520976-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-122666-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>DF VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040522</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520977-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097040</companynumb>
    <primarysource>
      <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>ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPEREOSINOPHILIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>10392</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DELTASONE</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IOPAMIDOL</medicinalproduct>
        <drugindication>SCAN WITH CONTRAST</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520978-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-122697-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMENSTRUAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>DF VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520979-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004084161</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPERAZON (CEFOPERAZONE, SULBACTAM)</medicinalproduct>
        <drugauthorizationnumb>50551</drugauthorizationnumb>
        <drugdosagetext>2 GRAM, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEICOPLANIN (TEICOPLANIN)</medicinalproduct>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VEEN D (CALCIUM CHLORIDE DIHYDRATE, GLUCOSE, POTASSIUM CHLORIDE, SODIU</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520980-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004069740</companynumb>
    <primarysource>
      <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>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NODULE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERRAMYCIN  (OPHTH SUSP) (OXYTETRACYCLINE)</medicinalproduct>
        <drugauthorizationnumb>61014</drugauthorizationnumb>
        <drugdosagetext>MORE THAN 10 YEARS AGO</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520981-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004016038</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE (SERTRALINE)</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>100 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE (SERTRALINE)</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>100 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB (CELECOXIB)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520982-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003033768</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BIPOLAR I DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM (LITHIUM)</medicinalproduct>
        <drugauthorizationnumb>16834</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN (CYANOCOBALAMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520983-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097083</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040827</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520984-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-122699-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>DF VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040228</drugenddate>
        <drugtreatmentduration>75</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520985-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9085</companynumb>
    <primarysource></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>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugauthorizationnumb>8107</drugauthorizationnumb>
        <drugdosagetext>75 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugdosagetext>226 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGAFUR URACIL</medicinalproduct>
        <drugdosagetext>500 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520986-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8483</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO PERITONEUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugauthorizationnumb>8107</drugauthorizationnumb>
        <drugdosagetext>120 MG PER_CYCLE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>470 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>50 MG PER_CYCLE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010522</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520987-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200412219JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORCAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORCAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLAKAY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINORIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINORIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUER</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BREDININ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRONG NEO-MINOPHAGEN C</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040629</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520988-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040709</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200412293JP</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATYPICAL MYCOBACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIA SPUTUM IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN A INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN G INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN D DIMER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCCULT BLOOD POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>DOSE: 6MG/WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTELUC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADVERSE DRUG REACTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040707</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520989-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040820</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413132FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE MORPHOLOGY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030515</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520990-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413251JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.5</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010531</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520991-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9342</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION POTENTIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>8107</drugauthorizationnumb>
        <drugdosagetext>80 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>4400 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugdosagetext>160 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520992-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004086750</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIPRASIDONE</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>80 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520993-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004080344</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520994-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100018</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDURA XL</medicinalproduct>
        <drugauthorizationnumb>19668</drugauthorizationnumb>
        <drugdosagetext>4 MG (4 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520995-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMMACEUTICALS, INC.-2004-BP-11358NB</companynumb>
    <primarysource>
      <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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981003</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520996-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-115492-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANION GAP DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXERCISE TOLERANCE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>15 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030617</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMETIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520997-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097223</companynumb>
    <primarysource>
      <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>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ZYGOMYCOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>21266</drugauthorizationnumb>
        <drugdosagetext>200 MG (1 IN 1 D)</drugdosagetext>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520998-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-115417-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>30 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040105</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>30 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040105</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>20 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040105</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>20 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040105</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORAL HYDRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN ALFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPHANE INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REPLAVITE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SACCHARATED IRON OXIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4520999-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004090278</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>50670</drugauthorizationnumb>
        <drugdosagetext>500 MG (500 MG, 1), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LARYNGOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERRAPEPTASE (SERRAPEPTASE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE (CODEINE PHOSPHATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PL GRAN. (CAFFEINE, PARACETAMOL, PROMETHAZINE METHYLENE DISALICYLATE, </medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521000-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-122849-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>DF ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040330</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521001-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000014</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDINOUS CONTRACTURE</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>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX LIQUID</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>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521002-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004089659</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MUCOSAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>50670</drugauthorizationnumb>
        <drugdosagetext>500 MG (500 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEPRENONE (TEPRENONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN HYDROBROMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUDOSTEINE (FUDOSTEINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM (MONTELUKAST SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL XINAFOATE (SALMETEROL XINAFOATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUPLATAST TOSILATE (SUPLATAST TOSILATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUGH AND COLD PREPARATIONS (COUGH AND COLD PREPARATIONS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINASTINE HYDROCHLORIDE (EPINASTINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERBINAFINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECOBALAMIN (MECOBALAMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFENIDOL HYDROCHLORIDE (DIFENIDOL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAHISTINE HYDROCHLORIDE (BETAHISTINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521003-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP01104</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSIVE SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALSLOT</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030716</drugenddate>
        <drugtreatmentduration>27360</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL</medicinalproduct>
        <drugdosagetext>900 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUVOX</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040107</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521004-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15632</companynumb>
    <primarysource>
      <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>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
        <drugtreatmentduration>36000</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521005-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004087363</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDURA XL</medicinalproduct>
        <drugauthorizationnumb>19668</drugauthorizationnumb>
        <drugdosagetext>8 MG (8 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE (BENDROFLUMETHIAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN (TELMISARTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIM (METFORMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521006-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-122776-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>DF</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521007-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-122828-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>99</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</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>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>30 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugdosagetext>200 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>75 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDRONEL PMO ^PROCTER + GAMBLE^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GTN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEFOPAM HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSVASIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521008-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-SHR-03-017450</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE BIPHASIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE INVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAFERON (INTERFERON BETA-1B) INJECTION</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAFERON (INTERFERON BETA-1B) INJECTION</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IKTORIVIL (CLONAZEPAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521009-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-122818-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>15 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040528</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOCTRAN 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAHISTINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALIMEMAZINE TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521010-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2004-035626</companynumb>
    <primarysource>
      <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>BLOOD HUMAN CHORIONIC GONADOTROPIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030614</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521011-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2004-029973</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAFERON (INTERFERON BETA-1B)INJECTION 250 UG</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521012-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-122860-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CUTANEOUS VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>15 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>100 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>40 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENPROCOUMON</medicinalproduct>
        <drugdosagetext>DF ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>DF ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>DF ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPHANE INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN ASPART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURORUBIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521013-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16023</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLAKAY</medicinalproduct>
        <drugdosagetext>45 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CABAGIN-U</medicinalproduct>
        <drugdosagetext>6 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521014-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003-104643-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL BYPASS OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY REVASCULARISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPARIN-INDUCED THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET AGGREGATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DANAPAROID SODIUM</medicinalproduct>
        <drugauthorizationnumb>20430</drugauthorizationnumb>
        <drugdosagetext>7500 ANTI_XA/533 ANTI_XA Q1HR/1500 ANTI_XA ONCE/1500 ANTI_XA ONCE/760 ANTI_XA Q1HR INTRAVENOUS BOLUS</drugdosagetext>
        <drugindication>ANGINA UNSTABLE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DANAPAROID SODIUM</medicinalproduct>
        <drugauthorizationnumb>20430</drugauthorizationnumb>
        <drugdosagetext>7500 ANTI_XA/533 ANTI_XA Q1HR/1500 ANTI_XA ONCE/1500 ANTI_XA ONCE/760 ANTI_XA Q1HR INTRAVENOUS BOLUS</drugdosagetext>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
        <drugindication>ANGINA UNSTABLE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROTININ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521015-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2004-031469</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAFERON (INTERFERON BETA-1B) INJECTION 250 UG</medicinalproduct>
        <drugdosagetext>EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521016-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419105US</companynumb>
    <primarysource>
      <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>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC-D 12 HOUR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521017-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419142US</companynumb>
    <primarysource>
      <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOR-TRIMETON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521018-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419174US</companynumb>
    <primarysource>
      <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>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>D077</drugbatchnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGULAR ILETIN II</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: SLIDING SCALE</drugdosagetext>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521019-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419214US</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>TK16070</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROSTAT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521020-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414493FR</companynumb>
    <primarysource></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>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFATER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEPRONIZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUPHENAZINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521021-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414501FR</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN UPPER</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>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIRODOGYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DENTAL CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDETTE-21</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIALGIREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521022-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419231US</companynumb>
    <primarysource>
      <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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521023-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413566EU</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521024-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421805GDDC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERICORONITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521025-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200412726DE</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOHEXAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HCT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521026-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413581EU</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>VAGINITIS BACTERIAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031204</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521027-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414533FR</companynumb>
    <primarysource></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>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOPHLEBITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATINE</medicinalproduct>
        <drugindication>CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VEPESID</medicinalproduct>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521028-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419262US</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUBAIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521029-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200417523US</companynumb>
    <primarysource>
      <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>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>BRONCHITIS ACUTE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER RESPIRATORY SYSTEM PRODUCTS</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521030-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413718FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521031-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040825</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200416393US</companynumb>
    <primarysource>
      <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>BLOOD IRON DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>9467</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BLOOD DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PINDOLOL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLTX</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
        <drugindication>THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521032-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421524GDDC</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPARIN-INDUCED THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAHISTINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521033-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200417077US</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADHESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNIOTIC FLUID VOLUME DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 5-10-15 UNITS ; FREQUENCY: BEFORE MEALS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN LENTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521034-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200417079US</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNIOTIC FLUID VOLUME DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521035-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200418363US</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IATROGENIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN OINTMENT</medicinalproduct>
        <drugdosagetext>DOSE: 1 INCH</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KCL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521036-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030825</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200313205FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAFORAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MENINGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MENINGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MENINGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NARAMIG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACUPAN</medicinalproduct>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPALGIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030623</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521037-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200418855US</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAMPYLOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>CARDIAC OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCUVITE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521038-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-2004-033011</companynumb>
    <primarysource>
      <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>BETASERON</medicinalproduct>
        <drugbatchnumb>TA8569A</drugbatchnumb>
        <drugdosagetext>8MIU,EVERY 2D NEW AUTOINJECTOR, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040730</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521039-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE867601JUL04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELEVATED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZHEXOL  (TRIHEXYPHENIDYL TABLET, 0)</medicinalproduct>
        <drugauthorizationnumb>6773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSKINESIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZHEXOL  (TRIHEXYPHENIDYL TABLET, 0)</medicinalproduct>
        <drugauthorizationnumb>6773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSTONIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZHEXOL  (TRIHEXYPHENIDYL TABLET, 0)</medicinalproduct>
        <drugauthorizationnumb>6773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSKINESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040518</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZHEXOL  (TRIHEXYPHENIDYL TABLET, 0)</medicinalproduct>
        <drugauthorizationnumb>6773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSTONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040518</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZHEXOL  (TRIHEXYPHENIDYL TABLET, 0)</medicinalproduct>
        <drugauthorizationnumb>6773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSKINESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZHEXOL  (TRIHEXYPHENIDYL TABLET, 0)</medicinalproduct>
        <drugauthorizationnumb>6773</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSTONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031022</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521040-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>25701</companynumb>
    <primarysource></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 OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDARA</medicinalproduct>
        <drugauthorizationnumb>20723</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>CONDYLOMA ACUMINATUM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521041-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200412255FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</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>KETEK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521042-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413395EU</companynumb>
    <primarysource>
      <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>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A+D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521043-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12776563</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROVEL TABS 150 MG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STABLON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521044-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A02200402415</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STILLNOX - (ZOLPIDEM) - TABLET - 10 MG</medicinalproduct>
        <drugauthorizationnumb>19908</drugauthorizationnumb>
        <drugdosagetext>200 MG ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040715</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERCIAN - (CYAMEMAZINE) - TABLET - 25 MG</medicinalproduct>
        <drugdosagetext>1000 MG ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENTAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040715</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYSANXIA - (PRAZEPAM) - TABLET- 40 MG</medicinalproduct>
        <drugdosagetext>10400 MG ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040715</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040715</drugenddate>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFAN (PARACETAMOL/CAFFEINE/DEXTROPROPOXYPHENE)- TABLET - 457 MG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040715</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521045-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-2004-035661</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAFERON (INTERFERON BETA-1B)INJECTION 250 UG</medicinalproduct>
        <drugdosagetext>8 MIU,SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521046-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F04200400306</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXANTHEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>150 MG OTHER (CUMULATIVE DOSE: 900 MG)</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040823</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>(LEUCOVORIN) - SOLUTION</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEVATRIL (GRANISETRON HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETAHSON (DEXAMETHASONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521047-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040617</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F02200400048</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROGRADE EJACULATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XATRAL - (ALFUZOSIN) - TABLET PR - 10 MG</medicinalproduct>
        <drugauthorizationnumb>21287</drugauthorizationnumb>
        <drugdosagetext>10 MG OD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040520</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ART 50 (DIACEREIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DENTENSIEL (BISOPROLOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DHEA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521048-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ENT 2004-0171</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMTAN</medicinalproduct>
        <drugauthorizationnumb>20796</drugauthorizationnumb>
        <drugdosagetext>800 MG (200 MG, 4 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STABLON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521049-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-122734-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>DF, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040515</drugenddate>
        <drugtreatmentduration>136</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521050-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-115406-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>30 MG QD</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030614</drugenddate>
        <drugtreatmentduration>236</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAHISTINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>MC</drugdosagetext>
        <drugindication>VERTIGO</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030624</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521051-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-505</companynumb>
    <primarysource>
      <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>BRAIN SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>12.5 MG 1X PER 1WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521052-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-480</companynumb>
    <primarysource>
      <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>BLOOD CHOLESTEROL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>12.5 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521053-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE676724NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>75 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>75 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GERODORM (CINOLAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521054-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-467</companynumb>
    <primarysource>
      <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>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>4MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAMA (ACETYLSALICYLIC ACID/ALUMINIUM HYDROXIDE GEL,DRIED/MAGNESIUM HYD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORINAEL (NIFEDIPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMEDIN (BENFOTIAMINE/CYANOCOBALAMIN/PHYRIDOXINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORINAEL (NIFEDIPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE (MAGNESIUM OXIDE0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL (ALFACALCIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMEDIN(BENFOTIAMINE/CYANOCOBALAMIN/PYRIDOXINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521055-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-555</companynumb>
    <primarysource>
      <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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>7.5 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIZATIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN(LOXOPROFEN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL (ALFACALCIDOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521056-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-596</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MACROCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFRACTORY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIDEROBLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>7.5 MG 1X PER WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15MG 1X PER WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>12.5 MG 1X PER WK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (CORTICOSTROIDS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLSALAZOPYRINE (METHYLSALAZOPHRINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED NON-STEROIDAL ANTI-INFLAMMATORY AGENT(UNSPECIFIED NON-STER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521057-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE247601DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>600MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE (ZOPLICONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPRID (SULPIRIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACAMPROSATE (ACAMPROSATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521058-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-115310-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESOGESTREL AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>20713</drugauthorizationnumb>
        <drugdosagetext>DF</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521059-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-595</companynumb>
    <primarysource>
      <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>ANIMAL SCRATCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS INFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MECHANICAL COMPLICATION OF IMPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS PASTEURELLA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>15MG 1X PER WK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521060-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-594</companynumb>
    <primarysource>
      <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>CANDIDA PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUSARIUM INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DESQUAMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>1 MG/KG TWICE DAILY, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLISTIN SULFATE (COLISTIN SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521061-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-119374-NL</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>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DANAPAROID SODIUM</medicinalproduct>
        <drugauthorizationnumb>20430</drugauthorizationnumb>
        <drugdosagetext>250 ANTI_XA</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DISSEMINATED INTRAVASCULAR COAGULATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040215</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIVELESTAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEICOPLANIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN INTRAVENOUS (HUMAN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521062-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-10785</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</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>20031015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETAZIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFATE FERREUX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUINDIONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521063-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-122809-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKAEMIA PLASMACYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>15 MG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>15 MG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugdosagetext>10 MG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRALAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521064-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-116608-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DROWNING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>15 MG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040305</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPLICONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521065-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040812</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-119374-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DANAPAROID SODIUM</medicinalproduct>
        <drugauthorizationnumb>20430</drugauthorizationnumb>
        <drugdosagetext>2500 ANTI_XA</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DISSEMINATED INTRAVASCULAR COAGULATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040215</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIVELESTAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEICOPLANIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN INTRAVENOUS (HUMAN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521066-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-10739</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>35 MG QWK IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICANORM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XUSAL (LEVOCETIRIZIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521067-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE241530NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN INTRACRANIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCIN</medicinalproduct>
        <drugauthorizationnumb>50649</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521068-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE693629NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>200 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE (AMIODARONE, INJECTION)</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521069-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE641523NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>200 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
        <drugdosagetext>250 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL (ENALAPRIL,)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYLORIC (ALLOPURINOL,)</medicinalproduct>
        <drugdosagetext>100 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDREA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521070-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-10830</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</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>20031015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETAZIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFATE FERREUX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUINDIONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521071-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RENA-11213</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC OUTLET OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</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>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE GEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521072-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NLWYE245730NOV04</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>75 MG 1X PER 1 DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX (CLOZAPINE, , 0)</medicinalproduct>
        <drugdosagetext>50 MG 3X PER 1 DAY</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOZINAN (LEVOMEPROMAZINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521073-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CERZ-10676</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAUCHER'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>20367</drugauthorizationnumb>
        <drugdosagetext>2800 UNITS Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521074-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE490717NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugauthorizationnumb>50649</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugdosagetext>200 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONALON (ALENDRONATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521075-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE265605NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBOTHROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>3 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFIBRATE (CIPROFIBRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521076-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE694029NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALESSE</medicinalproduct>
        <drugauthorizationnumb>20683</drugauthorizationnumb>
        <drugdosagetext>1 TABLET 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521077-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AC00779</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPIVACAINE</medicinalproduct>
        <drugauthorizationnumb>71202</drugauthorizationnumb>
        <drugdosagetext>15 MG ONCE</drugdosagetext>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>GIVEN IN ERROR</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>25 [MU] G</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521078-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE254024NOV03</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADENOCARCINOMA OF THE CERVIX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO UTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>50738</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>50738</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521079-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE06597</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugauthorizationnumb>20441</drugauthorizationnumb>
        <drugdosagetext>100 MCG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521080-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05931</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OCULAR NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugauthorizationnumb>20441</drugauthorizationnumb>
        <drugdosagetext>12 PUFF DAILY IH</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521081-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE680624NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTIUM (PANTOPRAZOLE, TABLET, DELAYED RELEASE)</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
        <drugdosagetext>40 MG 2X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521082-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210609</companynumb>
    <primarysource>
      <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>ALCOHOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TENDERNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>950 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>47.5 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>475 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521083-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>209933</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPIRATION BONE MARROW ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL TOXIC GRANULATION PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>700 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INEXIUM (ESOMEPRAZOLE MAGNESIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL (TRIMETAZIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLIPRANE (ACETAMINOPHEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIABLSTINE (DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521084-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>209527</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>700 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINE NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521085-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004092043</companynumb>
    <primarysource>
      <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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (1 IN 1 D); ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZOSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILNIDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOGLIBOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZBROMARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521086-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096029</companynumb>
    <primarysource>
      <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 SYSTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugauthorizationnumb>19835</drugauthorizationnumb>
        <drugdosagetext>20 MG; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521087-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004087548</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521088-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200411131BVD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521089-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200418373US</companynumb>
    <primarysource>
      <qualification>2</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 HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE EXACERBATED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugindication>SEPSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugindication>CLOSTRIDIUM COLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521090-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410626BYL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521091-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2004AU01663</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.0151</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISUDYNE</medicinalproduct>
        <drugauthorizationnumb>21119</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521092-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE03901</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL EXUDATES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISUDYNE</medicinalproduct>
        <drugauthorizationnumb>21119</drugauthorizationnumb>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030916</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521093-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SUSI-2004-00789</companynumb>
    <primarysource>
      <qualification>3</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugauthorizationnumb>20049</drugauthorizationnumb>
        <drugdosagetext>500 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>750 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAFLON (DIOSMIN)</medicinalproduct>
        <drugdosagetext>2 TABLETS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugdosagetext>30 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KARDEGIC/SCH/(LYSINE ASPIRIN)</medicinalproduct>
        <drugdosagetext>160 MG, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STILNOX/SCH/(ZOLPIDEM TARTRATE)</medicinalproduct>
        <drugdosagetext>1 TABLET/DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XATRAL LP</medicinalproduct>
        <drugdosagetext>5 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521094-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004VX000915</companynumb>
    <primarysource></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>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>12209</drugauthorizationnumb>
        <drugdosagetext>950 MG; INTRAVENOUS; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE (CALCIUM LEVOFOLINATE)</medicinalproduct>
        <drugdosagetext>400 MG; INTRAVENOUS; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040922</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521095-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004VX000916</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>12209</drugauthorizationnumb>
        <drugdosagetext>2000 MG; INTRA-ARTERIAL</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT RECURRENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>INTRA-ARTERIAL</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT RECURRENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521096-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004IM000933</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE STOOLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAFERON (A643_INTERFERON ALFACON_1)</medicinalproduct>
        <drugdosagetext>18 MU;QD; SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521097-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2004A04381</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>30 MG (30 MG, 1 D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>92</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521098-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPG2004A00312</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040721</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521099-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2004A00853</companynumb>
    <primarysource></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>DEFAECATION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC SEIZURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTION SICKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>15 MG (15 MG, IN THE MORNING)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040512</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521100-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2004A02036</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030805</drugenddate>
        <drugtreatmentduration>750</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031111</drugenddate>
        <drugtreatmentduration>88</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBUCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACARBOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521101-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003-BP-06939NB</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugauthorizationnumb>20938</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030325</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTZ (HYALURONATE SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521102-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE227123NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIPSYCHOTIC DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM REPOLARISATION ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTOLIC HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>50 MG 3X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>50 MG 3X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERTRALINE (LITHIUM CARBONATE,, 0)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR II DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERTRALINE (LITHIUM CARBONATE,, 0)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR II DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE (ZOPICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521103-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GRWYE228524NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>150 MG 2X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>10 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521104-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE695229NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521105-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-NOVOPROD-240711</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IATROGENIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTUBATION COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>300 UG/KG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UPPER GASTROINTESTINAL HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>1200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDOSTATIN</medicinalproduct>
        <drugdosagetext>50 UNK, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDOSTATIN</medicinalproduct>
        <drugdosagetext>1.2 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OFLOCET</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>3 G, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521106-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004-1802</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGLE CLOSURE GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE UNK, UNKNOWN MANUFACTURER</medicinalproduct>
        <drugauthorizationnumb>75887</drugauthorizationnumb>
        <drugdosagetext>50MG DAILY</drugdosagetext>
        <drugindication>TENSION HEADACHE</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521107-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12192BP</companynumb>
    <primarysource></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>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
        <drugtreatmentduration>837</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
        <drugtreatmentduration>837</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
        <drugtreatmentduration>826</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
        <drugtreatmentduration>826</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETALOC (METOPROLOL TARTRATE) (NR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASA (ACETYLSALICYLIC ACID) (NR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC (NR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRATES (NR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN (NR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B1, 6 + 12 (NR)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521108-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12191BP</companynumb>
    <primarysource></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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETALOC (METOPROLOL TARTRATE) (NR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASA (ACETYLSALICYLIC ACID) (NR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC (NR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRATES (NR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATINS (NR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B, 6 +12 (NR)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521109-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE223122NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>18989</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEGRIVAC (INFLUENZA VIRUS VACCINE POLYVALENT, INJECTION, 0)</medicinalproduct>
        <drugdosagetext>SC; VACCINATE DATE:</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM (TIMETHRORIM,  , 0)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTIVE NOS (ORAL CONTRACEPTIVE NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521110-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004-1801</companynumb>
    <primarysource>
      <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>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC UNK, UNKNOWN MANUFACTURER</medicinalproduct>
        <drugauthorizationnumb>74376</drugauthorizationnumb>
        <drugdosagetext>50MG TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMPAZEPAM, UNK, UNKNOWN MANUFACTURER</medicinalproduct>
        <drugdosagetext>10 MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CO-CODAMOL (CODEINE/PARACETAMOL)</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugdosagetext>180MG/ 12 HOURS AND 2 DOSES OF 360MG</drugdosagetext>
        <drugindication>ASPERGILLOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOTHIEPIN (DOTHIEPIN)</medicinalproduct>
        <drugdosagetext>100MG QHS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521111-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_25442_2004</companynumb>
    <primarysource></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>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATIONS, MIXED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
        <drugauthorizationnumb>17794</drugauthorizationnumb>
        <drugdosagetext>DF PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
        <drugdosagetext>DF PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521112-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>105477ISR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>89519</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-DYDRAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521113-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20010410</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-ROCHE-258377</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010315</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010315</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001112</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010401</drugenddate>
        <drugtreatmentduration>140</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010601</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001112</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001227</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010330</drugenddate>
        <drugtreatmentduration>93</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521114-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-384165</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>38</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROVALCYTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROVALCYTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>IMUREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>187</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMEVAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CYTOMEGALOVIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>REPORTED AS 3 DAYS PER WEEK.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>125</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOIDS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040228</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521115-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-386354</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EDUCATIONAL PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOAFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021215</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521116-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-384323</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTANE</medicinalproduct>
        <drugdosagetext>DOSAGE OF 50 MG PER MONTH.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521117-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-388051</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CELLULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040727</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOXACILLIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CELLULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040727</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521118-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-387671</companynumb>
    <primarysource>
      <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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040622</drugenddate>
        <drugtreatmentduration>121</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANABOLIC STEROIDS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521119-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>105485ISR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>89519</drugauthorizationnumb>
        <drugdosagetext>880 MILLIGRAM INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000906</drugenddate>
        <drugtreatmentduration>114</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>880 MILLIGRAM INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000906</drugenddate>
        <drugtreatmentduration>114</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugdosagetext>175 MILLIGRAM INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000906</drugenddate>
        <drugtreatmentduration>114</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521120-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-387853</companynumb>
    <primarysource>
      <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>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHARMORUBICIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521121-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-386256</companynumb>
    <primarysource>
      <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>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEGATIVE THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LARIAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521122-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040920</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ROCHE-380769</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTI-PLATELET ANTIBODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
        <drugtreatmentduration>130</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>TRADE NAME: PROPRANOLOLKLORID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010515</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521123-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-387527</companynumb>
    <primarysource>
      <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>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VEIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
        <drugtreatmentduration>94</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>UNKNOWN UNITS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNKNOWN UNITS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEBUTOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM / SULFAMETOXAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521124-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-387722</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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOSENTAN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-K</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521125-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ROCHE-387698</companynumb>
    <primarysource>
      <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>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORADIUR</medicinalproduct>
        <drugdosagetext>PATIENT RECEIVED TORASEMIDE ONCE DAILY, FOR FOUR TO FIVE DAYS PER MONTH, DURING HER MENSTRUAL CYCLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>367</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMINULET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521126-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-387908</companynumb>
    <primarysource>
      <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>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521127-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-387925</companynumb>
    <primarysource>
      <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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521128-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-388050</companynumb>
    <primarysource>
      <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>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521129-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ROCHE-388054</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CAVITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM + SULFAMETHOXAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521130-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-387939</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugdosagetext>FORMULATION REPORTED AS: INJECTABLE SOLUTION.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PYELONEPHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521131-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-388060</companynumb>
    <primarysource>
      <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>BONDRONAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521132-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ROCHE-388073</companynumb>
    <primarysource>
      <qualification>1</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>XENICAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521133-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ROCHE-388071</companynumb>
    <primarysource>
      <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>LYMPHOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521134-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-CN-00434CN</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>ATROVENT</medicinalproduct>
        <drugauthorizationnumb>19085</drugauthorizationnumb>
        <drugdosagetext>(20 MCG) IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521135-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-CN-00433CN</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>ATROVENT</medicinalproduct>
        <drugauthorizationnumb>19085</drugauthorizationnumb>
        <drugdosagetext>(20 MCG) IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521136-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-09225BR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugdosagetext> 80 MG, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>0.25 MG (0.25 MG), PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040903</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521137-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210758</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN (TRASTUZUMAB) PWDR + SOLVENT, INFUSION SOLN, 440MG</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN (TRASTUZUMAB) PWDR + SOLVENT, INFUSION SOLN, 440MG</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN (TRASTUZUMAB) PWDR + SOLVENT, INFUSION SOLN, 440MG</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN (TRASTUZUMAB) PWDR + SOLVENT, INFUSION SOLN, 440MG</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>960 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>960 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>62.5 MG, Q4W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>62.5 MG, Q4W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUORORACL (FLUOROURACIL)</medicinalproduct>
        <drugdosagetext>950 MG, Q4W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUORORACL (FLUOROURACIL)</medicinalproduct>
        <drugdosagetext>950 MG, Q4W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521138-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>205549</companynumb>
    <primarysource></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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040903</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL (DOCETAXEL)</medicinalproduct>
        <drugdosagetext>150 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITAL (RANITIDINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521139-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210741</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>8 MG/KG, SINGLE; INTRAVENOUS (SEE IMAGE)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521140-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00728</companynumb>
    <primarysource>
      <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>
      <reaction>
        <reactionmeddrapt>ASEPTIC NECROSIS BONE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIHYDRALAZINE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METILDIGOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521141-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>K200401817</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEPTRA</medicinalproduct>
        <drugauthorizationnumb>17376</drugauthorizationnumb>
        <drugdosagetext>3 TIMES/WEEK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE (METHADONE)90 MG</medicinalproduct>
        <drugdosagetext>90 MG, QD; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDINAVIR (INDINAVIR) 600</medicinalproduct>
        <drugdosagetext>600 UNK, UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521142-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004-1798</companynumb>
    <primarysource>
      <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>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugauthorizationnumb>70663</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRALYSAL, UNK, UNKNOWN MANUFACTURER</medicinalproduct>
        <drugdosagetext>1 OD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ROSACEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521143-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00697</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521144-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00537</companynumb>
    <primarysource>
      <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>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521145-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-MERCK-0412CHN00006</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BILIRUBIN CONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521146-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210740</companynumb>
    <primarysource>
      <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>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521147-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004086396</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>40 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugdosagetext>150 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE (ESOMEPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HYDROCHLORIDE (DOXYCYCLINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUSIDATE SODIUM (FUSIDATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521148-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413089GDS</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>112</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugauthorizationnumb>20198</drugauthorizationnumb>
        <drugdosagetext>10 MG, BID; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521149-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097068</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED IMMUNE RESPONSIVENESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>NEUROPATHIC PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THERAPEUTIC RADIOPHARMACEUTICALS (THERAPEUTIC RADIOPHARMACEUTICALS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA (SENNA)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521150-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12757993</companynumb>
    <primarysource>
      <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>COLON CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010620</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIACIN</medicinalproduct>
        <drugdosagetext>START DATE:  MAR-2001.  DURATION: 4 CYCLES</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010531</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugdosagetext>START DATE:   MAR-2001.  DURATION:  4 CYCLES</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010531</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>START DATE:  MAR-2001.  DURATION:  4 CYCLES</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010531</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010804</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERIPHERAL BLOOD STEM CELL TRANSPLANTATION</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010806</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521151-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA02333</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVOUSNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED) AND VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521152-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00696</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLEPHARITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIDEPRESSANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521153-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200411130BVD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521154-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098594</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521155-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0311USA02526</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
        <drugtreatmentduration>336</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL MSD LP</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIBACTERIAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIBACTERIAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIBACTERIAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011110</drugenddate>
        <drugtreatmentduration>284</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011110</drugenddate>
        <drugtreatmentduration>284</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETRIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIBACTERIAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MOTION SICKNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANALGESIC EFFECT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521156-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0412GBR00043</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND CODEINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521157-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0304USA00825</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABILE HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRACHEAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521158-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-MERCK-0411POL00009</companynumb>
    <primarysource>
      <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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>198</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>1328</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>198</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521159-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA02737</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521160-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00672</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>BRAIN STEM INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
        <drugtreatmentduration>825</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAFRONYL OXALATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE AND METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENPROCOUMON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIHYDRALAZINE SULFATE AND HYDROCHLOROTHIAZIDE AND RESERPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521161-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099232</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FELDENE</medicinalproduct>
        <drugauthorizationnumb>18147</drugauthorizationnumb>
        <drugdosagetext>(20 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETORICOXIB (ETORICOXIB)</medicinalproduct>
        <drugdosagetext>60 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIOCOLCHICOSIDE (THIOCOLCHICOSIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521162-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-MERCK-0410NZL00033</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521163-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0302USA00112</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>114</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHONDROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC LYMPHOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE INVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALLORY-WEISS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHONCHI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MONARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND PROPOXYPHENE NAPSYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARISOPRODOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND CODEINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000225</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521164-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12060BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030326</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030326</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030326</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISORDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPENT (ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX (B-KIMPLEX ^LECIVA^)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521165-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099642</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>8762</drugauthorizationnumb>
        <drugdosagetext>300 MG (300 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521166-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP03577</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELAYED RECOVERY FROM ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO PAIN STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>19627</drugauthorizationnumb>
        <drugdosagetext>MAX. DOSE 12 ML/HR. AVERAGE DOSE 8-10 ML/HR</drugdosagetext>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANEST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBENIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELASPOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATABON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAZUCROSS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521167-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-BRISTOL-MYERS SQUIBB COMPANY-12782413</companynumb>
    <primarysource>
      <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>VENOUS THROMBOSIS LIMB</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ TABS 600 MG</medicinalproduct>
        <drugdosagetext>ONCE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX EC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAONIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521168-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12727863</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>136</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>10CC'S.  PRESCRIBED DOSE WAS 960 MG.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMETIDINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521169-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004090318</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20882</drugauthorizationnumb>
        <drugdosagetext>2400 MG (800 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RADICULOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFAN (CAFFEINE, CARBASALATE CALCIUM, CHLORPHENAMINE MALEATE, DEXTR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PINAVERIUM BROMIDE (PINAVERIUM BROMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521170-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA02615</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PLANTAR FASCIITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19730701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SWELLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830624</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830624</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521171-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00533</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA SUPRAVENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INNER EAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040810</drugenddate>
        <drugtreatmentduration>420</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040810</drugenddate>
        <drugtreatmentduration>420</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
        <drugtreatmentduration>1533</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
        <drugtreatmentduration>2171</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521172-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02335</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>20541</drugauthorizationnumb>
        <drugdosagetext>1 MG QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLORADIX KRAUTERBLUT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>..</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521173-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004240557JP</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>20571</drugauthorizationnumb>
        <drugdosagetext>146 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOMETRIAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOMYCIN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOMETRIAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040819</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521174-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004PK02017</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROPOFOL INFUSION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugauthorizationnumb>19627</drugauthorizationnumb>
        <drugdosagetext>5.75 MG/KG CONT; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STATUS EPILEPTICUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521175-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12783361</companynumb>
    <primarysource>
      <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>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL VARICES HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOOCCLUSIVE LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>REC'D 250 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040824</drugenddate>
        <drugtreatmentduration>162</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPTOSAR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040824</drugenddate>
        <drugtreatmentduration>162</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040102</drugenddate>
        <drugtreatmentduration>963</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521176-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00001</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC MYXOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE AND CHOLECALCIFEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030214</drugenddate>
        <drugtreatmentduration>799</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521177-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00796</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>114</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARTILAGE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICOBRACHIAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS EROSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIMPLE PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOLILOQUY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521178-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03709</companynumb>
    <primarysource>
      <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>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521179-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04096</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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOTAL LUNG CAPACITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYPROHEPTADINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLOFENAMATE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521180-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098571</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXANTHEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>50670</drugauthorizationnumb>
        <drugdosagetext>500 MG (250 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>50670</drugauthorizationnumb>
        <drugdosagetext>500 MG (250 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGOLARYNGEAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521181-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03145</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>1768</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521182-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004009791</companynumb>
    <primarysource>
      <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>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>10392</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>75 MG (1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIOTHYRONINE SODIUM</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM POSTOPERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL (ACENOCOUMAROL)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521183-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-MERCK-0411AUT00022</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521184-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00888</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521185-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04144</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521186-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00817</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADJUSTMENT DISORDER WITH ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLAT AFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERNICIOUS ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGGER FINGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS DETACHMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REPETITIVE STRAIN INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BURSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000703</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521187-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12202RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugauthorizationnumb>6134</drugauthorizationnumb>
        <drugdosagetext>180 MG , PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG WITHDRAWAL MAINTENANCE THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORPROTHIXENE (CHLORPROTHIXENE)</medicinalproduct>
        <drugdosagetext>15 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ (EFAVIRENZ)</medicinalproduct>
        <drugdosagetext>600 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIANSERINE</medicinalproduct>
        <drugdosagetext>30 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugdosagetext>264 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNITRAZEPAM (FLUNITRAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPINAVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521188-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05859</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>250 MG DAILY; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521189-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP06033</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020619</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521190-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12201RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugauthorizationnumb>6134</drugauthorizationnumb>
        <drugdosagetext>230 MG, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE (SERTRALINE)</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLORAZEPATE (CLORAZEPATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM (MAGNESIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521191-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02337</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>250 MG DAILY; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFENE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOTHIEPIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL/FLUTICASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERBUTALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO MATCH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521192-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0311USA02552</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUBITAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT AND COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE STOOLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISTARIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030314</drugenddate>
        <drugtreatmentduration>1039</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010524</drugenddate>
        <drugtreatmentduration>409</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020325</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000510</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521193-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-MERCK-0410CHN00033</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHORIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040805</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040816</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>POST PROCEDURAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND PROPOXYPHENE NAPSYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED SAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040729</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040806</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040805</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
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      <senderorganization>FDA-Public Use</senderorganization>
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        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
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        <drugindication>HIV INFECTION</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020812</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020328</drugstartdate>
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        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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        <drugstartdate>20020812</drugstartdate>
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        <medicinalproduct>VIREAD</medicinalproduct>
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        <drugstartdate>20040903</drugstartdate>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTRIVA</medicinalproduct>
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        <drugstartdate>20040903</drugstartdate>
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  <safetyreport>
    <safetyreportid>4521195-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedateformat>102</receivedateformat>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
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      <drug>
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    <safetyreportid>4521196-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
      <patientonsetage>35</patientonsetage>
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      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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    <safetyreportid>4521197-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
      <patientonsetage>78</patientonsetage>
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      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC DECREASED</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>COAGULATION TIME PROLONGED</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-ABDOMINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL SITE REACTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>3 MG DAILY; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041030</drugstartdate>
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        <drugenddate>20041114</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>1.5 MG DAILY; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
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        <drugenddate>20041121</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIO THREE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANATON</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCELASE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
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  <safetyreport>
    <safetyreportid>4521198-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedateformat>102</receivedateformat>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugauthorizationnumb>6134</drugauthorizationnumb>
        <drugdosagetext>360 MG, PO</drugdosagetext>
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        <drugindication>DRUG THERAPY</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BROMAZEPAM (BROMAZEPAM)</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
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        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COCAINE (COCAINE)</medicinalproduct>
        <drugdosagetext>PE</drugdosagetext>
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  <safetyreport>
    <safetyreportid>4521199-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
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      <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>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RENAL COLIC</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
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    <safetyreportid>4521200-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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      <qualification>5</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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        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugindication>ARTHRALGIA</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND CODEINE PHOSPHATE</medicinalproduct>
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  <safetyreport>
    <safetyreportid>4521201-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
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    <companynumb>AU-MERCK-0412AUS00034</companynumb>
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      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
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        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
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        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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    <safetyreportid>4521202-X</safetyreportid>
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      <qualification>5</qualification>
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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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        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugindication>ARTHRITIS</drugindication>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
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      <qualification>4</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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
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        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
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        <drugcharacterization>1</drugcharacterization>
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    <safetyreportid>4521204-3</safetyreportid>
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      <qualification>5</qualification>
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    <sender>
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        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
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    <patient>
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      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521206-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00046</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521207-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0412CAN00027</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040814</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521208-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00019</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030825</drugenddate>
        <drugtreatmentduration>225</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030825</drugenddate>
        <drugtreatmentduration>225</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521209-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12206RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugauthorizationnumb>6134</drugauthorizationnumb>
        <drugdosagetext>115 MG, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>1 G</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521210-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00226</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521211-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0412FRA00008</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLAT FEET</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PILONIDAL CYST CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040326</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040212</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUSIDATE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040109</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040330</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFUROXIME</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITIOMETAN MAGNESIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICLOTYMOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBROXOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND CAFFEINE AND PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521212-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00219</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521213-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-MERCK-0412NOR00009</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMATROPIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD GROWTH HORMONE ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521214-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0412CAN00026</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521215-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00189</companynumb>
    <primarysource>
      <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>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521216-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00442</companynumb>
    <primarysource>
      <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>731</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521217-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00233</companynumb>
    <primarysource>
      <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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521218-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12205RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugauthorizationnumb>6134</drugauthorizationnumb>
        <drugdosagetext>130 MG, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYTONADIONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521219-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00319</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521220-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0412USA00293</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521221-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00475</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521222-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00473</companynumb>
    <primarysource>
      <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>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521223-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00049</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521224-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00457</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>32</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL CANDIDIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521225-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00403</companynumb>
    <primarysource>
      <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>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521226-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00538</companynumb>
    <primarysource>
      <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>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL MSD</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521227-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE03683</companynumb>
    <primarysource>
      <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 PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STROKE IN EVOLUTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugbatchnumb>4G401</drugbatchnumb>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugbatchnumb>U0062</drugbatchnumb>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521228-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12204RO</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 INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugauthorizationnumb>6134</drugauthorizationnumb>
        <drugdosagetext>140 MG, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>1 G</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR (ABACAVIR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE (LAMIVUDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPINAVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521229-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12209RO</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 INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugauthorizationnumb>6134</drugauthorizationnumb>
        <drugdosagetext>45 MG, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOCONAZOLE TABLETS, 100 MG (FLUCONAZOLE)</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATOVAQUONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521230-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12208RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugauthorizationnumb>6134</drugauthorizationnumb>
        <drugdosagetext>80 MG, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>60 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUTAMIRATE (BUTAMIRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521231-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040401261</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCOMMODATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGLE CLOSURE GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>NEUROPATHIC PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521232-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040906347</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAZE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODDING OF HEAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING PROJECTILE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MIGRAINE PROPHYLAXIS</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521233-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040901274</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521234-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-240819</companynumb>
    <primarysource>
      <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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>8 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>38880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR FLEXPEN</medicinalproduct>
        <drugdosagetext>14 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>38880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521235-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12207RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugauthorizationnumb>6134</drugauthorizationnumb>
        <drugdosagetext>90 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>3 IN 1 WK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDINAVIR (INDINAVIR)</medicinalproduct>
        <drugdosagetext>600 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE (LAMIVUDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521236-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12210RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugauthorizationnumb>6134</drugauthorizationnumb>
        <drugdosagetext>14 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>3 IN 1 WK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLINE-CLAVULANATE (AMOXI-CLAVULANICO)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPENEM (IMIPENEM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521237-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-FRA-06713-01</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>1 TABLET QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPTICUR (TROPATEPINE HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>10 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLEET PHOSPHO-SODA     DEWITT</medicinalproduct>
        <drugdosagetext>1 ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>1 QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XAGRID</medicinalproduct>
        <drugdosagetext>12 TABLET QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XAGRID</medicinalproduct>
        <drugdosagetext>12 TABLET QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL THROMBOCYTHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XAGRID</medicinalproduct>
        <drugindication>BLOOD DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XAGRID</medicinalproduct>
        <drugindication>ESSENTIAL THROMBOCYTHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXAPINE SUCCINATE</medicinalproduct>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDREA</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521238-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20040907351</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521239-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041200461</companynumb>
    <primarysource>
      <qualification>5</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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521240-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>041118-0000489</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTOBARBITAL SODIUM ([PENTOBARBITAL SODIUM)</medicinalproduct>
        <drugauthorizationnumb>83246</drugauthorizationnumb>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIAZOLAM</medicinalproduct>
        <drugdosagetext>0.25 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BROMAZEPAM (BROMAZEPAM)</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521241-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>041118-0000488</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTOBARBITAL SODIUM (PENTOBARBITAL SODIUM)</medicinalproduct>
        <drugauthorizationnumb>83246</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521242-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>Z002-353-0013</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLEX PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTICTAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521243-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-DE-05906GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYOSCINE HBR HYT</medicinalproduct>
        <drugdosagetext>20 MG (29 MG ONCE), IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BILIARY COLIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC (DICLOFENAC)</medicinalproduct>
        <drugdosagetext>75 MG (75 MC, ONCE), IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BILIARY COLIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521244-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RO-SOLVAY-00204004235</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25133</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040416</drugenddate>
        <drugtreatmentduration>354</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED THERAPY (PERINDOPRIL VS PLACEBO)</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 8 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040416</drugenddate>
        <drugtreatmentduration>345</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDUCTAL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040416</drugenddate>
        <drugtreatmentduration>354</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040416</drugenddate>
        <drugtreatmentduration>351</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040416</drugenddate>
        <drugtreatmentduration>345</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521245-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>R301137-3002-CDN</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>E3810(RABEPRAZOLE)</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521246-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05485</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>500 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>30 FRACTIONS OF 2 GY, TOTAL AMOUNT = 60 GY</drugdosagetext>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAPRED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRALYSAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521247-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02206</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugdosagetext>20 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NILEVAR</medicinalproduct>
        <drugindication>BONE MARROW DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NILEVAR</medicinalproduct>
        <drugdosagetext>1 DF DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE MARROW DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIFLOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIENAM /SCH/</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>2 G TID IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRICANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE HEMISUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOCILLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID HUMAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACUPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPNOVEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521248-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040923</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US10345</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
        <drugtreatmentduration>81</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521249-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02349</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugdosagetext>20 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>5 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>6 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>3 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYOSTACINE</medicinalproduct>
        <drugdosagetext>500 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERYSIPELAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>1 DF DAILY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>500 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521250-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02020</companynumb>
    <primarysource>
      <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>BLOOD IMMUNOGLOBULIN A INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN G INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN M INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521251-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041200894</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521252-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004PK01733</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugdosagetext>40 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>800 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugdosagetext>150 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCOUMAR</medicinalproduct>
        <drugdosagetext>3 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELOC ZOK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOREM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521253-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02343</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugdosagetext>1 DF DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEBUTID</medicinalproduct>
        <drugdosagetext>2 DF DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521254-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02345</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>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugdosagetext>40 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521255-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041106511</companynumb>
    <primarysource>
      <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>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRIDOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030529</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAHISTINE MESILATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030530</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMEBUTINE MALEATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCREATIC ENZYME COMBINED DRUG</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030531</drugenddate>
        <drugtreatmentduration>205</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOPENAC SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030531</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030531</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030531</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030531</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521256-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041200360</companynumb>
    <primarysource>
      <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>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
        <drugdosagetext>12-16 DAILY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA BLOCKER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521257-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>K200401810</companynumb>
    <primarysource>
      <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>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>19901</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOHEXAL (METOPROLOL TARTRATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521258-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040220</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0500185A</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF DESPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521259-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040617</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0515139A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOUS MEMBRANE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLAR CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASODILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EX-SMOKER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000727</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZMACORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521260-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0523781A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHAPPED LIPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVEDO RETICULARIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH SCALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040818</drugstartdate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521261-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0526867A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISINHIBITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521262-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JPKYO-S-20040036</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugdosagetext>25MGM2 PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORNER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANPLAG</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521263-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0533147A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521264-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JPKYO-S-20040044</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040430</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTROGIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040508</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521265-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JPKYO-S-20040045</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugdosagetext>25MGM2 CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN INJ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOKUNALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521266-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535379A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521267-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535401A</companynumb>
    <primarysource>
      <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>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521268-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535596A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521269-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEPFP-S-20040043</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521270-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEPFP-S-20040045</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521271-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-0273</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO REACTION ON PREVIOUS EXPOSURE TO DRUG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAINFUL RESPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANIPLEX</medicinalproduct>
        <drugdosagetext>25MGML SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLACTIC CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID</medicinalproduct>
        <drugindication>PROPHYLACTIC CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521272-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0348894A</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC VARICES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL VARICES HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
        <drugtreatmentduration>187</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521273-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0350764A</companynumb>
    <primarysource>
      <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>CARDIOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugdosagetext>150MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTISKENAN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTHACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTHACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521274-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0351020A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXOTAN</medicinalproduct>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040518</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521275-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0351105A</companynumb>
    <primarysource>
      <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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEARFULNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERBAL ABUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521276-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>4722</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYCAMTIN</medicinalproduct>
        <drugdosagetext>1.5MGM2 PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHABDOMYOSARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521277-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRPFM-E-20040127</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUNGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIBLOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTISKENAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIPROFENID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS EXTERNA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMALINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS EXTERNA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DRUG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521278-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0358307A</companynumb>
    <primarysource>
      <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>UTERINE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521279-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0358308A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521280-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>12623575</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B E ANTIGEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B SURFACE ANTIGEN POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040816</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521281-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRPFM-E-20040127 - V001</companynumb>
    <primarysource>
      <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 UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUNGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIBLOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIPROFENID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS EXTERNA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTISKENAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040402</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZALDIAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMALINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS EXTERNA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521282-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-GLAXOSMITHKLINE-B0358914A</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521283-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-GLAXOSMITHKLINE-B0358956A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugdosagetext>100MCG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521284-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>K200401809</companynumb>
    <primarysource>
      <qualification>3</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>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>19901</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERVOXAN (VINBURNINE) CAPSULE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEMIGOXINE NATIVELLE (DIGOXIN) TABLET</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN (FLUINDIONE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYPHYLLINE (ETOFYLLINE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIETARY SUPLEMMENTS )( 4U</medicinalproduct>
        <drugdosagetext>4 U, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040417</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521285-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-GLAXOSMITHKLINE-B0358984A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTANE</medicinalproduct>
        <drugdosagetext>2MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EXTRAPYRAMIDAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>8MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHIN</medicinalproduct>
        <drugdosagetext>1TAB THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINORRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521286-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0359079A</companynumb>
    <primarysource>
      <qualification>5</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>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEBRIDAT</medicinalproduct>
        <drugdosagetext>6UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORADRENALINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMPERAN</medicinalproduct>
        <drugdosagetext>3UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLUDACTONE</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SURBRONC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENTEROBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIFLOX</medicinalproduct>
        <drugdosagetext>400MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENTEROBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPNOVEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPHEDRINE SUL CAP</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521287-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-GLAXOSMITHKLINE-B0359142A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugdosagetext>1ML PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030221</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugdosagetext>2ML PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030221</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>1ML PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030221</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521288-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-GLAXOSMITHKLINE-B0359151A</companynumb>
    <primarysource>
      <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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTUM</medicinalproduct>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOCIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521289-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-GLAXOSMITHKLINE-B0359154A</companynumb>
    <primarysource>
      <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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORFIN</medicinalproduct>
        <drugdosagetext>5MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULATARD NPH HUMAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOGAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICART</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMLA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITUGG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XERODENT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPIKLON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521290-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>385859</companynumb>
    <primarysource>
      <qualification>1</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>DILATREND</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521291-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210679</companynumb>
    <primarysource>
      <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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY STEROID</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>375 MG, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROIDS NOS (STEROIDS NOS)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521292-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2004US00473</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENOCORTICAL INSUFFICIENCY ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>8 MG/DAILY</drugdosagetext>
        <drugindication>LIVER DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>16 MG/DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521293-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1669</companynumb>
    <primarysource>
      <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>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SARCOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIALOADENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAFERON (INTERFERON ALFA-2B) INJECTABLE SOLUTION</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>1000 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANTADIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521294-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TAP2004Q01539</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT-3</medicinalproduct>
        <drugauthorizationnumb>20517</drugauthorizationnumb>
        <drugdosagetext>22.5 MG, 1 IN 3 M, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521295-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1673</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugauthorizationnumb>20762</drugauthorizationnumb>
        <drugdosagetext>2/NARE BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYP</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521296-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP13286</companynumb>
    <primarysource>
      <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>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRADURAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIKOLSKY'S SIGN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>50 MG/DAY</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>PYELONEPHRITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040702</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PL GRAN.</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITH</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WYTENS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040702</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521297-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004US16080</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>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugdosagetext>1985 MCG/DAY</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugdosagetext>270 MCG/DAY</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521298-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004US16083</companynumb>
    <primarysource>
      <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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YAWNING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugdosagetext>129.6 UG/DAY</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521299-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004US16084</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521300-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-10-0829</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.4514</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL STOMA SITE BLEEDING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugauthorizationnumb>21165</drugauthorizationnumb>
        <drugdosagetext>1 TAB DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONES (NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNISOLIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521301-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1554</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>0.45 ML SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>800 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL ORALS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521302-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-05016</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOMIPRAMINE HYDROCHLORIDE (WATSON LABORATORIES) (CLOMIPRAMINE HYDROCH</medicinalproduct>
        <drugauthorizationnumb>74600</drugauthorizationnumb>
        <drugdosagetext>25 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSIVE SYMPTOM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE SUSTAINED RELEASE (BUPROPION HYDROCHLORIDE) TA</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSIVE SYMPTOM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521303-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004US16086</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521304-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004US16088</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASTICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521305-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE04021</companynumb>
    <primarysource>
      <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>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEEDING TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521306-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US07121</companynumb>
    <primarysource></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>OSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEBRIDEMENT</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>20011219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
        <drugtreatmentduration>889</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>5 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>75 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID AC</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521307-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12835</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>129</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>900 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>8 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521308-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004PL16328</companynumb>
    <primarysource>
      <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>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>3000 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521309-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030905</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2003GB03514</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON GANGRENE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>900MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMISULPRIDE</medicinalproduct>
        <drugdosagetext>400MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DUODENAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXATIVES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521310-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020920</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2002PL07013</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</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>BOWEL SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARBOHYDRATE ANTIGEN 125 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS ROTAVIRUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAD</medicinalproduct>
        <drugdosagetext>1.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>8 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521311-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP12761</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040211</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040211</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521312-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP14244</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugdosagetext>2 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugdosagetext>2 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAMAG G</medicinalproduct>
        <drugdosagetext>1.4 G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>1.5 G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRO-GRADUMET</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521313-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP14252</companynumb>
    <primarysource>
      <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>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIT</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521314-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP14245</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERIZYM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STROCAIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugdosagetext>.25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521315-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP14253</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>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODEOXYCHOLIC ACID</medicinalproduct>
        <drugdosagetext>3 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSPANON</medicinalproduct>
        <drugdosagetext>3 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTHMODAN</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUVOX</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>250 UG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521316-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2004AU01677</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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIPATCH</medicinalproduct>
        <drugdosagetext>50/140 UG</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521317-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16097</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SICK SINUS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521318-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP13059</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521319-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16096</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>2 TABLETS, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521320-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16102</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LENS DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEGRAN</medicinalproduct>
        <drugdosagetext>150 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEGRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>400 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521321-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CH08244</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>ANTICONVULSANT DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCHLORAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGEOMAS SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>600 TO 1200 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TEMPORAL LOBE EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19770101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>400 MG, TID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROVEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMIG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521322-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15797</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHERGINE</medicinalproduct>
        <drugdosagetext>375 UG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION SPONTANEOUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHERGINE</medicinalproduct>
        <drugdosagetext>375 UG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521323-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03141</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHERGINE</medicinalproduct>
        <drugdosagetext>.25 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POSTPARTUM HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521324-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004DZ03509</companynumb>
    <primarysource>
      <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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HYPOGLYCAEMIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
        <drugdosagetext>ONCE/SINGLE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521325-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03496</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCAPNIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEUROPERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERMIXON</medicinalproduct>
        <drugdosagetext>160 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MICTURITION DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
        <drugtreatmentduration>4380</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NISISCO</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BECOTIDE</medicinalproduct>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521326-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03463</companynumb>
    <primarysource></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>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDALIX</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAREG</medicinalproduct>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010428</drugenddate>
        <drugtreatmentduration>730</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>5 DF/WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010428</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521327-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12785820</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEPESID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521328-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12781829</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>SIX CYCLES ADMINISTERED FROM AN UNKNOWN DATE TO 15-NOV-2004</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521329-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP07535</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA HEPATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040511</drugenddate>
        <drugtreatmentduration>169</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031124</drugenddate>
        <drugtreatmentduration>46080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040511</drugenddate>
        <drugtreatmentduration>210</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040511</drugenddate>
        <drugtreatmentduration>210</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521330-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004IT16183</companynumb>
    <primarysource>
      <qualification>3</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDIASTINAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL CELL LUNG CANCER EXTENSIVE STAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521331-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP07373</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugdosagetext>10 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031229</drugenddate>
        <drugtreatmentduration>15840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENFILL R</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPERISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KINEDAK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMAGENIL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNASYN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVO HEPARIN CALCIUM</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031229</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521332-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004ES16369</companynumb>
    <primarysource>
      <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>ASPIRATION PLEURAL CAVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STI</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EWING'S SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521333-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004DE17156</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041030</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521334-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03489</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>805</patientonsetageunit>
      <patientweight>3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COARCTATION OF THE AORTA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL CARDIOVASCULAR ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZADITEN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AERIUS</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AERIUS</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRONCHODUAL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLIXONASE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELFAST</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELFAST</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521335-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030919</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-03P-087-0234687-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>AGE INDETERMINATE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030827</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGE INDETERMINATE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGE INDETERMINATE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGE INDETERMINATE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGE INDETERMINATE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521336-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0280120-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ALVEOLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
        <drugtreatmentduration>237</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA-ALANINE</medicinalproduct>
        <drugindication>HOT FLUSH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040626</drugenddate>
        <drugtreatmentduration>77</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521337-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0279605-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPRANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTRIVA</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>HYDRALAZINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAPROLOL XL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORACIT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN ALFA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILGRASTIM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521366-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0412GBR00015</companynumb>
    <primarysource>
      <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>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TROSPIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INCONTINENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</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>COD LIVER OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521367-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA02516</companynumb>
    <primarysource>
      <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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521369-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-MERCK-0411NLD00049</companynumb>
    <primarysource>
      <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>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
        <drugtreatmentduration>152</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521371-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040514</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0405FRA00052</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIAPHRAGMATIC PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUADRIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040429</drugenddate>
        <drugtreatmentduration>4503</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUINDIONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLECAINIDE ACETATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICARDIPINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICARDIPINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040430</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040430</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521372-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040323</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0403USA02294</companynumb>
    <primarysource>
      <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>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521373-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03877</companynumb>
    <primarysource>
      <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521374-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00821</companynumb>
    <primarysource>
      <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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGE INDETERMINATE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOID PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPERMATOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521378-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040903</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0409USA00401</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040827</drugenddate>
        <drugtreatmentduration>87</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </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>ALLEGRA-D</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521379-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0409FRA00105</companynumb>
    <primarysource>
      <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>GASTRIC VARICES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICES OESOPHAGEAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521380-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020411</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0204USA01392</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521381-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00043</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521383-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00806</companynumb>
    <primarysource>
      <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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521384-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA04359</companynumb>
    <primarysource>
      <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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521385-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-MERCK-0411CHN00084</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC PROTRUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521386-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0312USA00993</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEBORRHOEIC DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011217</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521387-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00037</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLORITAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET TABLETS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521389-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041003</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00044</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMMINUTED FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521390-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040716</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0407USA01419</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040712</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040712</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521393-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00057</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521394-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-MERCK-0412CHE00002</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521396-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA02581</companynumb>
    <primarysource>
      <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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521397-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0412GBR00011</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>1520</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521399-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00202</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>95</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NATRIURETIC PEPTIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIASTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE INVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUMBAR SPINAL STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VERTEBROPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521404-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00213</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521405-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00062</companynumb>
    <primarysource>
      <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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521407-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00169</companynumb>
    <primarysource>
      <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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521408-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00095</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </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>4521409-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00188</companynumb>
    <primarysource>
      <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>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521410-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00094</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521411-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03576</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521412-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00392</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521413-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00395</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521414-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00304</companynumb>
    <primarysource>
      <qualification>4</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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521415-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00231</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521417-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04093</companynumb>
    <primarysource>
      <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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521418-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00061</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521419-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00413</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>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521420-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00649</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521421-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00407</companynumb>
    <primarysource>
      <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>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521422-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00402</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521423-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00421</companynumb>
    <primarysource>
      <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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521424-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00517</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040919</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521430-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20011113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-01111701</companynumb>
    <primarysource>
      <qualification>4</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011113</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521433-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0302USA00069</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST WALL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPIL FIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ALKALOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORRECTOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYCOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010709</drugenddate>
        <drugtreatmentduration>119</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010709</drugenddate>
        <drugtreatmentduration>1210</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010301</drugenddate>
        <drugtreatmentduration>457</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521435-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0412CAN00031</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>1660</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521436-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0412CAN00033</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
        <drugtreatmentduration>1070</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>164</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
        <drugtreatmentduration>1070</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>164</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521556-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94.3482</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SILDENAFIL  40 MG TID</medicinalproduct>
        <drugbatchnumb>03-004374</drugbatchnumb>
        <drugdosagetext>40MG TID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDICAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METROLO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOCIN</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521557-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40MG, 40MG HS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521558-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.2554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZICAM   MAXIMM</medicinalproduct>
        <drugdosagetext>ONE SQUIRT    EACH NOSTRIL   NASAL</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZICAM   MAXIMM</medicinalproduct>
        <drugdosagetext>ONE SQUIRT    EACH NOSTRIL   NASAL</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041205</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521559-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE BURNING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL MUCOSAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EQUATE EXTRA MOISTURIZING NASAL SPRAY,  1.25 FL OZ</medicinalproduct>
        <drugbatchnumb>4JK0219</drugbatchnumb>
        <drugindication>NASAL CONGESTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521561-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521562-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.8529</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>10 MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521563-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN EXACERBATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugdosagetext>30 MG 2 Q AM 2 Q PM 1 QHS</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521564-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WINRHO</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521566-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </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>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIBRAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIBRAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521567-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW23940</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>13.607</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL ACTIVITY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521568-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24455</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>100 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521569-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24380</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBATROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521570-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24014</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.163</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>100 MG HS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521571-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KII-2004-0014143</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>SEE TEXT, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521572-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040910</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200408178</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>17.2367</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAZE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRIP STRENGTH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>380 UNITS DAILY IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COENZYME Q10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAROTENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINE E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN INFUSION (MVI)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521573-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12545</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISUDYNE</medicinalproduct>
        <drugauthorizationnumb>21119</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521574-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24004</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPRISONMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL ASSAULT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugauthorizationnumb>12703</drugauthorizationnumb>
        <drugdosagetext>25 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521575-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43.9989</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>ONE  EVERY NIGHT  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVOUSNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>ONE  EVERY NIGHT  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SOCIAL PHOBIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040725</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521576-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.173</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGORAPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF LIBIDO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL AVOIDANT BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>1 DAILY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>1 DAILY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STRESS SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521577-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521578-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugdosagetext>240 MG DAILY INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MENINGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugdosagetext>240 MG DAILY INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521579-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETACAINE SPRAY</medicinalproduct>
        <drugdosagetext>REPEATED DOSES ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGOLARYNGEAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521580-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugdosagetext>400MG   ONCE  INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521581-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugdosagetext>250MG   X1  INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521582-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB    100MG</medicinalproduct>
        <drugdosagetext>100MG  BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEET PHOSPHO SODA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISACODYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521583-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>139870USA</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJOINED TWINS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY OF PARTNER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSMISSION OF DRUG VIA SEMEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>20622</drugauthorizationnumb>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLERGY SHOT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521584-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KII-2004-0014071</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521585-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KII-2004-0014134</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE (CYCLOBENZAPRINE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521586-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KII-2004-0014116</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICOLOGIC TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORGANOPHOSPHATE AND OTHER INSECTICIDE()</medicinalproduct>
        <drugdosagetext>3 CAN, DAILY, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND OXYCODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521587-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KII-2000-0012700</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>19516</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521588-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096210</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNISOM</medicinalproduct>
        <drugbatchnumb>0104433</drugbatchnumb>
        <drugauthorizationnumb>18066</drugauthorizationnumb>
        <drugdosagetext>1 TABLET NIGHTLY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES (ANTIHYPERTENSIVES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTEROL- AND TRIGLYCERIDE REDUCERS (CHOLESTEROL- AND TRIGLYCERIDE </medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521589-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097653</companynumb>
    <primarysource></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>
        <drugbatchnumb>FD047B</drugbatchnumb>
        <drugauthorizationnumb>20385</drugauthorizationnumb>
        <drugdosagetext>4 PACKS IN 8 DAYS, NASAL</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521590-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004091855</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugbatchnumb>12744V</drugbatchnumb>
        <drugauthorizationnumb>5845</drugauthorizationnumb>
        <drugdosagetext>TWO ULTRATABS Q.D., ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521591-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.709</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugdosagetext>1        DAY    ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugdosagetext>1        DAY    ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521592-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.7403</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN    100 MG VIAL   SANOFI</medicinalproduct>
        <drugdosagetext>120 MG  EVERY 2-3 WEEK   INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLASETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521593-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.7403</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN   350 MG VIAL  BEDFORD</medicinalproduct>
        <drugdosagetext>380 MG   EVERY 2-3 WEEK   INTRAVENOU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN   350 MG VIAL  BEDFORD</medicinalproduct>
        <drugdosagetext>380 MG   EVERY 2-3 WEEK   INTRAVENOU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUORURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLASETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521594-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG   2/WEEK  SUBCUTANEO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521595-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>112.9457</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE   50MG   CELEGENE</medicinalproduct>
        <drugdosagetext>150 MG DAILY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521596-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugdosagetext>200MG   DAILY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521597-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugdosagetext>500 MG  QID   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYELONEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031222</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521598-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugdosagetext>400MG  DAILY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521599-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MC200400785</companynumb>
    <primarysource>
      <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>CARDIAC PROCEDURE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANGIOMAX</medicinalproduct>
        <drugauthorizationnumb>20873</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>CORONARY ANGIOPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANGIOMAX</medicinalproduct>
        <drugauthorizationnumb>20873</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>CORONARY ANGIOPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPTIFIBATIDE (EPTIFIBATIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521600-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097829</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISINE A (PEHIRAMINE MALEATE, NAPHAZOLINE HYDROCHLORIDE)</medicinalproduct>
        <drugbatchnumb>1003007</drugbatchnumb>
        <drugauthorizationnumb>20485</drugauthorizationnumb>
        <drugdosagetext>2 GTS OS ONCE, 2 GTS OD</drugdosagetext>
        <drugindication>EYE ALLERGY</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES (ANTIHYPERTENSIVES)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521601-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <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>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE 0.9 % IRRIGATION</medicinalproduct>
        <drugbatchnumb>C613745</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4521602-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>10066156-C613745-0</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERRATIA INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE 0.9 % IRRIGATION</medicinalproduct>
        <drugbatchnumb>C613745</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521603-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2004-0017874</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521604-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2004-0017876</companynumb>
    <primarysource>
      <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>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugindication>CANCER PAIN</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521605-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041106234</companynumb>
    <primarysource>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</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>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABUMETONE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521606-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041106314</companynumb>
    <primarysource>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4521607-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041106341</companynumb>
    <primarysource>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BOWEN'S DISEASE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABUMETONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIHYDROCODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4521608-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041106530</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</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>CO-PROXAMOL</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>4521609-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-JNJFOC-20041106539</companynumb>
    <primarysource>
      <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>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>2 INFUSIONS ADMINISTERED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIGRAN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIGRAN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIGRAN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIGRAN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4521610-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041106541</companynumb>
    <primarysource>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>109</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BOWEN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>4521611-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
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    <receivedateformat>102</receivedateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20041106544</companynumb>
    <primarysource>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EMPYEMA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
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  <safetyreport>
    <safetyreportid>4521612-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
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      <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>CHEST DISCOMFORT</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
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        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20041200020</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTIOUS MONONUCLEOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FISTULA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521614-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041200172</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>BREAST DISORDER MALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROADENOMA OF BREAST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521615-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041200449</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS CRYPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521616-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105212</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</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>FIRST INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10MG ALTERNATING 7.5MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugdosagetext>1/2 TAB EVERY EVENING.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>2 EVERY DAY.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLORINEF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVON</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521617-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105211</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOLD</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS ULTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521618-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20041007640</companynumb>
    <primarysource>
      <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>LYMPHANGIOSIS CARCINOMATOSA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521619-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041002232</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.31</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>04E077A</drugbatchnumb>
        <drugdosagetext>350MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521620-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2004-0016892</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>SEE TEXT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>10 MG, HS</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE (SERTRALINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDRODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT (IPRATOPIUM BROMIDE, SALBUTAMOL SULFATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521621-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2004-0017775</companynumb>
    <primarysource>
      <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>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOE AMPUTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPECTRACEF</medicinalproduct>
        <drugauthorizationnumb>21222</drugauthorizationnumb>
        <drugdosagetext>MG</drugdosagetext>
        <drugindication>INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521622-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.6892</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugdosagetext>20 MG QD  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040229</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521623-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>24MG  Q6H    INTRAVENOU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SPINAL CORD INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521624-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.5349</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM CD    180 MG   ?</medicinalproduct>
        <drugdosagetext>1  DAILY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521625-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.4003</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>20 MG  QD  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040809</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521626-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.3273</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugindication>APPENDICECTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040715</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521627-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.7611</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOSTINEX</medicinalproduct>
        <drugdosagetext>1.5 MG   TWICE A WEEK   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PROLACTIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040413</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521628-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>21.7727</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugdosagetext>17 GRAMS   PER DAY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugdosagetext>17 GRAMS   PER DAY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041210</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521629-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.1939</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUNNEL VISION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB    200MG   HOUSTON VA</medicinalproduct>
        <drugdosagetext>200MG  TWICE PER DAY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB    200MG   HOUSTON VA</medicinalproduct>
        <drugdosagetext>200MG  TWICE PER DAY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARAPARESIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040221</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521630-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-26</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521631-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-25</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521632-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-64</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZONATATE</medicinalproduct>
        <drugauthorizationnumb>11210</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GUAIFENESIN W/DEXTROMETHORPHAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOBENZARINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521633-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-05541-01</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.3597</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLONIC CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TESSALON</medicinalproduct>
        <drugauthorizationnumb>11210</drugauthorizationnumb>
        <drugdosagetext>1000 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TESSALON</medicinalproduct>
        <drugdosagetext>1000 MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040806</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521634-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-06</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN/DIPHENHYDRAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARISORPODOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEPROBAMATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521635-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-04</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521636-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-03</companynumb>
    <primarysource>
      <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>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BOWEL SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARBON MONOXIDE POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABILE BLOOD PRESSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBON MONOXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VODKA (ALCOHOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521637-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04110323</companynumb>
    <primarysource>
      <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>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040412</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521638-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04110633</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521639-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04120043</companynumb>
    <primarysource>
      <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 POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL PILLS (ORAL CONTRACEPTIVE NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521640-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRUXISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20MG  QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20MG  QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521641-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IND-AE-04-SAN-019</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.1428</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANCTURA</medicinalproduct>
        <drugauthorizationnumb>21595</drugauthorizationnumb>
        <drugdosagetext>20 MG - QD - ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521642-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugdosagetext>400MG,200MG BI, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HCTZ 25/TRIAMTERENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNISOLIDE/MENTHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DM 10/GUAIFENESIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521643-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-07133-01</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42.6381</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugbatchnumb>120317</drugbatchnumb>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugdosagetext>15 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>5 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521644-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.2867</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>2000 MG</drugdosagetext>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521645-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RS004835-USA</companynumb>
    <primarysource>
      <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>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521646-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIOPSY SKIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOSARCOMA METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>2440 MG</drugdosagetext>
        <drugindication>METASTATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>2440 MG</drugdosagetext>
        <drugindication>SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>2440 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521647-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12188RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugauthorizationnumb>74069</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugauthorizationnumb>74069</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB (INFLIXIMAB)</medicinalproduct>
        <drugdosagetext>5 MG/KG AT 0, 2, 6 WEEKS LOADING THEN Q 8 WEEKS, IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521648-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-58</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM (LONG-ACTING) (DILTIAZEM)</medicinalproduct>
        <drugauthorizationnumb>20401</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521649-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-57</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM (LONG-ACTING) (DILTIAZEM)</medicinalproduct>
        <drugauthorizationnumb>20401</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521650-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410737BNE</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75 MG, TOTAL DIALY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521651-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410639BYL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521652-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200411019BVD</companynumb>
    <primarysource></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>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISCLERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA NODOSUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPROLACTINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RAYNAUD'S PHENOMENON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROIDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>19847</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MASTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MASTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040829</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521653-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410405BFR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYME DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALTOR (CERIVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20740</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALTOR (CERIVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20740</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALTOR (CERIVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20740</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPANTHYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEFIZAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXEPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FONLIPOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDIATOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERMION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLEA EUROPAE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APRANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521654-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410608BYL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugauthorizationnumb>20198</drugauthorizationnumb>
        <drugdosagetext>60 MG , TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMETEC (OLMESARTAN MEDOXOMIL)</medicinalproduct>
        <drugdosagetext>20 MG , BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PURSENNID (SENNA ALEXANDRINA LEAF)</medicinalproduct>
        <drugdosagetext>36 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERSANTIN</medicinalproduct>
        <drugdosagetext>12.5 MG, TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON-VG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILTAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRORENAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZELASTINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521655-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410614BFR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugauthorizationnumb>19537</drugauthorizationnumb>
        <drugdosagetext>1500 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOCILLINE</medicinalproduct>
        <drugdosagetext>12 G, TOTAL DAILY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARDENALE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OFLOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521656-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE06491</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>100 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugdosagetext>2 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521657-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24375</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>300 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521658-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETIRIZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521659-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02800</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PROLACTIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>25 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521660-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24114</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.3377</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLENDIL</medicinalproduct>
        <drugauthorizationnumb>19834</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO MATCH</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521661-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugdosagetext>80 MG (2 X 40 MG) DAILY</drugdosagetext>
        <drugindication>FACE OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521662-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521663-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>BONTRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521664-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RS004703-J</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD IRON INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAPTOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCHROMIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETICULOCYTE COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA (FERROUS CITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANIRAPID (METILDIGOXIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLUTAL (BLUTAL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALOMIDE (COBAMAMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERO-GRADUMET (FERROUS SULFATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521665-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24314</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAMPYLOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugdosagetext>20 DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521666-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02348</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>15 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROVEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDIPATCH</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521667-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24517</companynumb>
    <primarysource></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>TRISOMY 13</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>19726</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521668-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05580</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugauthorizationnumb>18240</drugauthorizationnumb>
        <drugdosagetext>25 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDENALIN</medicinalproduct>
        <drugdosagetext>2 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEROCRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521669-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05212</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>500 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>500 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>60 GUY IN 30 FRACTIONS OVER 6 WEEKS</drugdosagetext>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRADOLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDAPSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAPRED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOSTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521670-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZONI002059</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEGRAN (ZONISAMIDE)</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LENNOX-GASTAUT SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521671-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05862</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521672-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZONI002066</companynumb>
    <primarysource>
      <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>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEGRAN (ZONISAMIDE)</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>100 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUBDURAL HAEMATOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOCKLIN-L (PINDOLOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALSLOT (MANIDIPINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADECUT (DELAPRIL HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521673-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP06097</companynumb>
    <primarysource></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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521674-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12181RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE ABNORMAL</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>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN TABLETS USP, 250MG (CLARITHROMYCIN)</medicinalproduct>
        <drugauthorizationnumb>65178</drugauthorizationnumb>
        <drugdosagetext>1 G</drugdosagetext>
        <drugindication>GASTRITIS EROSIVE</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN TABLETS USP, 250MG (CLARITHROMYCIN)</medicinalproduct>
        <drugauthorizationnumb>65178</drugauthorizationnumb>
        <drugdosagetext>1 G</drugdosagetext>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLCHICINE (COLCHICINE)</medicinalproduct>
        <drugdosagetext>1.5 MG, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FAMILIAL MEDITERRANEAN FEVER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>2 G</drugdosagetext>
        <drugindication>GASTRITIS EROSIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>2 G</drugdosagetext>
        <drugindication>HELICOBACTER INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugindication>GASTRITIS EROSIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugindication>HELICOBACTER INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEBUTOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOLSIDOMINE (MOLSIDOMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC (ACETYLSALICYLIC SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521675-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW23446</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>127.0072</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOTAL CHOLESTEROL/HDL RATIO ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEXPECTED THERAPEUTIC DRUG EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG DAILY PO</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521676-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24169</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</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 AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>30 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521677-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE06525</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRABISMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugdosagetext>8 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugdosagetext>8 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMASPAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521678-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-49</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugauthorizationnumb>20401</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARISOPRODOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEPROBAMATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521679-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12163RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugauthorizationnumb>75129</drugauthorizationnumb>
        <drugdosagetext>200 MCG, IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521680-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-48</companynumb>
    <primarysource>
      <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>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QRS COMPLEX PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugauthorizationnumb>20401</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIVATED CHARCOAL (CHARCOAL, ACTIVATED)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521681-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004242965JP</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>20753</drugauthorizationnumb>
        <drugdosagetext>25 MG (25 MG, DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER FEMALE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugdosagetext>(90 MG) INTR-</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM (LOXOPROFEN SODIUM)</medicinalproduct>
        <drugdosagetext>180 MG (60 MG, THREE TIMES DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICAFUNGIN (MICAFUNGIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521682-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12162RO</companynumb>
    <primarysource></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>ALBUTEROL</medicinalproduct>
        <drugauthorizationnumb>75129</drugauthorizationnumb>
        <drugdosagetext>1.5 MG OVER 9 HOURS, IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STATUS ASTHMATICUS</drugindication>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMINOPHYLLINE ORAL SOLUTION USP, 105MG/5ML (AMINOPHYLLINE)</medicinalproduct>
        <drugdosagetext>1.7 MG OVER 9 HOURS, IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STATUS ASTHMATICUS</drugindication>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugdosagetext>400 MG OVER 9 HOURS</drugdosagetext>
        <drugindication>STATUS ASTHMATICUS</drugindication>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521683-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-20</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugauthorizationnumb>21116</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521684-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210824</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugdosagetext>60 MG/M2, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOFOSFAMIDE (CYCLOPHOSPHAMIDE)</medicinalproduct>
        <drugdosagetext>600 MG/M2, Q3W</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040715</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521685-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-02</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugauthorizationnumb>21116</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHYLENE GLYCOL (POLYETHYLENE GLYCOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521686-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003AP03972</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>100 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>100 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HALLUCINATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELESMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAMALIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521687-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12161RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLLAPSE OF LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG HYPERINFLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugauthorizationnumb>75129</drugauthorizationnumb>
        <drugdosagetext>5 MG Q2H X 6 DOSES (SEE TEXT), IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE (ALENDRONATE SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521688-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05954</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCAINE</medicinalproduct>
        <drugauthorizationnumb>71202</drugauthorizationnumb>
        <drugdosagetext>4 ML ONCE ED</drugdosagetext>
        <drugindication>INTERVERTEBRAL DISC PROTRUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCAINE</medicinalproduct>
        <drugauthorizationnumb>71202</drugauthorizationnumb>
        <drugdosagetext>4 ML ONCE ED</drugdosagetext>
        <drugindication>SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521689-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-38</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugauthorizationnumb>88320</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521690-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200418658US</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521691-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413141JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANDA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040323</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521692-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413514EU</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521693-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200412745DE</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521694-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12166RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugauthorizationnumb>75129</drugauthorizationnumb>
        <drugdosagetext>5 MG EVERY 4 HOURS FOR 5 DOSES (5 MG, 1 IN 4 HR)</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMINOPHYLLINE ORAL SOLUTION USP, 105MG/5ML (AMINOPHYLLINE)</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (CORTICOSTEROIDS)</medicinalproduct>
        <drugdosagetext>HIGH DOSES</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521695-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-42</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugauthorizationnumb>88320</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ PROPOXYPHENE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521696-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-41</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugauthorizationnumb>88320</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ PROPOXYPHENE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521697-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-43</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugauthorizationnumb>88320</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521698-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>258 MG IV, 259 MG IV, 252 MG IV, 250 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>258 MG IV, 259 MG IV, 252 MG IV, 250 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>258 MG IV, 259 MG IV, 252 MG IV, 250 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>258 MG IV, 259 MG IV, 252 MG IV, 250 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>129 MG IV, 129 MG IV, 126 MG IV, 125 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521699-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.4827</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIRECTAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugdosagetext>57 MG</drugdosagetext>
        <drugindication>SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugdosagetext>4800 MG</drugdosagetext>
        <drugindication>SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521700-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-08</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugauthorizationnumb>72499</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521701-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>BLOOD LACTIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID 600 MG Q 12 H IV + PO DIFERENT TIMES</medicinalproduct>
        <drugdosagetext>600 MG IV Q 12</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CELLULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID 600 MG Q 12 H IV + PO DIFERENT TIMES</medicinalproduct>
        <drugdosagetext>600 MG IV Q 12</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID 600 MG Q 12 H IV + PO DIFERENT TIMES</medicinalproduct>
        <drugdosagetext>600 MG IV Q 12</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID 600 MG Q 12 H IV + PO DIFERENT THIS</medicinalproduct>
        <drugdosagetext>CHANGED TO PO Q 12 AT ONE POINT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040805</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521702-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW21554</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugindication>DENTAL OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO MATCH</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521703-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02779</companynumb>
    <primarysource>
      <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 CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMYALGIA RHEUMATICA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521704-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.9572</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICROGESTIN 28 DAY</medicinalproduct>
        <drugdosagetext>1 PO Q DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521705-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>154.223</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugdosagetext>1 PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521706-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>25 MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040820</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521707-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>26.0818</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATOMOXETINE 25 MG</medicinalproduct>
        <drugdosagetext>10 MG STARTING 11/3/04, THEN 25MG 1 PO Q DAY STARTING 11/16/04</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521708-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1476</companynumb>
    <primarysource>
      <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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELESTAMINE TAB</medicinalproduct>
        <drugauthorizationnumb>14215</drugauthorizationnumb>
        <drugdosagetext>1 TAB ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNSPECIFIED THERAPEUTIC AGENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521709-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-05</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugauthorizationnumb>72499</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521710-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.2554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANDASARTAN 16 MG DAILY</medicinalproduct>
        <drugdosagetext>16 MG PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </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>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521711-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-05-1987</companynumb>
    <primarysource>
      <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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>600 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>10 MU 6-3/WK* INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030926</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521712-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-60</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugauthorizationnumb>72499</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521713-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-03P-056-0208588-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021213</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPRANAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOXOPLASMOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521714-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-61</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugauthorizationnumb>72499</drugauthorizationnumb>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOMIPRAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521715-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-62</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugauthorizationnumb>72499</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521716-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ABBOTT-04P-008-0280766-00</companynumb>
    <primarysource></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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA HEPATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOPHTHALMOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATORENAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAMMONAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
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        <drugstartdate>20040229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040510</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugindication>EPILEPSY</drugindication>
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        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBIMAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTHYROIDISM</drugindication>
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        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040510</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
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        <drugstartdate>20040318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040510</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040510</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>OESOPHAGEAL DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040510</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040510</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521717-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
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    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <companynumb>US-ABBOTT-04P-163-0281495-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PNEUMONIA</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>20031101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
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  <safetyreport>
    <safetyreportid>4521718-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0281846-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPALGIC</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521719-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0278595-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.174</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HYPERTRIGLYCERIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>152</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521720-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040302</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0252002-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040114</drugenddate>
        <drugtreatmentduration>128</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPRANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040114</drugenddate>
        <drugtreatmentduration>128</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040114</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIQUID NUTRITIONAL SUPPLEMENT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NUTRITIONAL SUPPORT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URTICARIA CHOLINERGIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNISOLIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040105</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521721-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-63</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugauthorizationnumb>72499</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521722-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20021223</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ABBOTT-02P-151-0206816-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA PRIMARY ATYPICAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG WITHDRAWAL MAINTENANCE THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURAZEPAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521723-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-35</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugauthorizationnumb>88320</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521724-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-30</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugauthorizationnumb>88320</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESIPRAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521725-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12754</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIP NEOPLASM MALIGNANT STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugdosagetext>200 IU, QD</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521726-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1492</companynumb>
    <primarysource>
      <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>ANOSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugauthorizationnumb>20762</drugauthorizationnumb>
        <drugdosagetext>2PUFF/NARE QD NASAL SPRAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>RHINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIBROCIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CROMOLYN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521727-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12876</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGGER FINGER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugdosagetext>200 IU, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugtreatmentduration>547</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521728-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04428</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>75 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>10MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521729-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1497</companynumb>
    <primarysource>
      <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>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELESTAMINE TAB</medicinalproduct>
        <drugauthorizationnumb>14215</drugauthorizationnumb>
        <drugdosagetext>1 TAB ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNSPECIFIED THERAPEUTIC AGENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521730-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097849</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.8748</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>08014</drugbatchnumb>
        <drugdosagetext>(2MG) 1 PIECE 4-5 TIMES DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugdosagetext>1-2 INHALATIONS IN THE MORNINGS, INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENZYMES (ENZYMES)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521731-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003-06-1912</companynumb>
    <primarysource>
      <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>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>6 MU 6X/WK INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521732-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-10-0171</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELESTAMINE TAB</medicinalproduct>
        <drugauthorizationnumb>14215</drugauthorizationnumb>
        <drugdosagetext>1 TABLET ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ECZEMA ASTEATOTIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZELASTINE TABLETS</medicinalproduct>
        <drugdosagetext>2 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ECZEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAVINE ADENINE DINUCLEOTID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXAL PHOSPHATE TABLETS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521733-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-0850</companynumb>
    <primarysource>
      <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>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521734-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_25428_2004</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEVETEN</medicinalproduct>
        <drugauthorizationnumb>20738</drugauthorizationnumb>
        <drugdosagetext>600 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVIRAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521735-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_25427_2004</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEVETEN</medicinalproduct>
        <drugauthorizationnumb>20738</drugauthorizationnumb>
        <drugdosagetext>600 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAFORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLPRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521736-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004-1805</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugauthorizationnumb>75903</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>SINGLE DOSE OF 10 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POST PROCEDURAL VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPIVACAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPIVACAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521737-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004-1807</companynumb>
    <primarysource>
      <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>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NYDRAZID (ISONIAZID)</medicinalproduct>
        <drugauthorizationnumb>8662</drugauthorizationnumb>
        <drugindication>DISSEMINATED TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIMACTANE</medicinalproduct>
        <drugindication>DISSEMINATED TUBERCULOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521738-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-12776969</companynumb>
    <primarysource>
      <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>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELEPARINA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521739-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12786372</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521740-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12784971</companynumb>
    <primarysource>
      <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>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FARMORUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPHREN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLUDECADRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521741-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-12770723</companynumb>
    <primarysource>
      <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>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugdosagetext>THERAPY INTERRUPTED 05-NOV-2004, RESTARTED ON 02-DEC-2004</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugdosagetext>THERAPY INTERRUPTED 05-NOV-2004</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugdosagetext>THERAPY INTERRUPTED 05-NOV-2004</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970918</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521742-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004US16190</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN G INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN M INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIFE SUPPORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRACHEOSTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEST NILE VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521743-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-2004-025706</companynumb>
    <primarysource>
      <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>BLOOD FOLATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IRON DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC POLYPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAPTOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOTALOL (SOTALOL HYDROCHLORIDE) TABLET</medicinalproduct>
        <drugauthorizationnumb>19865</drugauthorizationnumb>
        <drugdosagetext>80 MG, 1X/DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATHYMIL (MIANSERIN HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>30 MG, 1X/DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct> DOLIPRANE (PARACETAMOL) EFFERVESCENT TABLET</medicinalproduct>
        <drugdosagetext>500 MG, 2X/DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY, ORAL</drugdosagetext>
        <drugadministrationroute>046</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>1.25 MG1X/DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECAPEPTYL - SLOW RELEASE (TRIPTORELIN ACETATE)</medicinalproduct>
        <drugdosagetext>3 MG, 1X/DAY, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASASANTIN (ACETYLSALICYLIC ACID, DIPYRIDAMOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL ^SERVIER^ (TRIMETAZIDINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRINIPATCH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE DISKUS (SALMETEROL XINAFOATE, FLUTICASONE PROPIONATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521744-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004-1806</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDUCTION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugauthorizationnumb>70302</drugauthorizationnumb>
        <drugdosagetext>OVERDOSE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE</medicinalproduct>
        <drugdosagetext>OVERDOSE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521745-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-37</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugauthorizationnumb>88320</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521746-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-382034</companynumb>
    <primarysource>
      <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>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521747-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-66</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugauthorizationnumb>20401</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEZTROPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521748-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-59</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugauthorizationnumb>20401</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521749-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-52</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugauthorizationnumb>20401</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521750-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-51</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugauthorizationnumb>20401</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521751-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-50</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugauthorizationnumb>20401</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521752-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-54</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugauthorizationnumb>20401</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN/TRAMADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521753-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12165RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugauthorizationnumb>75129</drugauthorizationnumb>
        <drugdosagetext>60 MG OVER 24 HOURS, IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STATUS ASTHMATICUS</drugindication>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521754-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-53</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM (LONG-ACTING) (DILTIAZEM)</medicinalproduct>
        <drugauthorizationnumb>20401</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521755-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-56</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugauthorizationnumb>20401</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521756-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12164RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugauthorizationnumb>75129</drugauthorizationnumb>
        <drugdosagetext>10 MG IN 5 ML NACL 0.9 % X 3 DOSES (10 MG), IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521757-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-SOLVAY-00304004110</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUVOX</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 200 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUVOX</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521758-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419149US</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNIK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521759-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040812</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200416087US</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521760-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413626FR</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERWEIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFU K</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521761-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200420202GDDC</companynumb>
    <primarysource>
      <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>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEXOFENADINE HCL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESALEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYZAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROVEL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521762-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-55</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugauthorizationnumb>20401</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521763-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12167RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugauthorizationnumb>75129</drugauthorizationnumb>
        <drugdosagetext>35 MG OVER 48 HRS PER INFUSION, IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMATURE LABOUR</drugindication>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521764-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-24</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION (LONG ACTING) (BUPROPION)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521765-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-36</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugauthorizationnumb>88320</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521766-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-10056RO</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>72734</drugauthorizationnumb>
        <drugdosagetext>75 MG/DAY, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UFT</medicinalproduct>
        <drugdosagetext>3 G/DAY, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIO-THREE (BIO THREE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521767-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-19</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521768-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-40</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugauthorizationnumb>88320</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521769-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-32</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM (ESCITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIOTHYRONINE (LIOTHYRONINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521770-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-39</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugauthorizationnumb>88320</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521771-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-31</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM (ESCITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXEPIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521772-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AL001580</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERAX</medicinalproduct>
        <drugauthorizationnumb>15539</drugauthorizationnumb>
        <drugdosagetext>45 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAROXYL</medicinalproduct>
        <drugdosagetext>BID; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUSOPT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521773-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-47</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugauthorizationnumb>20401</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521774-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-65</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521775-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-46</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugauthorizationnumb>20401</drugauthorizationnumb>
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    </patient>
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  <safetyreport>
    <safetyreportid>4521776-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-13</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </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>BRAIN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>70231</drugauthorizationnumb>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4521777-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
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    <receiptdate>20041118</receiptdate>
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    <companynumb>L04-USA-07403-45</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugauthorizationnumb>20401</drugauthorizationnumb>
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    </patient>
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  <safetyreport>
    <safetyreportid>4521778-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_040603415</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2 OTHER</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040413</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUVOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER (FAMOTIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARAPLATIN(CARBOPLATIN SANOFI-SYNTHELABO)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521779-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-16</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>70231</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPIOID NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521780-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-15</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>70231</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521781-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8006925</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE DRUG EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>750 MG/D</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>1 G/D</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521782-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101103</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY TRAUMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAVERJECT IMPULSE DUAL CAMBER SYSTEM POWDER, STERILE (ALPROSTADIL)</medicinalproduct>
        <drugbatchnumb>54250A92</drugbatchnumb>
        <drugauthorizationnumb>21212</drugauthorizationnumb>
        <drugdosagetext>20 MCG (20 MCG, PRN</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521783-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-14</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>70231</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521784-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8008184</companynumb>
    <primarysource>
      <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>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>1000 MG/ D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>1000 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521785-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-21</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>70231</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID (LONG-ACTING) (VALPROIC ACID)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521786-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.2658</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>1 PER DAY</drugdosagetext>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WEAR WRIST AND ARM BRACES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521787-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096631</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.5547</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugbatchnumb>546011321</drugbatchnumb>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM (MINERALS NOS, VITAMINS NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521788-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.8957</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE   20MG    GENERIC</medicinalproduct>
        <drugdosagetext>      ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext> ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>5-HTP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALARIAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ST. JOHN'S WORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521789-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.4003</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521790-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED ACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXICET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521791-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041183786</companynumb>
    <primarysource>
      <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>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>7RT26M</drugbatchnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILETIN-BEEF/PORK REGULAR INSULIN (INSULIN, ANIMAL)</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENTE ILETIN (BEEF-PORK) INSULIN ZINC</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPH ILETIN I (BEEF-PORK)</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521792-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.4932</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>250 MG  DAILY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521793-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184194</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE ALLERGIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEASONAL ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE KETONE BODY PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>7RK21M</drugbatchnumb>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>8 U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>7SG68M</drugbatchnumb>
        <drugdosagetext>14 U/1 IN THE MORNING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>7RL30M</drugbatchnumb>
        <drugdosagetext>14 U/1 IN THE MORNING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521794-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101388</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALDECOXIB</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521795-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-18</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>70231</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521796-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004091375</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>ONE HALF AS NEEDED, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
        <drugdosagetext>1000 MCG (500 MCG, 2 IN 1</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521797-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-17</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>70231</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521798-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040978509</companynumb>
    <primarysource>
      <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>ABDOMINAL REBOUND TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG DAY</drugdosagetext>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521799-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-22</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>70231</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521800-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0407104266</companynumb>
    <primarysource>
      <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>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH IMPACTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>30 MG/D</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILAFON (PERPHENAZINE ENANTATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521801-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-10</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugauthorizationnumb>72410</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521802-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07403-44</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugauthorizationnumb>40009</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521803-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041200654</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>18.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTICATION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRMATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521804-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041200900</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109.77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENITAL DISORDER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521805-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041200912</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.38</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>NEUROPATHIC PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPOROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521806-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041201075</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102.06</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>500 MG/AM  500 MG/PM</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521807-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-RB-988-2004</companynumb>
    <primarysource>
      <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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020325</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521808-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105220</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
        <drugindication>PYREXIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521809-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414531FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAFORAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMPERAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BURINEX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIFLOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SURBRONC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EUPRESSYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521810-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419260US</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL NATRIURETIC PEPTIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN (NOS)</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</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>COMBIVENT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521811-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040325</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200411265FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL THROMBOSIS LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD FIBRINOGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN D DIMER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOCET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIHYDROERGOTAMINE MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PINEALOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521812-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413497JP</companynumb>
    <primarysource>
      <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>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF MATERNAL EXPOSURE TO THERAPEUTIC DRUGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRE-ECLAMPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN (INSULIN PUMP)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521813-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040319</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410610DE</companynumb>
    <primarysource>
      <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>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIASTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521814-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041200936</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>15-20 MG/DAILY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521815-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-07427-01</companynumb>
    <primarysource>
      <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>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</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>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG QD</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugdosagetext>800 IU TID</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521816-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugdosagetext>600 MG   BID   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>80 MG   QD   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521817-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040904513</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE PRERENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN IB</medicinalproduct>
        <drugauthorizationnumb>19012</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2 IN 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIBRAMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521818-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1000 MG   INTRAVENOU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOCARDITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1000 MG   INTRAVENOU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041218</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521819-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-07139-01</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>5 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>15 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>10 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT (DONEPEZIL HYIDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRENTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521820-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NARCOLEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YAWNING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>150MG  ONCE DAILY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521821-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-NOVOPROD-240866</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN GE NPH</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN GE TORONTO</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL ^ACHE^</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATERAX</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REACTINE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521822-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041106618</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ASPERGER'S DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOURETTE'S DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521823-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041200215</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEPRONIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEPRONIZINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MODECATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFATER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFATER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFATER</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521824-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20041201145</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE DIASTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugdosagetext>DOSE TAKEN AT ONE TIME</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521825-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-04389-01</companynumb>
    <primarysource>
      <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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>5 MG QOD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLENDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521826-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8008131</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>35.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BELLIGERENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD BANGING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEGATIVISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>250 MG 1/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIVALPROEX SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARNITINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMAN INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>..</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521827-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>T04-USA-07614-01</companynumb>
    <primarysource>
      <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>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE (OPEN LABEL, PHASE D) (MEMANTINE)</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE (OPEN LABEL, PHASE C) (MEMANTINE)</medicinalproduct>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE (OPEN LABEL, PHASE B) (MEMANTINE)</medicinalproduct>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE (DOUBLE BLIND, PHASE A) (MEMANTINE)</medicinalproduct>
        <drugdosagetext>2 TABLET BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020708</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERTHROMYCIN 2% (ERYTHROMYCIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521828-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2004-0017852</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugauthorizationnumb>21044</drugauthorizationnumb>
        <drugdosagetext>MG, Q3H, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521829-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004EU002106</companynumb>
    <primarysource>
      <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>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA INFECTIOSUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUPRED (PREDNISOLONE SODIUM SULFOBENZOATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521830-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-12783403</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521831-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12782678</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>BONE MARROW TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugindication>BONE MARROW TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARMUSTINE</medicinalproduct>
        <drugindication>BONE MARROW TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARA-C</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEM CELL TRANSPLANTATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521832-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12782470</companynumb>
    <primarysource>
      <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>IDIOPATHIC PNEUMONIA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE NODULAR SCLEROSIS STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE NODULAR SCLEROSIS STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE NODULAR SCLEROSIS STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>AUTOLOGOUS BONE MARROW TRANSPLANTATION THERAPY</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>AUTOLOGOUS BONE MARROW TRANSPLANTATION THERAPY</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARMUSTINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>AUTOLOGOUS BONE MARROW TRANSPLANTATION THERAPY</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE NODULAR SCLEROSIS STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARA-C</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE NODULAR SCLEROSIS STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE NODULAR SCLEROSIS STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEM CELL TRANSPLANTATION</medicinalproduct>
        <drugindication>HODGKIN'S DISEASE NODULAR SCLEROSIS STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugindication>HODGKIN'S DISEASE NODULAR SCLEROSIS STAGE UNSPECIFIED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521833-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12782553</companynumb>
    <primarysource>
      <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>IDIOPATHIC PNEUMONIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>AUTOLOGOUS BONE MARROW TRANSPLANTATION THERAPY</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>AUTOLOGOUS BONE MARROW TRANSPLANTATION THERAPY</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARMUSTINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>AUTOLOGOUS BONE MARROW TRANSPLANTATION THERAPY</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARA-C</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEM CELL TRANSPLANTATION</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugdosagetext>CGY</drugdosagetext>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521834-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041201291</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521835-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004US001454</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.9</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL (ENALAPRIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521836-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040816</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040805278</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIADUR</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521837-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQ8050305NOV2001</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.17</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>16 MG ONE TIME PER ONE DOSE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLECAINIDE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM (MEROPENEM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THROMBIN LOCAL SOLUTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521838-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041200890</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEMORAL NECK FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELMIRON</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CYSTITIS INTERSTITIAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521839-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041104195</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAELYX</medicinalproduct>
        <drugdosagetext>40 MG X2 CYCLES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERGENTAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521840-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041008038</companynumb>
    <primarysource>
      <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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK SECOND DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugdosagetext>36MG+18MG SO DOSAGE COULD BE ADJUSTED AT HOME AS NEEDED.</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521841-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8008205</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>1000 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521842-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12781159</companynumb>
    <primarysource>
      <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 INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SECTRAL</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521843-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12782587</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugbatchnumb>03C00444B</drugbatchnumb>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>REC'D ABOUT 15 MINS. PRIOR TO CETUXIMAB</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521844-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004EU002097</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANTED LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS GRANULOMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTOPLASMOSIS DISSEMINATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugindication>TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugindication>TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521845-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041200320</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521846-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041106417</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TERMINAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>25 MG TO 50 MG PER DAY, AS NEEDED</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521847-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041201242</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORCET-HD</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORCET-HD</medicinalproduct>
        <drugdosagetext>10/650</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521848-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041201605</companynumb>
    <primarysource>
      <qualification>2</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521849-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041201638</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0416525</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521850-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041003801</companynumb>
    <primarysource>
      <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>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521851-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQ5394119NOV2002</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA FUNGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOOCCLUSIVE LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021016</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521852-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108551</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>BIPOLAR I DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521853-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQ0473704FEB2002</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM TREMENS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIMETAPP</medicinalproduct>
        <drugauthorizationnumb>12436</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIMETAPP</medicinalproduct>
        <drugauthorizationnumb>12436</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIMETAPP</medicinalproduct>
        <drugauthorizationnumb>12436</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKA-SELTZER PLUS COLD (ACETYLSALICYLIC ACID/CHLORPHENAMINE MALEATE/PH</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKA-SELTZER PLUS COLD (ACETYLSALICYLIC ACID/CHLORPHENAMINE MALEATE/PH</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKA-SELTZER PLUS COLD (ACETYLSALICYLIC ACID/CHLORPHENAMINE MALEATE/PH</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROBITUSSIN CF (GUAIFENESIN/DEXTROMETHORPHAN/PHENYLPROPANOLAMINE, SYRUP</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINE-OFF N.D. (PARACETAMOL/PHENYLPROPANOLAMINE HYDROCHLORIDE, )</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINE-OFF N.D. (PARACETAMOL/PHENYLPROPANOLAMINE HYDROCHLORIDE, )</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINE-OFF N.D. (PARACETAMOL/PHENYLPROPANOLAMINE HYDROCHLORIDE, )</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVIST D (CLEMASTINE FUMARATE/PHENYLPROPANOLAMINE HYDROCHLORIDE, )</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIAMINIC (CHLORPHENAMINE MALEATE/PHENYLPROPANOLAMINE HYDROCHLORIDE, S</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIAMINIC (CHLORPHENAMINE MALEATE/PHENYLPROPANOLAMINE HYDROCHLORIDE, S</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIAMINIC (CHLORPHENAMINE MALEATE/PHENYLPROPANOLAMINE HYDROCHLORIDE, S</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521854-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004EU002087</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20.00 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYOSTACINE (PRISTINAMYCIN) TABLET, 500MG</medicinalproduct>
        <drugdosagetext>1.00 G, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN (FLUINDIONE) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521855-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004090054</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RUPTURED CEREBRAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>25 MG (25 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>1200 MG (300 MG, 2 IN 2 D)</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugdosagetext>80 MG (40 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE (CLONIDIINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521856-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041004794</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</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>FAECES HARD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTAT (ROXATIDINE ACETATE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN (MOSAPRIDE CITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521857-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8008123</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>95</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>250 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENTAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>500 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENTAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521858-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099560</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50.8029</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLTERODINE L-TARTRATE CAPSULE, PROLONGED RELEASE (TOLTERODINE L-TARTR</medicinalproduct>
        <drugbatchnumb>C400016</drugbatchnumb>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>2 MG (2 MG, QD INTERVAL: EVERY DAY) ORAL;  MG (4 MG, QD INTERVAL: EVERY DAY) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLTERODINE L-TARTRATE CAPSULE, PROLONGED RELEASE (TOLTERODINE L-TARTR</medicinalproduct>
        <drugbatchnumb>C400016</drugbatchnumb>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>2 MG (2 MG, QD INTERVAL: EVERY DAY) ORAL;  MG (4 MG, QD INTERVAL: EVERY DAY) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMODIUM (LOPERAMIDE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521859-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-1227780-NL</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>125.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugauthorizationnumb>20415</drugauthorizationnumb>
        <drugdosagetext>7.5 MG QD, ORAL TOTAL 2 DOSES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARAGORIC TINCTURE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521860-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-122401-NL</companynumb>
    <primarysource>
      <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>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugauthorizationnumb>20415</drugauthorizationnumb>
        <drugdosagetext>15 MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521861-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_040904506</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE SUBCUTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugbatchnumb>E0839CA</drugbatchnumb>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHINESE MEDICINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521862-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_81151_2004</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.8957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugauthorizationnumb>21196</drugauthorizationnumb>
        <drugdosagetext>15 G NIGHTLY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CATAPLEXY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugauthorizationnumb>21196</drugauthorizationnumb>
        <drugdosagetext>15 G NIGHTLY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NARCOLEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>15 MG NIGHTLY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521863-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBS041115951</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT (NIFEDIPINE PA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFUROXIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521864-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-0007780</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA NEONATAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE (TENOFOVIR DISOPROXIL FUMARATE)</medicinalproduct>
        <drugauthorizationnumb>21356</drugauthorizationnumb>
        <drugdosagetext>600 MG, ONCE</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PCN (BENZYLPENICILIN SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521865-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004US001360</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTOPIC</medicinalproduct>
        <drugauthorizationnumb>50777</drugauthorizationnumb>
        <drugdosagetext>TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAMIDINE (PENTAMIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM (MEROPENEM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521866-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-0007677</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>2.8</patientweight>
      <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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA NEONATAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE (TENOFOVIR DISOPROXIL FUMARATE)</medicinalproduct>
        <drugauthorizationnumb>21356</drugauthorizationnumb>
        <drugdosagetext>600 MG, 1 IN 1 ONCE</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZT</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYTONADIONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521867-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04120002</companynumb>
    <primarysource>
      <qualification>1</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>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521868-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-06202-01</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108.4097</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</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>20040226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040903</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521869-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12779609</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATATONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521870-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-07587-01</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</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>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521871-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12752762</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>112</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>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugindication>LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521872-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004US16186</companynumb>
    <primarysource>
      <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>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521873-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB03974</companynumb>
    <primarysource>
      <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>FULL BLOOD COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REGURGITATION OF FOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>350MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001206</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521874-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-USA-07822-01</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521875-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04210</companynumb>
    <primarysource>
      <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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QRS AXIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCINE HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>300UG/DAY</drugdosagetext>
        <drugindication>SALIVARY HYPERSECRETION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>500UG/DAY</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
        <drugtreatmentduration>116</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>275MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
        <drugtreatmentduration>15840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521876-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-07582-01</companynumb>
    <primarysource>
      <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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060216</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521877-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040808132</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DEPRESSED MOOD</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>MALAISE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521878-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>0410026</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>0.4536</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORFADIN</medicinalproduct>
        <drugbatchnumb>1697168</drugbatchnumb>
        <drugauthorizationnumb>21232</drugauthorizationnumb>
        <drugdosagetext>2 MILLIGRAM TWICE DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYROSINAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521879-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SYMT20040004</companynumb>
    <primarysource>
      <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>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMMETREL</medicinalproduct>
        <drugauthorizationnumb>18101</drugauthorizationnumb>
        <drugdosagetext>500 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521880-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004.1547</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.0906</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugauthorizationnumb>76192</drugauthorizationnumb>
        <drugdosagetext>150MCG Q WK SUBCUTANEOU</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>1200 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL TABLETS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521881-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2004-0017483</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>114.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL CHEST SOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</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 GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBIN BLOOD INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYSUBSTANCE ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHONCHI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugdosagetext>100 MG, BID,</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE (MORPHINE) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL/HCTZ 2.5/6.25 (HYDROCHLOROTHIAZIDE, METOPROLOL TARTRATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521882-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugbatchnumb>126307</drugbatchnumb>
        <drugdosagetext>5 MG PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL 5 MG EON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521883-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>100 MGM BID</drugdosagetext>
        <drugindication>POLYCYSTIC OVARIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521884-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.173</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BCNU 80MG/M2</medicinalproduct>
        <drugdosagetext>170 MG, IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ASTROCYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521885-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugdosagetext>10/20 DAILY-ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLENDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEMCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521886-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-122673-NL</companynumb>
    <primarysource></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 DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVIX CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>MENSTRUAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>MENSTRUATION IRREGULAR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521887-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CEL-2004-01869-ROC</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXTROMETHORPHAN HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>18658</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521888-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097759</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER IN SITU</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521889-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.05</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>318 MG IV Q2WKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>168 MG IV Q2WKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVSIN PB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521890-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HORMONE LEVEL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTEST H.S.</medicinalproduct>
        <drugdosagetext>1 TAB - 1 X DAY ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521891-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098202</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521892-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <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>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>1   3 TIMES PER DA</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>1   3 TIMES PER DA</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>1   3 TIMES PER DA</drugdosagetext>
        <drugindication>NERVOUSNESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521893-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BDI-006711</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOVUE-370</medicinalproduct>
        <drugbatchnumb>4D50146</drugbatchnumb>
        <drugauthorizationnumb>18735</drugauthorizationnumb>
        <drugdosagetext>110 ML ONCE IC</drugdosagetext>
        <drugindication>CATHETERISATION CARDIAC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521894-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DL2004300</companynumb>
    <primarysource>
      <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 COMPLETE COMPLICATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521895-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2004-0017808</companynumb>
    <primarysource>
      <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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521896-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004091361</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94.3482</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521897-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004241294US</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.2147</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, ONCE DAILY)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521898-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RELPAX</medicinalproduct>
        <drugdosagetext>40 MG % PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040505</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521899-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004091425</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521900-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098207</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN HYDROCHLORIDE (EPIRUBICIN HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>50778</drugauthorizationnumb>
        <drugdosagetext>150 MG, EVERY 21 DAYS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL (DOCETAXEL)</medicinalproduct>
        <drugdosagetext>150 MG , EVERY 21 DAYS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1000 MG, EVERY 21 DAYS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE EDISYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON (GRANISETRON)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA (DARBEPOETIN ALFA)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521901-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030924</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-12392221</companynumb>
    <primarysource>
      <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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>CY. 2 ON 06-JUN = 125 MG (DUE TO WT. LOSS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>2ND CYCLE (06-JUN) - 275 MG (DUE TO WT. LOSS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030527</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521902-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2003BR01504</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRAMIL</medicinalproduct>
        <drugdosagetext>1 TABLET/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521903-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12782579</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOAMING AT MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugbatchnumb>03C00444B</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </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>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521904-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12781373</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521905-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CA16114</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIORIDAZINE HCL</medicinalproduct>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521906-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004091437</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.5244</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
        <drugindication>ORAL MUCOSAL BLISTERING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DRUG, UNSPECIFIED (DRUG, UNSPECIFIED)</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521907-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRANIOSYNOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugdosagetext>1        4     ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020311</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521908-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.5547</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>TWICE DAILY FOR 5 DAYS</drugdosagetext>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521909-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04429</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOREA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030408</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521910-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101460</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.2554</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMPERAZOLE (ESCOMPERAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE (MEGESTEROL ACETATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM (ESCITALOPRAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBEIN (ZOLPIDEM TARTRATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521911-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2003BR01503</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOARSENESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugdosagetext>50 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugtreatmentduration>152</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugdosagetext>400 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPLICTIL</medicinalproduct>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugtreatmentduration>152</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521912-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12782603</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugbatchnumb>03C00444A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521913-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004242959US</companynumb>
    <primarysource>
      <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>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH INJECTABLE CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugbatchnumb>01JWJ</drugbatchnumb>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>150 MG (150 MG, SINGLE INJECTION), INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040813</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521914-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT RESPULES</medicinalproduct>
        <drugdosagetext>0.5 MG BY NEBULIZER</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT RESPULES</medicinalproduct>
        <drugdosagetext>0.5 MG BY NEBULIZER</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTEX PSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAXIN XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521915-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.1637</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLUE TOE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HORNER'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOESTRIN FE 1/20</medicinalproduct>
        <drugdosagetext>1 TAB PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521916-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>135.1719</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugdosagetext>1.4 ML/WK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLTX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521917-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100179</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLTERODINE LA (TOLTERODINE)</medicinalproduct>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521918-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.6683</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOUS MEMBRANE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>SEE SECTION B5</drugdosagetext>
        <drugindication>HOT FLUSH</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>SEE SECTION B5</drugdosagetext>
        <drugindication>MENOPAUSE</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521919-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100116</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <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>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROPIPATE</medicinalproduct>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521920-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugdosagetext>800MG (2X400MG) ONCE/DAY</drugdosagetext>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZMACORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521921-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORRECTOL</medicinalproduct>
        <drugbatchnumb>3NO4PE</drugbatchnumb>
        <drugdosagetext>2 TABS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LAXATIVE SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALESSE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521922-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099200</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.2554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HYDROCHLORIDE CAPSULE (CLINDAMYCIN HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>50162</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521923-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004094498</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <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>ESTRADIOL</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATEST H.S.</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521924-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101425</companynumb>
    <primarysource></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>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521925-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097718</companynumb>
    <primarysource></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>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521926-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE240830NOV04</companynumb>
    <primarysource>
      <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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE MB INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521927-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US101644</companynumb>
    <primarysource>
      <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>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PARATHYROID HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL AND PANCREAS TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521928-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040812</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US086933</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTI-ERYTHROPOIETIN ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521929-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US098658</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BIOPSY BONE MARROW ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521930-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097433</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19900101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19880101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESTROGEN REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROGESTIN REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521931-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004084536</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIVERT</medicinalproduct>
        <drugauthorizationnumb>10721</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDIAC THERAPY (CARDIAC THERAPY)</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521932-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097045</companynumb>
    <primarysource>
      <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>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>80 MG (40 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521933-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004085808</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.2554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF PRESSURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>100 MG (100 MG, AS NECESSARY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABUMETONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE VITAMINS (ASCORBIC AICD, ERGOCALCIFEROL, FOLIC ACID, RETINOL,</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521934-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096880</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.9885</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>2.5 MG (2.5 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugdosagetext>10 MG (1O MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL (CANDESARTAN CILEXETIL)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE (BUDESONIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521935-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099298</companynumb>
    <primarysource>
      <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>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>80 MG (40 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIMETCONE, ACTIVATED (SIMETICONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521936-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEPROSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521937-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040907</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-12693727</companynumb>
    <primarysource>
      <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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>15MG 07-MAR-04 TO 11-JUL-04, 30MG 12-JUL-04 TO 26-JUL-04 (INTERRUPTED).</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
        <drugtreatmentduration>142</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugindication>AGGRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521938-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-00388</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44.4</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>WB004A1</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>WB004A1</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040823</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521939-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12763652</companynumb>
    <primarysource>
      <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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521940-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099150</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG, DECREASED FROM 3 TO 2 TIMES A DAY</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521941-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>110.6777</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>375MG  PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521942-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20001124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZONI002068</companynumb>
    <primarysource>
      <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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521943-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521944-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>ONCE A DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521945-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEVA GENERIC FOR NEURONTIN 400MG</medicinalproduct>
        <drugdosagetext>THREE TIMES A DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521946-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.8122</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugbatchnumb>4-BBS-507</drugbatchnumb>
        <drugdosagetext>2 PUFFS 2 TO 4X/DAY PRN</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521947-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46.7205</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>6 ML BY MOUTH TWICE/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRO-K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OYSTER SHELL CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521948-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040979034</companynumb>
    <primarysource>
      <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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521949-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041082115</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF4C01C</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM PLUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521950-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.3597</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARVON COMPOUND-65</medicinalproduct>
        <drugdosagetext>2 A DAY</drugdosagetext>
        <drugindication>MYALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521951-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041081174</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZMACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521952-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099159</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040420</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521953-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004091430</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.3388</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (VITAMINS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521954-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004071904</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RELPAX</medicinalproduct>
        <drugauthorizationnumb>21016</drugauthorizationnumb>
        <drugdosagetext>40 MG (40 MG, 1 IN 1 AS NECESSARY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugdosagetext>0.25 MG (0.25 MG, 2 IN 1 WK), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PITUITARY TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521955-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>136.0791</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGOMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPRINTEC</medicinalproduct>
        <drugbatchnumb>290164001</drugbatchnumb>
        <drugdosagetext>1 TABLER   ONCE DAILY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521956-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041081646</companynumb>
    <primarysource>
      <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>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521957-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040977936</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF3Z39A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>...</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521958-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097591</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LARYNGEAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
        <drugauthorizationnumb>18422</drugauthorizationnumb>
        <drugdosagetext>(1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521959-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098455</companynumb>
    <primarysource>
      <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>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>20090</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG,1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSCYSTEINE (ACETYLSCYSTEINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APOREX (DEXTROPROPOXYPHENE HYDROCHLORIDE, PARACETAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521960-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004208369FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE IMMEASURABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN PHOSPHATE</medicinalproduct>
        <drugauthorizationnumb>50441</drugauthorizationnumb>
        <drugdosagetext>600 MG (1 IN 1 TOTAL), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUXAMETHONIUM CHLORIDE (SUXAMETHONIUM CHLORIDE)</medicinalproduct>
        <drugdosagetext>70 MG ( 1 IN 1 TOTAL), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUFENTANIL CITRATE</medicinalproduct>
        <drugdosagetext>15 MCG (1 IN 1 TOTAL), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521961-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004082916</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRACHIAL PLEXUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL RIB EXCISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20882</drugauthorizationnumb>
        <drugdosagetext>2400 MG (1200 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHIC PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521962-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-240863</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>0</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>6.9 MG, UNK</drugdosagetext>
        <drugindication>GASTROINTESTINAL HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>6.9 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521963-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004082506</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521964-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004074540</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
        <drugauthorizationnumb>19885</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040526</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521965-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004093082</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH SCALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DESQUAMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521966-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098221</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>(10 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521967-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097460</companynumb>
    <primarysource></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>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521968-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097737</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FELDENE</medicinalproduct>
        <drugauthorizationnumb>18147</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELIPROLOL (CELIPROLOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521969-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097559</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALDECOXIB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521970-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004232473US</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>21131</drugauthorizationnumb>
        <drugdosagetext>1200 MG (600 MG, TWICE DAILY), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLYCOPEPTIDE ANTIBIOTIC RESISTANT ENTEROCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZTREONAM (AZTREONAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN-FRACTION, SODIUM SALT (HEPARIN-FRACTION, SODIUM SALT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEBENDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521971-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>15MG  AM ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521972-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.2554</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521973-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>ANTIPSYCHOTIC DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM  450MG</medicinalproduct>
        <drugdosagetext>450MG  AMHS  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521974-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004078428</companynumb>
    <primarysource></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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES (ANTIHYPERTENSIVES)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521976-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098230</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521977-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>4.536</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD HOMOCYSTEINE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL COORDINATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE AMINO ACID LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugbatchnumb>070026W</drugbatchnumb>
        <drugdosagetext>1/2 PKT  DAILY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugbatchnumb>070026W</drugbatchnumb>
        <drugdosagetext>1/2 PKT  DAILY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHLORHYDRIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040207</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521978-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098226</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521979-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.1939</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST WALL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10  DAILY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521980-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.4514</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>1 CAPSULE  EVERY DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521981-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098262</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.0604</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521982-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPOSIT EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE  200MG  WYETH LABS</medicinalproduct>
        <drugdosagetext>200MG  DAILY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE  200MG  WYETH LABS</medicinalproduct>
        <drugdosagetext>200MG  DAILY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040508</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521983-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098236</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MICROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN (ROSUVASTATIN)</medicinalproduct>
        <drugdosagetext>20 MG (1 IN 1 D)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL (ENALAPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALSALATE (SALSALATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE (VENLAFAXINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521984-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004093935</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.5244</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIMBITROL (AMITRIPTYLINE HYDROCHLORIDE, CHLORDIAZEPOXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THERAGRAN (VITAMINS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELLADENAL (BELLADONNA EXTRACT, PHENOBARBITAL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521985-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415500BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE ALLERGIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>276553L</drugbatchnumb>
        <drugdosagetext>325 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521986-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004093550</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521987-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415733BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.2658</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORIGINAL ALKA-SELTZER TABLETS</medicinalproduct>
        <drugbatchnumb>A3K20A</drugbatchnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521988-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004234934US</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECONOMIC PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521989-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24015</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.11</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521990-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24401</companynumb>
    <primarysource></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>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521991-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-000828</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OVCON 50 28 DAY TREATMENT (ETHINYLESTRADIOL, NORETHINDRONE) TABLET,  5</medicinalproduct>
        <drugauthorizationnumb>17576</drugauthorizationnumb>
        <drugdosagetext>50/1000UG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METRORRHAGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521992-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004213091US</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NOSOCOMIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>20571</drugauthorizationnumb>
        <drugdosagetext>100 MG/M*2 (100 MG/M*2, CYCLIC), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE (GEMCITABINE HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>1000 MG/M2*2 (1000 MG/M2*2, CYCLIC), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040324</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521993-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24228</companynumb>
    <primarysource>
      <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>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521994-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096408</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>ROTATOR CUFF SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521995-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040669271</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF4D73A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS CONJUGATED W/ MEDROXYPROGESTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE W/VITAMIN D NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSTAIN-TEARS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONE MINERAL DENSITY/Z</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONE MINERAL DENSITY/T</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONE MINERAL DENSITY/Z</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521996-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW23884</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521997-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>188844</companynumb>
    <primarysource>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P30010</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P30010</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521998-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040465197</companynumb>
    <primarysource>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BURNING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FUSION SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGICAL PROCEDURE REPEATED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF2BL7A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG/1 DAY</drugdosagetext>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
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        <drugenddate>20040806</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4521999-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040463795</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM PLUS D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522000-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA030127542</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE JOINT PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF1V19A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRASE (PANCRELIPASE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522001-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>196155</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.7507</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ELECTROLYTES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</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>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBINAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522002-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040978553</companynumb>
    <primarysource>
      <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 CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR (MONTELUKAST)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT (IPRATROPIUIM BROMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRATESTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIFED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXATIVE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522003-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2004AU01433</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTPARTUM HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTOCINON</medicinalproduct>
        <drugbatchnumb>S06100</drugbatchnumb>
        <drugdosagetext>5 IU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTOCINON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522004-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>20041100491</companynumb>
    <primarysource></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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPIATES POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugauthorizationnumb>83312</drugauthorizationnumb>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugdosagetext>1 OTHER PT</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN (ACETAMINOPHEN AND HYDROCODONE BITARTRATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522005-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>100 MG ONCE INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522006-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRIDOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFOTETAN 1 GRAM</medicinalproduct>
        <drugdosagetext>1 GRAM BID INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040822</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522007-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096963</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102.0593</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugdosagetext>5 MG (5 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL IMPAIRMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN (TERAZOSIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522008-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEFINITY</medicinalproduct>
        <drugindication>ECHOCARDIOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAG OX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KCL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT NASAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNISOLIDE NASAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRETINOIN CREAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APAP TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT B12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELECT PROTOCOL MEDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522009-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098307</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522010-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04136</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugdosagetext>10 ML, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-DYDRAMOL</medicinalproduct>
        <drugdosagetext>2 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugdosagetext>50 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522011-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</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>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>3 MG/1.5 MG  MON/REST ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCOAGULATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APAP TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE/ZIDOVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522012-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>197944</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.4514</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECONOMIC PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <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>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE W/ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522013-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>204802</companynumb>
    <primarysource></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>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522014-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.3993</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>80 MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522015-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIMETAPP</medicinalproduct>
        <drugdosagetext>ONCE ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT CONGESTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041205</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522016-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>204817</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</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>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P30077</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040225</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522017-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugdosagetext>1000MG  AMHS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522018-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXCARBAZEPINE  600MG</medicinalproduct>
        <drugdosagetext>600MG  QID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522019-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12594</companynumb>
    <primarysource>
      <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>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISUDYNE</medicinalproduct>
        <drugauthorizationnumb>21119</drugauthorizationnumb>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522020-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040978094</companynumb>
    <primarysource>
      <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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG/11 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040531</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522021-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040419</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-236439</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMARTHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTRENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>100 UG/KG, SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMOPHILIA A WITH ANTI FACTOR VIII</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>100 UG/KG, SINGLE DOSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>100 UG/KG  3 HOURS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>100 UG/KG, EVERY 3 HOURS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>100 UG/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>100 UG/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>100 UG/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>100 UG/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>100 UG/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>100 UG/KG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugdosagetext>6 TAB, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASCON</medicinalproduct>
        <drugdosagetext>6 TAB, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040129</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELEMINSOFT</medicinalproduct>
        <drugdosagetext>120 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040130</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522022-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0405103177</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL STRANGULATED HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL WALL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL STOMA COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>750 UG</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040212</drugstartdate>
      </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>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLENDIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522023-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041080416</companynumb>
    <primarysource>
      <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>DIVERTICULAR PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522024-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0407104280</companynumb>
    <primarysource>
      <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>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040604</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522025-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040259937</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF3Z81C</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAPINE (DIAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522026-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>201857</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANT SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</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>20020901</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>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522027-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA031255281</companynumb>
    <primarysource>
      <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>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIUS FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF3X85A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522028-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>203182</companynumb>
    <primarysource></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>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE ER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </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>4522029-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>203409</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</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>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522030-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>204387</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.318</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH 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>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522031-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041106512</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILE DUCT STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040530</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040530</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040530</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>INJECTION</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>INJECTION</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROTIZOLAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOTONIC SODIUM CHLORIDE SOLUTION</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOTONIC SODIUM CHLORIDE SOLUTION</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOTONIC SODIUM CHLORIDE SOLUTION</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOTONIC SODIUM CHLORIDE SOLUTION</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOTONIC SODIUM CHLORIDE SOLUTION</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENSURE LIQUID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENSURE LIQUID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENSURE LIQUID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE ACETATED RINGERS SOLUTION</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE ACETATED RINGERS SOLUTION</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE ACETATED RINGERS SOLUTION</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE ACETATED RINGERS SOLUTION</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE ACETATED RINGERS SOLUTION</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN AXETIL</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN AXETIL</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN AXETIL</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN AXETIL</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMEDIN</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMEDIN</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMEDIN</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCAINE HYDROCHLORIDE INJ</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINO ACID INJ</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC SULFATE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTATED RINGER'S</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTATED RINGER'S</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTATED RINGER'S</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAZOCINE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522032-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184372</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF4M78B</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522033-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>206848</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST 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>20000204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522034-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207015</companynumb>
    <primarysource>
      <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>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INNER EAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</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>19981201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522035-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184257</companynumb>
    <primarysource></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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MECHANICAL COMPLICATION OF IMPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF4L56A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522036-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040511</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>701975</companynumb>
    <primarysource>
      <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>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIALOADENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMEVIVE</medicinalproduct>
        <drugdosagetext>15 MG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL PILL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPICAL STEROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522037-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184123</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522038-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184059</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>38</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMYELINATING POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF3M22A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROBID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522039-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12775029</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>112</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522040-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184057</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT RANGE OF MOTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF4L04A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE CHONDROITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENIUM TRACE METAL ADDITIVE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIDOPHILUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUTEIN</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>BILBERRY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522041-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12770129</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugbatchnumb>010216</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522042-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12709762</companynumb>
    <primarysource>
      <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>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURKITT'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE BONE MARROW APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCHOLECYSTIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOPHOS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BURKITT'S LYMPHOMA STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040426</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARACYTINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BURKITT'S LYMPHOMA STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040426</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522043-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12779997</companynumb>
    <primarysource>
      <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>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LERCANIDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522044-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184608</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>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522045-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12784161</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>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT RELATED SECONDARY MALIGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEPESID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
        <drugtreatmentduration>158</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021019</drugenddate>
        <drugtreatmentduration>145</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021001</drugenddate>
        <drugtreatmentduration>232</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANDA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020903</drugenddate>
        <drugtreatmentduration>252</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIACIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020418</drugenddate>
        <drugtreatmentduration>113</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THERARUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020905</drugenddate>
        <drugtreatmentduration>73</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522046-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041200341</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>BENIDIPINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINO ACID PREPARATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PARENTERAL NUTRITION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522047-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041200640</companynumb>
    <primarysource>
      <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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANIDIPINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILAZAPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZELASTINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522048-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041007329</companynumb>
    <primarysource>
      <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>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ASPERGILLOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522049-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA031050251</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE WITH MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WOODWARDS GRIPE WATER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMETROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522050-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA031050084</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ABNORMALITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG/1 AT BEDTIME</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522051-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-MERCK-0411POL00009</companynumb>
    <primarysource>
      <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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>198</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>1328</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>198</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522052-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020905</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0209USA00468</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSPASM CORONARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EROSIVE OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIUM AVIUM COMPLEX INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS EXTERNA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CAVITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MORBILLIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH VESICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE TANNATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMPRENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINORIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522053-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00477</companynumb>
    <primarysource>
      <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>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522054-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030923</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0309USA02507</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTMENOPAUSAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991011</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522055-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00752</companynumb>
    <primarysource>
      <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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000418</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522056-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0301USA03167</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA OF CHRONIC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BETA HAEMOLYTIC STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ERYTHROPOIETIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS EROSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCOAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISIONAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INGUINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PICKWICKIAN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE FEVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991213</drugenddate>
        <drugtreatmentduration>347</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522057-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098775</companynumb>
    <primarysource>
      <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>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugauthorizationnumb>9866</drugauthorizationnumb>
        <drugdosagetext>TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugdosagetext>TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
        <drugdosagetext>OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522058-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098558</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>25 MG (20 MG/ML, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSTHYMIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040712</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522059-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098497</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL (ETHANOL)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522060-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0412FRA00017</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>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE VALERATE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522061-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00902</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522062-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20021015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0210USA01631</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADJUSTMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCHROMIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL VENOUS SINUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER MOTOR NEURONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DERMATOMYOSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DERMATOMYOSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRELONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DERMATOMYOSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRELONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MENSTRUATION IRREGULAR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020223</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONAL CONTRACEPTIVES (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522063-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004080726</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ELECTROLYTES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD FIBRINOGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN DEGRADATION PRODUCTS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANT SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARROW HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PACEMAKER COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
        <drugauthorizationnumb>19885</drugauthorizationnumb>
        <drugdosagetext>20 MG (10 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDENALIN (DOXAZOSIN)</medicinalproduct>
        <drugdosagetext>2 MG (1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GALENIC /PANIPENEM/BETAMIPRON/ (BETAMIPRON, PANIPENEM)</medicinalproduct>
        <drugdosagetext>1 GRAM (1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1 GRAM  (1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>200 MG (100 MG, 2 IN 1)</drugdosagetext>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLDOPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL (NICORANDIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHERYL NICOTINATE (TOCOPHERYL NICOTINATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA LEAF (SENNA LEAF)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CABDESARTAB CILEXETIL (CANDESARTAN CILEXETIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOGLIOBOSE (VOGLIOBOSE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522064-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03578</companynumb>
    <primarysource>
      <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>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVANZ</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522065-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0410CAN00030</companynumb>
    <primarysource>
      <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>GASTRIC OUTLET OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522066-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00524</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENPROCOUMON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522067-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00391</companynumb>
    <primarysource>
      <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>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031020</drugenddate>
        <drugtreatmentduration>700</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522068-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0408USA02352</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522069-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040227</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0402USA02038</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011203</drugenddate>
        <drugtreatmentduration>73</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXICET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030111</drugenddate>
        <drugtreatmentduration>799</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522070-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA02784</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
        <drugtreatmentduration>1081</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522071-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00471</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERY DISSECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTEBRAL ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTEBRAL ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040404</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040330</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522072-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098610</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLINERGIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERNATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE (SERTRALINE)</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>300 MG (100 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>5 MG ( 5 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCYCLIDINE HYDROCHLORIDE (PROCYCLIDINE HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>15 MG ( 5 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORMETAZEPAM (LORMETAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL (ACENCOCOUMAROL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522073-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-MERCK-0411CHE00029</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>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CERVICAL ROOT PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522074-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2002065173</companynumb>
    <primarysource>
      <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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugauthorizationnumb>18422</drugauthorizationnumb>
        <drugdosagetext>1200 MG (BID)</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROXITHROMYCIN (ROXITHROMYCIN)</medicinalproduct>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>80 MG (QD)</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522075-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003159050DE</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>3 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522076-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00778</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000323</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522077-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AMGEN-US097015</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLAST CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHROMELALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD CELLS, PACKED HUMAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522078-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031219</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0312USA02227</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO POSITIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020701</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE + D</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522079-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0412AUS00032</companynumb>
    <primarysource></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>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522080-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004081481</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>10 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522081-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-MERCK-0412CHE00007</companynumb>
    <primarysource>
      <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 PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522082-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00051</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522083-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-MERCK-0412ITA00008</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RUTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELILOT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522084-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-MERCK-0412SWE00006</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
        <drugtreatmentduration>421</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522085-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00086</companynumb>
    <primarysource>
      <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>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPERATIVE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEVETEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522086-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00004</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522087-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-MERCK-0412SWE00007</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN AND DIPYRIDAMOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TRANSIENT ISCHAEMIC ATTACK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522088-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00090</companynumb>
    <primarysource>
      <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>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522089-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-MERCK-0412NOR00009</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMATROPIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD GROWTH HORMONE ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522090-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0412CAN00034</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TINNITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522091-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00195</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSECUTORY DELUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522092-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00156</companynumb>
    <primarysource>
      <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>GENERAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522093-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00433</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522094-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00172</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522095-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00254</companynumb>
    <primarysource>
      <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>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIPRES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522096-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00158</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020203</drugenddate>
        <drugtreatmentduration>340</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522097-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004243359JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR I DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>0.5 MG (0.5 MG) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERGOLIDE MESYLATE</medicinalproduct>
        <drugdosagetext>500 MCG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOTEPINE (ZOTEPINE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE MALEATE (LEVOMEPROMAZINE MALEATE)</medicinalproduct>
        <drugdosagetext>50 MG (50 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522098-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00230</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522099-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207509</companynumb>
    <primarysource>
      <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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARTILAGE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</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>20030101</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>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>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522100-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00643</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522101-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00648</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522102-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00647</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522103-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000042</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.5755</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</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>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>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN (GENERAL HEALTH)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522104-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00303</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522105-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098288</companynumb>
    <primarysource>
      <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 PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL MOTILITY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLTERODINE TARTRATE</medicinalproduct>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>4 MG (4 MG ONCE INTERVAL: DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMNIC (TAMSULOSIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522106-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00644</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522107-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00747</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522108-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00777</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522109-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000101</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST 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>19990621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P30071</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522110-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00412</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522111-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00645</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522112-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00646</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522113-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D01200404465</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCULUS URETERIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>20164</drugauthorizationnumb>
        <drugdosagetext>1 MG/KG BID - SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN-FRACTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM SALT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522114-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004228034FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHLAMYDIA SEROLOGY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COOMBS DIRECT TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATO-LENTICULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOPLASMA SEROLOGY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPHEROCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRUS SEROLOGY TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANTIN</medicinalproduct>
        <drugauthorizationnumb>50675</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFUROXAZIDE (NIFUROXAZIDE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXILASE-BACITRACINE (ALPHA-AMYLASE BACTERIAL, BACITRACIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIXOCORTOL PIVALATE (TIXOCORTOL PIVALATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE (DOMPERIDONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SMECTA / OLD FORM / (ALUMINIUM HYDROXIDE-MAGNESIUM CARBONATE GEL, ALUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522115-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000096</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>QW</drugdosagetext>
        <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</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522116-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000102</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUTTOCK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH 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>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522117-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>002#2#2004-00283</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPISTHOTONUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugauthorizationnumb>17854</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522118-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000103</companynumb>
    <primarysource>
      <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>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</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>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522119-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>0001</companynumb>
    <primarysource>
      <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>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CO-TUSS-V (GUAIFENESIN, HYDROCODONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR (ZIRLUKFAST)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUIATUSS AC (GUAIFENESIN, CODEINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522120-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000104</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JAW 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>20011031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P30088</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030915</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522121-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US013524</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51.7101</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORY NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugbatchnumb>P52306</drugbatchnumb>
        <drugauthorizationnumb>20747</drugauthorizationnumb>
        <drugdosagetext>800 UG PRN BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE/APAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522122-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000105</companynumb>
    <primarysource>
      <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>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522123-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097141</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STREPTOMYCIN SULFATE</medicinalproduct>
        <drugauthorizationnumb>60076</drugauthorizationnumb>
        <drugdosagetext>0.5 GRAM 3 IN 1 WK, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugdosagetext>200 MG (1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>200 MG (1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugdosagetext>300 MG (1 D),  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL (ETHAMBUTOL)</medicinalproduct>
        <drugdosagetext>500 MG (1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRAZINAMIDE</medicinalproduct>
        <drugdosagetext>1 GRAM (1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFCAPENE PIVOXIL HYDROCHLORIDE (CEFCAPENE PIVOXIL HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522124-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW19462</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.9363</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>200 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>600 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENTERMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522125-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24515</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>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522126-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24410</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>5 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522127-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004085239</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDURA XL</medicinalproduct>
        <drugauthorizationnumb>19668</drugauthorizationnumb>
        <drugdosagetext>4 MG (4 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522128-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041200278</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.7507</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNKNOWN PSYCH DRUG (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL (ETHANOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATIONS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522129-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097553</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA PAROXYSMAL NOCTURNAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LONITEN</medicinalproduct>
        <drugauthorizationnumb>18154</drugauthorizationnumb>
        <drugdosagetext>5 MG DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522130-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-04967</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE POLACRILEX</medicinalproduct>
        <drugauthorizationnumb>74707</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE POLACRILEX</medicinalproduct>
        <drugauthorizationnumb>74707</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE POLACRILEX</medicinalproduct>
        <drugdosagetext>2 PIECE, TO START WITH, BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugdosagetext>4 PIECE AT A TIME, 1 BOX Q 2DAYS, BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522131-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097447</companynumb>
    <primarysource>
      <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>APRAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLTERODINE (TOLTERODINE)</medicinalproduct>
        <drugauthorizationnumb>20771</drugauthorizationnumb>
        <drugdosagetext>1 MG (1 MG, QD INTERVAL:  EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLLAKIURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMCONCOR  (BISOPROLOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMASPAN (ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522132-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000424</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522133-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA031049961</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANIMAL BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED GASTRIC EMPTYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMOGYI PHENOMENON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN L</medicinalproduct>
        <drugbatchnumb>6RN54M</drugbatchnumb>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>10 U/2 DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN U</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILETIN-BEEF/PORK REGULAR INSULIN(INSULIN, ANIMAL)</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugdosagetext>14 U DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPH ILETIN I (BEEF-PORK)</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19660101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRA-LENTE ILETIN INSULIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19681209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILETIN-BEEF/PORK SEMILENTE  INSULIN(INSULIN, ANIMAL</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19681209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENTE ILETIN (BEEF-PORK) INSULIN ZINC</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN-INSULIN -ANIMAL (INSUL</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522134-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004094777</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM GROWTH ACCELERATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>20280</drugauthorizationnumb>
        <drugdosagetext>0.2 MG, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522135-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>205133</companynumb>
    <primarysource>
      <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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</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>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMELOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522136-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040827</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-379225</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>23</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>OTITIS MEDIA ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040804</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040802</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040728</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS MEDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040817</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMELIAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROTEINURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040817</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BILE OUTPUT INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522137-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030903</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-346300</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>THERAPY WAS STOPPED AND RESTARTED MORE THAN ONCE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>DOSAGE REGIMEN REPORTED AS: 90MG WEEKLY.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030509</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522138-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20011130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-302932</companynumb>
    <primarysource>
      <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>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS INFECTIVE</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>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS ANI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19910515</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19921029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930401</drugenddate>
        <drugtreatmentduration>155</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19941015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19951116</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980827</drugenddate>
        <drugtreatmentduration>121</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugindication>SINOBRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBITUSSIN AC</medicinalproduct>
        <drugindication>SINUS CONGESTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRACYCLINE</medicinalproduct>
        <drugdosagetext>STOPPED WHILST ON AZITHROMYCIN.</drugdosagetext>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOLOG</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>1 CONCOMITANT DRUG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DHEA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIBID</medicinalproduct>
        <drugindication>SINOBRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIBID DM</medicinalproduct>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCOLATE</medicinalproduct>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTEX LA</medicinalproduct>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM A-D</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXICYCLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPRELAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAPROX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000523</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522139-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>205948</companynumb>
    <primarysource>
      <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>ANIMAL BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P01047</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522140-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CEL-2004-01867-ROC</companynumb>
    <primarysource>
      <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>BLOOD BICARBONATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE HCL</medicinalproduct>
        <drugauthorizationnumb>85799</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COMPLETED SUICIDE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COMPLETED SUICIDE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PSEUDOEPHEDRINE (PSEUDOEPHEDRINE)</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COMPLETED SUICIDE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIET SOLUTION</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COMPLETED SUICIDE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522141-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-371706</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040406</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522142-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000080</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER PERFORATION</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>4522143-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-383843</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE SUBCUTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
        <drugtreatmentduration>433</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
        <drugtreatmentduration>433</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARNAL</medicinalproduct>
        <drugdosagetext>REPORTED AS TAMSULOSIN HYDROCHLORIDE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522144-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040408</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-364125</companynumb>
    <primarysource>
      <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>CATHETER SITE RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPEN WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
        <drugtreatmentduration>336</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522145-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000054</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522146-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040804</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-376803</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLAT FEET</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOLLICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE WITH AURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOCHONDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLEX SYMPATHETIC DYSTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENOSYNOVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LICHEN SCLEROSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980616</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990216</drugenddate>
        <drugtreatmentduration>246</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WESTCORT OINTMENT</medicinalproduct>
        <drugdosagetext>DOSAGE REGIMEN REPORTED AS UP TO BID.</drugdosagetext>
        <drugindication>LICHEN SCLEROSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLOCAINE CREAM</medicinalproduct>
        <drugindication>LICHEN SCLEROSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTROBAN</medicinalproduct>
        <drugindication>LICHEN SCLEROSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMOVATE</medicinalproduct>
        <drugindication>LICHEN SCLEROSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522147-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184405</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER MALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALAGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522148-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000098</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.1532</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</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>20010701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX LIQUID</medicinalproduct>
        <drugdosagetext>30 UG;QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVITAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522149-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184443</companynumb>
    <primarysource>
      <qualification>3</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>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG/M2 DAY</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUPENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPRAM TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN (GABAPENTIN PFIZER)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522150-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184199</companynumb>
    <primarysource>
      <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>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>5 MG/ 1 DAY</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522151-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184234</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522152-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE521324AUG04</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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSPASM CORONARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL COLD AND SINUS</medicinalproduct>
        <drugauthorizationnumb>19771</drugauthorizationnumb>
        <drugdosagetext>^FIVE WITHIN A FEW DAYS^</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522153-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184110</companynumb>
    <primarysource></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>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>20 MG DAY</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE (VALPROATE SEMISDOIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522154-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-372808</companynumb>
    <primarysource>
      <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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040131</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALONAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040131</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELGIN G</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040131</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522155-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-387441</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522156-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-384414</companynumb>
    <primarysource>
      <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>ASEPTIC NECROSIS BONE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDEX EC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA-D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRA DS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522157-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-035641</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugbatchnumb>131282T</drugbatchnumb>
        <drugauthorizationnumb>19596</drugauthorizationnumb>
        <drugdosagetext>20 ML, 1DOSE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522158-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-383714</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522159-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-387564</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION MISSED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
        <drugtreatmentduration>1396</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
        <drugtreatmentduration>1396</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522160-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-384954</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS INFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</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>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522161-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-387614</companynumb>
    <primarysource>
      <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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERCINE</medicinalproduct>
        <drugdosagetext>ROUTE: IJ</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DORMICUM (INJ)</medicinalproduct>
        <drugdosagetext>ROUTE REPORTED AS INJECTION. DOSAGE: 1ML/H BY CONTINUOUS INFUSION.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVIATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVIATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522162-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-387599</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugdosagetext>THERAPY STARTED IN THE FALL OF 1999</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522163-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>205361</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.4003</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER STAGE II</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</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>20030901</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>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522164-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ROCHE-387602</companynumb>
    <primarysource>
      <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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXIN-SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522165-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-387679</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN HYDATIDIFORM MOLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
        <drugtreatmentduration>140</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522166-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-387856</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugdosagetext>LONG TERM THERAPY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522167-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-387794</companynumb>
    <primarysource>
      <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 OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALLORY-WEISS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522168-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-388456</companynumb>
    <primarysource>
      <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>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERCINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522169-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-388306</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOOL ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TICLID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugdosagetext>DRUG USE DURATION STATED AS YEARS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522170-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-388169</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBELLAR TUMOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041127</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522171-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-388060</companynumb>
    <primarysource>
      <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>BONDRONAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522172-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-388296</companynumb>
    <primarysource>
      <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>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522173-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12779955</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugdosagetext>2 PUFFS</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522174-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100518</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.1324</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB (CELECOXIB)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE (ESOMEPRAZOLE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522175-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100272</companynumb>
    <primarysource>
      <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>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20882</drugauthorizationnumb>
        <drugdosagetext>48 00 MG (1200 MG, 4 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522176-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099661</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN KAPSEAL</medicinalproduct>
        <drugauthorizationnumb>84349</drugauthorizationnumb>
        <drugdosagetext>300 MG, (100 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522177-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098856</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.9363</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM (PHENYTOIN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACITRETIN (ACITRETIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIFLUPERAZINE (TRIFLUPERAZINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522178-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>206820</companynumb>
    <primarysource>
      <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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIA</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>20011123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522179-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098814</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.1417</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>80 MG (80 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>900 MG (300 MG, 3 IN 1 D)</drugdosagetext>
        <drugindication>NERVE INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>NERVOUSNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522180-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>206846</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>ARTERIAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC 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>19990501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522181-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004093092</companynumb>
    <primarysource>
      <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>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522182-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099444</companynumb>
    <primarysource>
      <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>ANTICONVULSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>200 MG (2 IN 1 D)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522183-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-035490</companynumb>
    <primarysource>
      <qualification>5</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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040809</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522184-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100027</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
        <drugauthorizationnumb>20931</drugauthorizationnumb>
        <drugdosagetext>1000 MCG (500 MCG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522185-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-035566</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>21037</drugauthorizationnumb>
        <drugdosagetext>16 ML, 1 DOSE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522186-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210515</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.6</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>M21831</drugbatchnumb>
        <drugdosagetext>375 MG, Q2W, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR (FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL (ALBUTEROL, ALBUTEROL SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-FUNGAL CREAM (ANTIFUNGAL AGENT NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522187-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>209960</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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>1.8 ML, 1/MONTH, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522188-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210600</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC MYXOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522189-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207979</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522190-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0281797-00</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN SULFATE IN SODIUM CHLORIDE INJECTION (GENTAMICIN SULFATE/SO</medicinalproduct>
        <drugauthorizationnumb>62414</drugauthorizationnumb>
        <drugdosagetext>DAILY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522191-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US014352</companynumb>
    <primarysource>
      <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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugauthorizationnumb>20717</drugauthorizationnumb>
        <drugindication>FATIGUE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugauthorizationnumb>20717</drugauthorizationnumb>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522192-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-025259</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522193-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210655</companynumb>
    <primarysource>
      <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>ALKALOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLUBBING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ALVEOLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugdosagetext>375 MG/M2, Q3W</drugdosagetext>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN (DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522194-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108592</companynumb>
    <primarysource>
      <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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522195-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184045</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>XIGRIS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522196-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184287</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>PO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL WEDGE PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522197-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE644223NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRECANCEROUS CELLS PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMEAR CERVIX ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULNAR NERVE PALSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL (BUPROPION HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522198-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_000745907</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTROPHY BREAST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF4G15A</drugbatchnumb>
        <drugdosagetext>20 UG DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</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>VITAMIN C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522199-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184589</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522200-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_041105246</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG/1 DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN (FLUINDIONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPALGIC (TRAMADOL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUPANTOL (PANTOPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FONZYLANE (BUFLOMEDIL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAYEXALATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE (ZOPICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GELOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOMYST(ACETYLCYSTEINE SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522201-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108314</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522202-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-198</companynumb>
    <primarysource></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>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>5 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522203-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108275</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ELECTROLYTES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT (ERYTHROPOIETIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522204-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_041105237</companynumb>
    <primarysource>
      <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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG/1 IN THE MORNING</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LODOZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENITEC(ENALAPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINUTREN DESSERT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPASMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIALGIREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522205-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184418</companynumb>
    <primarysource>
      <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>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522206-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-561</companynumb>
    <primarysource></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>PARAPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>5 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020214</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522207-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004NO16124</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugindication>POLYMYALGIA RHEUMATICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VARICES OESOPHAGEAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>3 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522208-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210582</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>24.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOCHONDROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTROPIN</medicinalproduct>
        <drugauthorizationnumb>19676</drugauthorizationnumb>
        <drugdosagetext>0.6 MG, QD, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERIACTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522209-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBS041115977</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>30</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugbatchnumb>A061375</drugbatchnumb>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>18 MG</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522210-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1742</companynumb>
    <primarysource>
      <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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugbatchnumb>4-RXF-2</drugbatchnumb>
        <drugauthorizationnumb>19658</drugauthorizationnumb>
        <drugdosagetext>1 TABLET QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUCOUS MEMBRANE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS/MINERALS/DIETARY SUPPLEMENTS (NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEMANTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GALANTAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522211-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1743</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITIN-D</medicinalproduct>
        <drugauthorizationnumb>20470</drugauthorizationnumb>
        <drugdosagetext>1 TABLET QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POSTNASAL DRIP</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEMANTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522212-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC040438731</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>21253</drugauthorizationnumb>
        <drugdosagetext>10 MG/1 DAY</drugdosagetext>
        <drugindication>AGITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DROPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZOLAN(TRAZODONE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522213-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041182724</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>7SD31M</drugbatchnumb>
        <drugauthorizationnumb>21017</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522214-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108654</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>21017</drugauthorizationnumb>
        <drugdosagetext>30 U DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522215-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184125</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>8RA90M</drugbatchnumb>
        <drugauthorizationnumb>21017</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522216-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040909</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12697041</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>AUC 6</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED DISODIUM</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugdosagetext>DOSE: 200 CGY</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
        <drugtreatmentduration>47</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>128 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B12</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522217-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP13931</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILE DUCT CANCER</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>DUODENAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCHOL</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
        <drugtreatmentduration>36000</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANDOLAPRIL</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522218-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184506</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOE AMPUTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522219-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC041141525</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORSTEO(TERPARATIDE)</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG/1 DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALCIPOS-D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522220-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE04028</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCOL</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
        <drugtreatmentduration>161</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522221-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19991112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0315865A</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.22</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEREALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991103</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522222-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-035494</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522223-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108233</companynumb>
    <primarysource></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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522224-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC041141463</companynumb>
    <primarysource>
      <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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522225-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108290</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>20 U</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>5 U</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522226-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_041105267</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORSTEO(TERIPARATIDE)</medicinalproduct>
        <drugbatchnumb>FF3T83M</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL(TRIMETAZIDINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INIPOMP(PANTOPRAZOLE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522227-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-551</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>15 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext> 5 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522228-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108294</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY DISSECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>7SE05P</drugbatchnumb>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>7RK81P</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522229-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-567</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19871023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>5 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>2.5 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>2.5 MG 1X PER 2 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>^20^ 1/2 DAILY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>^5^ DAILY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3 VIALS EVERY 8 WEEKS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID AC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL (AMMONIUM CHLORIDE/CHLOROFORM/DIPHENHYDRAMINE HYDROCHLORIDE/M</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B1 TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENEST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBERCON (CALCIUM POLYCARBOPHIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRUCEL (METHYLCELLULOSE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522230-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108369</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE REDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>7RK81P</drugbatchnumb>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>6 U/2 DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>7SJ17M</drugbatchnumb>
        <drugdosagetext>10 U/2 DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>8RG90R</drugbatchnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILETIN-BEEF/PORK REGULAR INSULIN (INSULIN, ANIMAL)</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19570101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19820101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPH ILETIN I (BEEF-PORK)</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19570101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19820101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522231-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184468</companynumb>
    <primarysource>
      <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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEEDING TUBE INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>7SC84M</drugbatchnumb>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>7RR20M</drugbatchnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522232-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-2004-031566</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTHESOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN (YASMIN 20 (DRSP+ EE (SH T 186 D))) (DROSPIRENONE, ETHINYLESTRA</medicinalproduct>
        <drugauthorizationnumb>21098</drugauthorizationnumb>
        <drugdosagetext>24/28 D, 1X/DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522233-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-597</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANT SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>10 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED ANTI-INFLAMMATORY AGENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522234-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004093584</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522235-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099286</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522236-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24364</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAMMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugauthorizationnumb>17970</drugauthorizationnumb>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINZIDE</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>QUININE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522237-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099325</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522238-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CERZ-10719</companynumb>
    <primarysource></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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>20367</drugauthorizationnumb>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522239-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101111</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENILE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPROSTADIL</medicinalproduct>
        <drugauthorizationnumb>21212</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522240-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004094467</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 PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522241-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-10889</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</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>20040514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522242-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184512</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522243-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200420673BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117.9352</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21277</drugauthorizationnumb>
        <drugdosagetext>400 MG, ONCE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL NEB (SALBUTAMOL)</medicinalproduct>
        <drugdosagetext>2.5 MG, ONCE, RESPIRATORY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugdosagetext>ONCE, RESPIRATORY (INHALATION)</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugdosagetext>1G, ONCE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugdosagetext>650 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BCG (BACILLE CALMETTE-GUERIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZMACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522244-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184570</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG96R</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522245-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-2004-035523</companynumb>
    <primarysource>
      <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>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>K22701</drugbatchnumb>
        <drugauthorizationnumb>21098</drugauthorizationnumb>
        <drugdosagetext>24/28 D, 1X/DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040429</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522246-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184072</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOE AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>75 U DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN (GABAPENTIN PFIZER)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522247-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184052</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE DIET</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>FF3AM4A</drugbatchnumb>
        <drugdosagetext>50 U DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522248-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SHC-2002-008022</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>21098</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522249-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020913</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0380945A</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</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>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugdosagetext>37.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522250-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184446</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GANGRENE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEG AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOE AMPUTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>FF3Z16C</drugbatchnumb>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522251-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2004-032293</companynumb>
    <primarysource>
      <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>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040312</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522252-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184091</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBYAX</medicinalproduct>
        <drugbatchnumb>7EL41A</drugbatchnumb>
        <drugauthorizationnumb>21520</drugauthorizationnumb>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugbatchnumb>7EJ93M</drugbatchnumb>
        <drugdosagetext>2.5 MG/1 DAY</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522254-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-2004-035888</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CERVIX CARCINOMA STAGE 0</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IUCD COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVONORGESTREL</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522255-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100390</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
        <drugauthorizationnumb>20607</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522256-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108648</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBYAX</medicinalproduct>
        <drugauthorizationnumb>21520</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522257-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184160</companynumb>
    <primarysource>
      <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>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRESSORS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI FUNGALS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522258-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004241627CA</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL DYSPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522259-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-2004-035688</companynumb>
    <primarysource>
      <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>BETA HAEMOLYTIC STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522260-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101077</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANORECTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLEFT PALATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYPTORCHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOSPADIAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTELORISM OF ORBIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE SEPARATION OF PLACENTA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNDACTYLY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOSTINEX</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, TWICE  WEEKLY, ORAL</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522261-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0405103315</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADENOMA BENIGN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>12.5 MG/1 AT BEDTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE XR(METFORMIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR (SIMVASTATIN RATIOPHARM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR (ATORVASTATIN CALCIUM0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA (FEXOFENADINE HYDROCHLORDIE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORCET-HD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASCORT (BUDESONIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SURBEX-T</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYLANTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLORAZEPATE DIPOTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522262-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041105258</companynumb>
    <primarysource>
      <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>GASTROINTESTINAL EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522263-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108131</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BILE DUCT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugindication>CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE 0.9%</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANULOCYTE COLONY STIMULATING FACTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROTONIN ANTAGONIST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522264-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210838</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BOVINE TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL ADHESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugdosagetext>1 MG/KG, 1/WEEK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODURETIC 5-50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (ALBUTEROL, ALBUTEROL SULFATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522265-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004094657</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48.0813</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>150 MG (150 MG, 1ST  INJ., EVERY 10-13 WEEKS), INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522266-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0391831A</companynumb>
    <primarysource>
      <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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</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 DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522267-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098217</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>EVERY 12 WEEKS, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522268-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210621</companynumb>
    <primarysource>
      <qualification>3</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATYPICAL MYCOBACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL ADHESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugdosagetext>1 MG/KG, 1/WEEK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODURETIC 5-50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (ALBUTEROL, ALBUTEROL SULFATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522269-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184625</companynumb>
    <primarysource>
      <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>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522270-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100145</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
        <drugauthorizationnumb>18154</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, SINGLE INTERVAL: DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522271-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184295</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugindication>PLEURAL MESOTHELIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522272-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040978448</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC URAEMIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY MEDIASTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC NEOPLASM MALIGNANCY UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOTAL LUNG CAPACITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1500 MG OTHER</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE (DOCETAXEL0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL (CICLOSTAZOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURICEF 9CEFADROXIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX (BUMETANIDE0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCREASE MT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANZEMET (DOLASETRON MESILATE0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE (MEGESTEROL ACETATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522273-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004093059</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522274-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210818</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED ACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFALIZUMAB (EFALIZUMAB) PWDR + SOLVENT, INJECTION SOLN, 125MG</medicinalproduct>
        <drugdosagetext>1 MG/KG, 1/WEEK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID (NON-STEROIDAL ANTI-INFLAMMATORY DRUG NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETANERCEPT (ETANERCEPT)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522275-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>42001112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184593</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP TALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522277-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184270</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>109</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUNGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>8RS00M</drugbatchnumb>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>90 U DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>7RK32M</drugbatchnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522278-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184433</companynumb>
    <primarysource>
      <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>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522280-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004081132</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522282-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108641</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>170</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>40 MG DAY</drugdosagetext>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522283-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004085695</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORNEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELDOX (CAPSULES) (ZIPRASIDONE)</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>60 MG, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522285-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041182831</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522286-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097801</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.37</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYPTORCHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA CONGENITAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugauthorizationnumb>20779</drugauthorizationnumb>
        <drugdosagetext>2500 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV TEST POSITIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE W/LAMIVUDINE (LAMIVUDINE, ZIDOVUDINE)</medicinalproduct>
        <drugdosagetext>2500 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV TEST POSITIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>600 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV TEST POSITIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugdosagetext>600 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV TEST POSITIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE (TENOFOVIR DISOPROXIL FUMARATE)</medicinalproduct>
        <drugdosagetext>300 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV TEST POSITIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522287-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184079</companynumb>
    <primarysource>
      <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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522289-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184134</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522291-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098596</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</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>ESCHERICHIA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>21266</drugauthorizationnumb>
        <drugdosagetext>400 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASPOFUNGIN ACETATE (CASPOFUNGIN ACETATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522292-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184163</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522293-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210513</companynumb>
    <primarysource>
      <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>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMOOTH MUSCLE ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>1000 MG, DAYS 1+15, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>100 MG, DAYS 1+15, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>12.5 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522294-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184104</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522296-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_041004910</companynumb>
    <primarysource>
      <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>BIOPSY SKIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1200 MG OTHER</drugdosagetext>
        <drugindication>BILE DUCT CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPHREN (ONDANSETRON HYDROHCLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTISKENAN (MORPHINE SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN ELIXIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INIPOMP (PANTOPRAZOLE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522297-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184621</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVERSION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONIC CLONIC MOVEMENTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DROSPIRENONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMX (TOPIRAMATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522299-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_040804576</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCRATCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2/3 OTHER</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522300-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108266</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTEX CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT AQ (TRIAMCINOLONE ACETONIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN (NAPROXEN MEPHA)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522302-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101076</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANORECTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLEFT PALATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYPTORCHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOSPADIAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTELORISM OF ORBIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE SEPARATION OF PLACENTA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNDACTYLY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULTRASOUND ANTENATAL SCREEN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOSTINEX</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>(0.5 MG, TWICE WEEKLY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522303-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041105213</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRE-ECLAMPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>19 U DAY</drugdosagetext>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522306-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210717</companynumb>
    <primarysource>
      <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>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>600 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522307-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184397</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522308-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184417</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522309-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-00770</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN S DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.20 MG,UNK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522311-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040977146</companynumb>
    <primarysource>
      <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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPERPIGMENTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>1100 MG OTHER</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT (ERYTHROPOIETIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522312-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210729</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN (DOXORUBICIN, DOXORUBICIN HYDROCHLORIDE)</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522313-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A044-002-005324</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>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</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>20041016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN (WARFARIN)</medicinalproduct>
        <drugdosagetext>4 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522315-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108017</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBYAX</medicinalproduct>
        <drugauthorizationnumb>21520</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522316-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031013</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0399037B</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE EXACERBATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALMETEROL</medicinalproduct>
        <drugdosagetext>50MCG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010906</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522317-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040220</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0499969A</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522318-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A044-002-005333</companynumb>
    <primarysource>
      <qualification>3</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKAEMIA PLASMACYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</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</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>15 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULPHATE ANHYDROUS (FERROUS SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMOL (APOREX)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRALAX (MICROLAX)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522319-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040978691</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>845 MG</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522321-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410641BYL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROXAN (CIPROFLOXACIN HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>19537</drugauthorizationnumb>
        <drugdosagetext>TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PL</medicinalproduct>
        <drugdosagetext>TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DASEN (SERRAPEPTASE)</medicinalproduct>
        <drugdosagetext>TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANEXAMIC ACID</medicinalproduct>
        <drugdosagetext>TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCASAAL (MEFENAMIC ACID)</medicinalproduct>
        <drugdosagetext>250 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041010</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522322-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184348</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHUNT OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN (GABAPENTIN PFIZER)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMOX (ACETAZOLAMIDE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>^ACNE MEDICINE^</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522323-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040220</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0499994A</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522325-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-0007209</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANTED LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITOCHONDRIAL CYTOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITOCHONDRIAL TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugauthorizationnumb>21356</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR SULFATE (ABACAVIR SULFATE)</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ (EFAVIRENZ)</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE (STAVUDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS (TACROLIMUS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A (PEGINTERFERON ALFA-2A)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522326-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184247</companynumb>
    <primarysource>
      <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>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522328-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040220</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0500235A</companynumb>
    <primarysource>
      <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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522329-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410529BYL</companynumb>
    <primarysource></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>ERECTION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522330-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184361</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON (MIRTAZAPINE ORIFARM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522332-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-0007486</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTRIGLYCERIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE (TENOFOVIR DISOPROXIL FUMARATE)</medicinalproduct>
        <drugauthorizationnumb>21356</drugauthorizationnumb>
        <drugdosagetext>300 MG, 1 IN 48 HR, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR SULFATE (ABACAVIR SULFATE)</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040420</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522333-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040917</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0526621A</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugbatchnumb>445</drugbatchnumb>
        <drugdosagetext>250MCG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAPROFENIC ACID</medicinalproduct>
        <drugdosagetext>350MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>10MG WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030904</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522334-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410523BYL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS A POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL HCL 20 MG (VARDENAFIL HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL HCL 20 MG (VARDENAFIL HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL HCL 20 MG (VARDENAFIL HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL HCL 20 MG (VARDENAFIL HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL HCL 20 MG (VARDENAFIL HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL HCL 20 MG (VARDENAFIL HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL HCL 20 MG (VARDENAFIL HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL HCL 20 MG (VARDENAFIL HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>1 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLITA-T3 INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOFLUID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522336-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>062-20785-04120051</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE - PHARMION (THALIDOMIDE) (100 MILLIGRAM, CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IDARUBICIN (IDARUBICIN)</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGFILGRASTIM (PEGFILGRASTIM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522337-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0534017B</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COARCTATION OF THE AORTA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOPLASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522338-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535749A</companynumb>
    <primarysource>
      <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>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522339-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535878A</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugbatchnumb>4G041</drugbatchnumb>
        <drugdosagetext>5ML FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522341-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>167-20785-04120050</companynumb>
    <primarysource>
      <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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>50 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN (LOSARTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522342-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG01324</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERMITTENT CLAUDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VON WILLEBRAND'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZESTORETIC</medicinalproduct>
        <drugauthorizationnumb>19888</drugauthorizationnumb>
        <drugdosagetext>1 DF QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TANAKAN</medicinalproduct>
        <drugdosagetext>2 DF QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040610</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522343-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GLAXOSMITHKLINE-A0536014A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522344-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411107718</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLADDER PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE-IV (GEMCITABINE)</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2 OTHER</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>200 MG/M2 OTHER</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA XL (NIFEDIPINE PA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRANBERRY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON (DEXAMETHASONE SODIUM PHOSPAHTE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522345-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536230A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANNAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASAREL</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>240MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522346-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536384A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILE DUCT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</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>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>20MEQ PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCURETIC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522347-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536403B</companynumb>
    <primarysource>
      <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>FINGER DEFORMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522348-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536564A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522349-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536627A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER RECURRENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTOSE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</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>TIAZAC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODURETIC 5-50</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522350-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-UKI-07957-01</companynumb>
    <primarysource>
      <qualification>3</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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRAMIL (CITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522351-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20011031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0125952A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD KETONE BODY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTRIGLYCERIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTATE PYRUVATE RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACROCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC FUNCTION TEST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001013</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugdosagetext>2500MG TWICE PER DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIXIVAN</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GYNOPEVARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMEXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPROSONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522352-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19920128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-B0157001A</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
        <drugdosagetext>6G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522353-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0274108B</companynumb>
    <primarysource>
      <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>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990318</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990318</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
        <drugdosagetext>2250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990324</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </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>20010401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522354-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-B0314536A</companynumb>
    <primarysource>
      <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>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTIONS INVOLUNTARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugdosagetext>450MG TWICE PER DAY</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIVALPROEX SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522356-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040907</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0344956A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522357-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-GLAXOSMITHKLINE-B0346890A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EDRONAX</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERAZETTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522358-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0347537A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATINE PHOSPHOKINASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FASTIC</medicinalproduct>
        <drugdosagetext>90MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXAN</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522359-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041008</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GLAXOSMITHKLINE-B0347975A</companynumb>
    <primarysource>
      <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>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>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHOPNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040728</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522360-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0349397A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE BITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugdosagetext>20MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040905</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXEL</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040908</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOCTAMIDE</medicinalproduct>
        <drugdosagetext>28UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040905</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522361-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GLAXOSMITHKLINE-B0350137B</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugdosagetext>2.3MGM2 SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522362-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0358121A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLIXONASE</medicinalproduct>
        <drugdosagetext>1PUFF PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRONCHODUAL</medicinalproduct>
        <drugdosagetext>1UNIT THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELFAST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AERIUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZADITEN</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVE PILL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522363-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0358121B</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COARCTATION OF THE AORTA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLIXONASE</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRONCHODUAL</medicinalproduct>
        <drugdosagetext>1UNIT THREE TIMES PER DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELFAST</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AERIUS</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZADITEN</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVE PILL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522364-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0358226A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040803</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040729</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROXAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040731</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040812</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPERAZON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040809</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040807</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040806</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAC B</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYMYXIN B SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040806</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGIZONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040805</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040827</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROTONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040727</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOGLOBINS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040730</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HAPTOGLOBIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040728</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522365-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0358386A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040829</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugdosagetext>2UNIT PER DAY</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040829</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORSET</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HAVLANE</medicinalproduct>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugdosagetext>2UNIT PER DAY</drugdosagetext>
        <drugindication>BETA HAEMOLYTIC STREPTOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040829</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANNABIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOBACCO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522366-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0358657A</companynumb>
    <primarysource>
      <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>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugdosagetext>245MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugdosagetext>90MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIPRANAVIR</medicinalproduct>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522367-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0358682A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
        <drugdosagetext>20MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>280MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STIRIPENTOL</medicinalproduct>
        <drugdosagetext>750MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522368-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0358742A</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BECOTIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522369-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0358925A</companynumb>
    <primarysource>
      <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>GRANULOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>60MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>50MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugdosagetext>500MCG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522370-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0358944A</companynumb>
    <primarysource>
      <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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MALARONE</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEMIDAONIL</medicinalproduct>
        <drugdosagetext>2.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LODALES</medicinalproduct>
        <drugdosagetext>1UNIT THREE TIMES PER WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROVEL</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YOHIMBINE</medicinalproduct>
        <drugdosagetext>2MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INIPOMP</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERMIXON</medicinalproduct>
        <drugdosagetext>1UNIT TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>50MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522371-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0409105579</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFAECATION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>7SG69M</drugbatchnumb>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN (INSULIN HUMAN INJECTION, ISOPHANE )</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522372-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>4694</companynumb>
    <primarysource>
      <qualification>3</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYCAMTIN</medicinalproduct>
        <drugdosagetext>1MGM2 PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOSTRIDIUM BUTYRICUM</medicinalproduct>
        <drugdosagetext>9G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522373-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0359066A</companynumb>
    <primarysource>
      <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>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522374-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0359069A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPIRIDE</medicinalproduct>
        <drugdosagetext>25MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSED MOOD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040727</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENBIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIZE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522375-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0359174A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYLAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522376-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0359248A</companynumb>
    <primarysource>
      <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>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOCET</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIFLUCAN</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522377-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0359293A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</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 CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>1G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA BACTERIAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIFLUCAN</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040727</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AOTAL</medicinalproduct>
        <drugdosagetext>1998MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALCOHOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040727</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENITEC</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERESTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OGAST</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040715</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522378-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GLAXOSMITHKLINE-B0359344A</companynumb>
    <primarysource>
      <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>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIRTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINITRAN</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM PANTOTHENATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522379-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0359354A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugdosagetext>1G SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522380-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-GLAXOSMITHKLINE-B0359371A</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINIDIAB</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522381-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>387181</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030115</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030115</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522382-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>387237</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040106</drugenddate>
        <drugtreatmentduration>303</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030207</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522383-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359929A</companynumb>
    <primarysource>
      <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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>6MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>2U PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugdosagetext>250MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugdosagetext>245MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
        <drugdosagetext>2.5G PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040506</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522384-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004/LAMICTALWWW</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>100U UNKNOWN</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATIONS</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522385-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0045244A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFONYLUREA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELIX</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITOXIN TAB</medicinalproduct>
        <drugdosagetext>.1MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522386-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19910925</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-G0008387A</companynumb>
    <primarysource>
      <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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME SODIUM</medicinalproduct>
        <drugdosagetext>3G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UROSEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19860101</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SKIN INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SKIN INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SKIN INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOPERAZONE SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UROSEPSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UROSEPSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN SULPHATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522388-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004CA15731</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522389-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>R301129-3002-CDN</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>E3810 (RABEPRAZOLE)</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>E3810 (RABEPRAZOLE)</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE (RAMIPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELTROXIN (LEVOTHYROXINE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522390-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA020617097</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACOUSTIC NEUROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOTOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>FF3T89C</drugbatchnumb>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN U</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPH ILETIN I (BEEF-PORK)</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19620101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19820101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILETIN-BEEF/PORK REGULAR INSULIN (INSULIN, ANIMAL)</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19620101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19820101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522391-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004HU16296</companynumb>
    <primarysource>
      <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>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF CELL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIXED CONNECTIVE TISSUE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugindication>POLYARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522392-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16379</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522393-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BR16309</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE VIA BREAST MILK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO PAIN STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINOSORO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522394-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03536</companynumb>
    <primarysource>
      <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>POSTMENOPAUSAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522396-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004GB16175</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTEPARTUM HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMAL NEWBORN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTA PRAEVIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>2 MG/KG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>175 MG, BID</drugdosagetext>
        <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>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522397-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_040199862</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL DRAINAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYMPANIC MEMBRANE PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>6SH45M</drugbatchnumb>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>4 U</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522398-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12781233</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522399-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-BRISTOL-MYERS SQUIBB COMPANY-12786091</companynumb>
    <primarysource>
      <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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VP-16</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPHOSPHAMIDE</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522400-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-12782322</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROVEL TABS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522402-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12777173</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041003</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COAPROVEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041003</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041003</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041003</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERVEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522403-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041081215</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugauthorizationnumb>19640</drugauthorizationnumb>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DDAVP (DESMOPRESSIN ACETATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522404-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12776944</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522405-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004PT16126</companynumb>
    <primarysource>
      <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>APHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIORAL (NCH)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522408-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040876003</companynumb>
    <primarysource>
      <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>CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FULL BLOOD COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugauthorizationnumb>19640</drugauthorizationnumb>
        <drugdosagetext>0.3 MG/1 DAY</drugdosagetext>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030620</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522409-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004JP17318</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>350 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000414</drugenddate>
        <drugtreatmentduration>14400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>250 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000518</drugenddate>
        <drugtreatmentduration>48960</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>220 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000612</drugenddate>
        <drugtreatmentduration>36000</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>250 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010328</drugenddate>
        <drugtreatmentduration>289</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>200 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020610</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>2 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000428</drugenddate>
        <drugtreatmentduration>36000</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>1.5 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020610</drugenddate>
        <drugtreatmentduration>773</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>20 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugdosagetext>85MG DR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000404</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522410-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098804</companynumb>
    <primarysource>
      <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>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVISTATIN SODIUM (PRAVASTATIN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS(ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522411-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE04061</companynumb>
    <primarysource>
      <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>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACE INHIBITOR NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRANOC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522413-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041080263</companynumb>
    <primarysource>
      <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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugindication>MESOTHELIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522415-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0409105406</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2 OTHER</drugdosagetext>
        <drugindication>MESOTHELIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE-IV (GEMCITABINE)</medicinalproduct>
        <drugdosagetext>1250 MG/M2 OTHER</drugdosagetext>
        <drugindication>MESOTHELIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E (HERBAL OIL NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522417-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098582</companynumb>
    <primarysource>
      <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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SILDENAFIL (SILDENAFIL)</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>(50 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030411</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522418-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040323</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US03371</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>150 MG, QHS</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522419-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US10772</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AROMYCIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040307</drugenddate>
        <drugtreatmentduration>175</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugdosagetext>5 ML, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
        <drugtreatmentduration>907</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>2000 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040307</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522420-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_981113025</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYPTORCHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HYPOGLYCAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPH ILETIN I (BEEF-PORK)</medicinalproduct>
        <drugauthorizationnumb>17931</drugauthorizationnumb>
        <drugdosagetext>44 U/DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19520101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILETIN-BEEF/PORK REGULAR INSULIN (INSULIN, ANIMAL)</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19520101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN L</medicinalproduct>
        <drugdosagetext>35 UL IN THE MORNING</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN U</medicinalproduct>
        <drugdosagetext>46 U/IN THE MORNING</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILETIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>6 U/IN THE MORNING</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugdosagetext>12 U/L IN THE MORNINE</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCAGON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLERGY SHOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHROMIUM PICOLINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRACYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522421-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CH16236</companynumb>
    <primarysource>
      <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 ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAPILLARY LEAK SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
        <drugtreatmentduration>31680</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>40 MG/D</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
        <drugtreatmentduration>31680</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALMADORM</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM-SANDOZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPIN AND ISONIAZID</medicinalproduct>
        <drugdosagetext>3 DF/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMPORTAL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522422-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097807</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SINUS ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROTINOLOL HYDROCHLORIDE (AROTINOLOL HYDROCHLORIDE)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522424-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12951</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG (UNSPECIFIED)</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522425-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZONI002050</companynumb>
    <primarysource>
      <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>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEGRAN (ZONISAMIDE)</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG , 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAMAG G (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOHRUS (KETOPROFEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENSCHENT (CLOTRIMAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KERATINAMIN (UREA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNARIDE (SENNOSIDE A+B)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522427-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041080725</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>FF3V52A</drugbatchnumb>
        <drugauthorizationnumb>21017</drugauthorizationnumb>
        <drugdosagetext>45 U DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>FF3S76A</drugbatchnumb>
        <drugdosagetext>5 U/1 DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522428-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040323</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US03371</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>150 MG, QHS</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522429-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZONI002067</companynumb>
    <primarysource>
      <qualification>3</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>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS PSEUDOMONAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAMMONAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTIOUS MONONUCLEOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC INFLAMMATORY RESPONSE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEGRAN (ZONISAMIDE)</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugdosagetext>120 MG</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL (MECOBALAMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN (LOXOPROFEN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEIACT (CEFDITOREN PIVOXIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLELOCK (OLOPATADINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACUATIM (NIDIFLOXACIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS REISIPPU (COLD PACK)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522430-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040978012</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>FF4B61A</drugbatchnumb>
        <drugauthorizationnumb>21017</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522432-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA030946741</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>125</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSULIN RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>FF4M69C</drugbatchnumb>
        <drugauthorizationnumb>21017</drugauthorizationnumb>
        <drugdosagetext>90 U DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522433-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-00485</companynumb>
    <primarysource>
      <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>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.3MG/M2, 1/WEEK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIXIN (CLONIXIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE (VENLAFAXINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522434-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US95102596A</companynumb>
    <primarysource>
      <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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>9ME55M</drugbatchnumb>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>9MF78M</drugbatchnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN-INSULIN-ANIMAL (INSUL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522436-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-00846</companynumb>
    <primarysource>
      <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>DYSPHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORY NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.30 MG/M2, 2/WEEK</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE (OXYCODONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522437-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108417</companynumb>
    <primarysource></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>BREATH ODOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522439-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE04064</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE IMMEASURABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522440-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AC00874</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IATROGENIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITYRIASIS ROSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugauthorizationnumb>19777</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522441-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE03859</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM-DURA</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZID</medicinalproduct>
        <drugdosagetext>12.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIGANTOLETTEN ^MERCK^</medicinalproduct>
        <drugdosagetext>1000 UG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522442-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0410106704</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 50/50</medicinalproduct>
        <drugdosagetext>50 U/1 DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522443-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004AR16470</companynumb>
    <primarysource>
      <qualification>1</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>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE VS PLACEBO</medicinalproduct>
        <drugdosagetext>5 MG, ONCE YEARLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE VS PLACEBO</medicinalproduct>
        <drugdosagetext>DOUBLE BLIND</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522444-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413304GDS</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522445-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041080712</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPOSURE TO TOXIC AGENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCRATCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522446-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410649BYL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugdosagetext>100 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAMEZIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522448-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0406103918</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96</patientweight>
      <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>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG/1 DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522449-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413019GDS</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522451-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108166</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugbatchnumb>7EC58B</drugbatchnumb>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522452-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200411133BVD</companynumb>
    <primarysource></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>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21277</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21277</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACC LONG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXIGRUEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522453-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0410106629</companynumb>
    <primarysource>
      <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>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugbatchnumb>7EFO2B</drugbatchnumb>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522455-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410854BVD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>19537</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030727</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522456-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041079860</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF MUTILATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>80 MG DAY</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522458-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040979206</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>80 MG DAY</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040329</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522460-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108332</companynumb>
    <primarysource>
      <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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURODERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROFIBROMATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>25 MG DAY</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZADONE (TRAZODONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522461-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200420962BWH</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94.8018</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIZORAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN (NO-FLUSH)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENERIC ^HEALTH FOOD^ CHOLESTEROL REDUCING PILL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TINEA CREAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDURACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEROVITAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522463-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040774135</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ACID PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>60 MG/ 1 DAY</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522464-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040978073</companynumb>
    <primarysource>
      <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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522466-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040259662</companynumb>
    <primarysource></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>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR (BENICAR)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522467-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184475</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF4M78B</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522468-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184481</companynumb>
    <primarysource>
      <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>HEPATITIS ALCOHOLIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522469-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA030537110</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF2M22A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIACTV</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522470-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA031151722</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522471-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040977655</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF4D74A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG/ 1 DAY</drugdosagetext>
        <drugindication>BONE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522472-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200420936BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.5442</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABYRINTHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522473-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041080326</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APRESOLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZIDE (GLICLAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT (ERYTHROPOIETIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522474-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200420295BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522475-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041082175</companynumb>
    <primarysource>
      <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>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522476-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KII-2004-0014114</companynumb>
    <primarysource>
      <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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OTHER HYPNOTICS AND SEDATIVES()</medicinalproduct>
        <drugdosagetext>SEE TEXT, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIEPILEPTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTINEOPLASTIC AGENTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINES FOR SYSTEMIC USE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID W/PROPOXYPHENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIINFLAMMATORY / ANTIRHEUMATIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522477-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108149</companynumb>
    <primarysource>
      <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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE URINE PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522478-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_040979531</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERELAN PM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522479-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KII-2004-0014145</companynumb>
    <primarysource>
      <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>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYSUBSTANCE ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEROIN (DIAMORPHINE)</medicinalproduct>
        <drugdosagetext>INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANNABIS (CANNABIS)</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522480-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040363175</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS SCLEROSING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>90 MG DAY</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522481-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415427BCC</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.5651</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>294094K</drugbatchnumb>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>440 MG, HS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FRACTURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522482-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0410107086</companynumb>
    <primarysource>
      <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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESIPRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASENDIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCALIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522483-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0410107342</companynumb>
    <primarysource>
      <qualification>1</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF4G15A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACOTNE (SPIRONOLACTONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522484-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108386</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522485-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411107926</companynumb>
    <primarysource>
      <qualification>1</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>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOMYOLIPOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN RENAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA OF LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACAL + D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522487-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108616</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PRERENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BETA HAEMOLYTIC STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE PEAKED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIC HYPEROSMOLAR NONKETOTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE KETONE BODY PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG DAY</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZTROPINE MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522488-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108085</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE OF IMPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040805</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522489-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184605</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF4G16C</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522490-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411107991</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOTAL LUNG CAPACITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLU (INFLUENZA VACCINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522491-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108385</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522492-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041080203</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugdosagetext>24 UG/KG/HR</drugdosagetext>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOPHED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522493-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184281</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522494-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108378</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522495-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA030229531</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF1V20D</drugbatchnumb>
        <drugdosagetext>20 UG/DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE NAPSYLATE W/ ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTORETIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522496-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184426</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMPRISONMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MURDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>20 UG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>20 UG DAY</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522497-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184306</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED ACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDODONTIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522498-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA030227832</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugindication>BONE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF4K44A</drugbatchnumb>
        <drugdosagetext>20 UG DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040829</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522499-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184246</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522500-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040978799</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522501-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184085</companynumb>
    <primarysource>
      <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>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>100 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522502-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108689</companynumb>
    <primarysource>
      <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>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030928</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522503-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15632</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETAZIDINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>9 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>54720</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522504-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040714</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US07550</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIP BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>ONE TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040614</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522505-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184627</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522506-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184543</companynumb>
    <primarysource>
      <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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>80 MG DAY</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522507-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041105120</companynumb>
    <primarysource>
      <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANDAXIN (TOFISOPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESMIT (MEDAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522508-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184217</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>31</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>25 MG DAY</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522509-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184444</companynumb>
    <primarysource>
      <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>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF4M78A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522510-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108586</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>50 MG OTHER</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522511-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108303</companynumb>
    <primarysource>
      <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>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST GASTRIC SURGERY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522512-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108267</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>40 MG DAY</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522513-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108285</companynumb>
    <primarysource>
      <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>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICOLOGIC TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522514-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040362774</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE STINGING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF3X85A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTURY SENIOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRANBERRY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522515-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBS041115988</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522516-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU_041108207</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTIPSYCHOTIC DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522517-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099326</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDUCTION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECEREBRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>21267</drugauthorizationnumb>
        <drugdosagetext>400 MG (I D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL HCL</medicinalproduct>
        <drugdosagetext>240 MG (120 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522518-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108578</companynumb>
    <primarysource>
      <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>ADJUSTMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>300 MG OTHER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522519-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-2004-029644</companynumb>
    <primarysource>
      <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>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIANOPIA HETERONYMOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL PATHWAY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>19596</drugauthorizationnumb>
        <drugdosagetext>10 ML, 1 DOSE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>19596</drugauthorizationnumb>
        <drugdosagetext>10 ML, 1 DOSE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522520-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2004-030569</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLIGHTED OVUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522521-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004PK01653</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN GRAFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENOSYNOVITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOSTESIN ^ASTRA^</medicinalproduct>
        <drugbatchnumb>B FE 700</drugbatchnumb>
        <drugauthorizationnumb>18304</drugauthorizationnumb>
        <drugdosagetext>TOTAL DOSE LESS THAN 50 MG</drugdosagetext>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRI</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522522-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC041141322</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVACOR           (SIMVASTATIN RATIOPHARM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSICOMBI</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522523-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004PK01971</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PEYRONIE'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BELOC ZOK</medicinalproduct>
        <drugauthorizationnumb>19962</drugauthorizationnumb>
        <drugdosagetext>95 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522524-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC041040937</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF3H75AC</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVOR (LORAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEURSIL (URSODEOXYCHOLIC ACID)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522525-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE06639</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVERSION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>20 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522526-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE_040613731</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GANGLION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEHISCENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIMAGON-D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522527-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02895</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUILLAIN-BARRE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522528-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02811</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522529-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108576</companynumb>
    <primarysource>
      <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>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR AGITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>160 MG OTHER</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522530-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02812</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE  ALLEN + HANBURYS LTD</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522531-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02815</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522532-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02816</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>40 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMACOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522533-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBS041015823</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATOMOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522534-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MK200411-0269-1</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIRAY 350</medicinalproduct>
        <drugbatchnumb>4071133</drugbatchnumb>
        <drugauthorizationnumb>19710</drugauthorizationnumb>
        <drugdosagetext>SINGLE USE</drugdosagetext>
        <drugindication>ARTERIOGRAM CORONARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522535-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC040940696</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>21</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATOMOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>25 MG/ 1 DAY</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522536-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12776621</companynumb>
    <primarysource>
      <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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSTHYMIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522537-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05302</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN E DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTAMINE LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugauthorizationnumb>20441</drugauthorizationnumb>
        <drugdosagetext>800 UG DAILY IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCOLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTENSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCONSAN K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEROTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOKUNALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUVOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILECE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASCON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLIOPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522538-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12776605</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>120</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AXEPIM INJ 500 MG</medicinalproduct>
        <drugdosagetext>2 GRAMS DAILY ON 12-OCT-2004, INTERRUPTED FROM 13- TO 15-OCT-2004</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESIDRIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522539-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12779120</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugdosagetext>29-JUL-2004 TO 23-SEP-2004</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>29-JUL-2004 TO 23-SEP-2004</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOPROL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXEN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUDECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPHREN</medicinalproduct>
        <drugdosagetext>2 MG/ML/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZANTAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522540-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02823</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522541-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BRISTOL-MYERS SQUIBB COMPANY-12785903</companynumb>
    <primarysource>
      <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>MENINGITIS MENINGOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN + HCTZ</medicinalproduct>
        <drugdosagetext>169 MG + 12.5 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEFLAZACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522542-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC041141570</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>803</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPLASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEGOFER      (FERRIPROTINATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRUM              (FERROUS FUMARTE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILICINE                (FOLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TROPHICARD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522543-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02382</companynumb>
    <primarysource>
      <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>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522544-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_041105285</companynumb>
    <primarysource>
      <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>CATATONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAROXYL            (AMITRIPYLINE HYDROCHLORIDE0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX                      (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTORETIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INIPOMP (PANTOPRAZOLE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522545-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02373</companynumb>
    <primarysource>
      <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522546-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041105248</companynumb>
    <primarysource>
      <qualification>1</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>ABULIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>20 MG DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTANE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522547-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC041141504</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG/2 DAY</drugdosagetext>
        <drugindication>ALCOHOLIC PSYCHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522548-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>22001122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE_041114747</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>5</patientweight>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522549-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_040202669</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA, PARANOID TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>5 MG/1 DAY</drugdosagetext>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TASMOLIN (BIPERIDEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON (SODIUM PICOSULFATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522550-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_040904844</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>20 MG/1 DAY</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20 MG/1 DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERCIAN (CYAMEMAZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE (ZOPICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSANXIA (PRAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUBUTEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORLAX (MACROGOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522551-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_040403838</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASPHYXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIET REFUSAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENDELSON'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>20 MG/1 DAY</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>10 MG/1 OTHER</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040322</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUPENTIXOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522552-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_031102170</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/OTHER</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030820</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522553-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE_041014400</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYSIPELOID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCESSIVE GRANULATION TISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTOLOGY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CONSOLIDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHANGIOSIS CARCINOMATOSA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-SMALL CELL LUNG CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWEAT GLAND DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>2000 MG</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEMASTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERGENTAN (ALIZAPRIDE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEXANE (ENOXAPRARIN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZUMETOP (METOPROLOL TARTRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONDRONAT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522554-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>800191</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.7</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>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUCINE AMINOPEPTIDASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>NA01</drugbatchnumb>
        <drugauthorizationnumb>21321</drugauthorizationnumb>
        <drugdosagetext>1.5 L; QD; INTRAPERITONEAL</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APRESOLNE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALOBEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTECADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENIVACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENFILL R</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522555-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_040804559</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-THYROXINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522556-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_040703979</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>18 U DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENFILL 30R (INSULIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITOROL (ISOSORBIDE MONONTRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYASPIRIN (ACETYLSALICYLIC AICD)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART (NICORANDIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOCHOL (FLUVASTATIN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOBAY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRENOXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522557-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBS041115871</companynumb>
    <primarysource>
      <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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOTHIEPIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE (ZOPICLONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522558-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC040840381</companynumb>
    <primarysource>
      <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>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC INFLAMMATORY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG DAY</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522559-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041105061</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>20 MG DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522560-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE_040313182</companynumb>
    <primarysource>
      <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>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG DAY</drugdosagetext>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522561-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004241727JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>22.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLAST CELLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE MORPHOLOGY ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>20280</drugauthorizationnumb>
        <drugdosagetext>0.7 MG (DAILY), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRADER-WILLI SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021127</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522562-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100103</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.4723</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>150 MG (150 MG, EVERY 10-13 WEEKS, 1ST INJECTION), INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MENORRHAGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522563-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004091479</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522564-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100524</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>99</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 - 400MG (2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG (75 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>30 MG (30 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NULYTELY (MACROGOL, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPIRIDE (SULPIRIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE (CODEINE PHOSPHATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDRONEL PMO ^NORWICH EATON^ (CALCIUM CARBONATE, ETIDRONATE DISODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEFOPAM HYDROCHLORIDE (NEFOPAM HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA (SENNA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSVASIN (BENZOCAINE, ETHYL NICOTINATE, HEXYL NICOTINATE, THURYFYL S</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE (DOMPERIDONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522565-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108580</companynumb>
    <primarysource>
      <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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>60 MG; OTHER</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERPHENAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522566-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC041141492</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>39</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN</medicinalproduct>
        <drugauthorizationnumb>19640</drugauthorizationnumb>
        <drugdosagetext>0.032 MG/6 WEEK</drugdosagetext>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522567-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041105202</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugauthorizationnumb>14103</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRARUBICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-ASPARAGINASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522568-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041105200</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE SYSTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOANING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SHOCK SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugauthorizationnumb>14103</drugauthorizationnumb>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522569-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04443</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522570-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040819</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004CA11773</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXAPINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522571-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041105203</companynumb>
    <primarysource>
      <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>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugauthorizationnumb>14103</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-ASPARAGINASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522572-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBS041115995</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFACLOR</medicinalproduct>
        <drugauthorizationnumb>50521</drugauthorizationnumb>
        <drugdosagetext>50 ML</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522573-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041004753</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFUSE LARGE B-CELL LYMPHOMA STAGE III</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugauthorizationnumb>14103</drugauthorizationnumb>
        <drugdosagetext>1.5 MG; OTHER</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PINORUBIN (PIRARUBICIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER (FAMOTIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN R (STREPTOCOCCUS FAECALIS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISODINE (POVIDONE-IODINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522574-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030821</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2003US08928</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-CARDIOGENIC PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BASILIXIMAB</medicinalproduct>
        <drugbatchnumb>029-G5166,NDC 0078-0331-84</drugbatchnumb>
        <drugdosagetext>12 MG/M2, ONCE/SINGLE</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>.15 MG/KG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>.5 MG/KG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522575-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004037687</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAMMONAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASMAPHERESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPIL FIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>19949</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIP/TAZO (PIPERACILLIN SODIUM, TAZOBACTAM SODIUM)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB (RITUXIMAB)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPTACOG ALFA (EPTACOG ALFA)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMINO ACIDS (AMINO ACIDS)</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN INTRAVENOUS (HUMAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAVULIN (AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522576-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030821</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2003US08927</companynumb>
    <primarysource>
      <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>CYANOSIS CENTRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-CARDIOGENIC PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BASILIXIMAB</medicinalproduct>
        <drugbatchnumb>029-G5166,NDC 0078-0331-84</drugbatchnumb>
        <drugdosagetext>12 MG/M2, ONCE/SINGLE</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>.15 MG/KG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>.5 MG/KG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522577-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099901</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>(1 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIANSERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPAFENONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALVERINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522578-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_041105296</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>20 MG/1 DAY</drugdosagetext>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL (BROMAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522579-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099032</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG 1 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031116</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522580-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099641</companynumb>
    <primarysource>
      <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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZARONTIN SYRUP</medicinalproduct>
        <drugauthorizationnumb>80258</drugauthorizationnumb>
        <drugdosagetext>(3 IN 1 D)</drugdosagetext>
        <drugindication>MYOCLONIC EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522581-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_041105270</companynumb>
    <primarysource>
      <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>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>10 MG/1 DAY</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JOSIR (TAMSULOSIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522582-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099460</companynumb>
    <primarysource>
      <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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FELDENE</medicinalproduct>
        <drugauthorizationnumb>18147</drugauthorizationnumb>
        <drugdosagetext>1 DOSE FORM DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHLEBITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040919</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522583-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBS041116027</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>7.5 MG/1 DAY</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522584-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099077</companynumb>
    <primarysource>
      <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>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (1 IN 1 D)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522585-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBS041115987</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3</patientweight>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEEDING PROBLEM IN NEWBORN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522586-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004082689</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (1 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>200 MG (1 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100 MG (1 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5 MG (1 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTRACARDIAC THROMBUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM POLYSTYRENE SULFONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522587-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC041141491</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REBOUND EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>25 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTITABS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMADRAX (AMOXICILLIN TRIHYDRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUXAL (CHLORPROTHIXENE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522588-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098617</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522589-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_041105230</companynumb>
    <primarysource>
      <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>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>15 MG/1 DAY</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERCIAN (CYAMEMAZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522590-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004092578</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRIDOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCOROTISONE SODIUM SUCCINATE (HYDROCORTISONE SODIUM SUCCINATE)</medicinalproduct>
        <drugauthorizationnumb>9866</drugauthorizationnumb>
        <drugdosagetext>200 MG (1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522591-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108594</companynumb>
    <primarysource>
      <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 TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>200 MG OTHER</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522592-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004084708</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDURA XL</medicinalproduct>
        <drugauthorizationnumb>19668</drugauthorizationnumb>
        <drugdosagetext>4 MG (4 MG, 1 IN 1), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN (METFORMIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522593-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003176595DE</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVODOPA (LEVODOPA)</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D (CALCIUM PHOSPHATE, CALCIUM  SODIUM LACTATE, ER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522594-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004079258</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDENALIN (DOXAZOSIN)</medicinalproduct>
        <drugauthorizationnumb>19668</drugauthorizationnumb>
        <drugdosagetext>5 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>100 MG, ONCE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugdosagetext>4 ML (4 ML, ONCE), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugdosagetext>INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYGEN (OXYGEN)</medicinalproduct>
        <drugdosagetext>INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETILEFRINE HYDROCHLORIDE (ETILEFRINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE (PHENYLEPHRINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VECURONIUM (VECURONIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522595-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBS041115967</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522596-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004095271</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
        <drugauthorizationnumb>20287</drugauthorizationnumb>
        <drugdosagetext>5000 I.U.</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522597-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_041105281</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERGOLIDE MESYLATE</medicinalproduct>
        <drugauthorizationnumb>19385</drugauthorizationnumb>
        <drugdosagetext>3 MG DAY</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODOPAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522598-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1000682</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESUSCITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INOMAX</medicinalproduct>
        <drugbatchnumb>PA-04-0210-2</drugbatchnumb>
        <drugdosagetext>80 PPM;CONT;INH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>VASODILATION PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VECURONIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINGER'S</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522599-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC041141522</companynumb>
    <primarysource>
      <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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERMAX</medicinalproduct>
        <drugauthorizationnumb>19385</drugauthorizationnumb>
        <drugdosagetext>3 MG</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLCAPONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPARK QUICK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIFROL (PRAMIPEXOLE DIHYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMOCONCOR (BISOPROLOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET DEPOT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522600-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099636</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugauthorizationnumb>19835</drugauthorizationnumb>
        <drugindication>PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PRURITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PRURITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522601-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100049</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>10 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>80 MG</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522602-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004079148</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>11111</drugauthorizationnumb>
        <drugdosagetext>25 MG (25 MG, 1 IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANGIOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROPERIDOL</medicinalproduct>
        <drugdosagetext>5 MG (5 MG, 1IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANGIOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIOPENTAL (TIOPENTAL)</medicinalproduct>
        <drugdosagetext>EPIDURAL</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VECURONIUM (VECURONIUM)</medicinalproduct>
        <drugdosagetext>EPIDURAL</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPHEDRINE HYDROCHLORIDE (EPHEDRINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOSTIGMINE (NEOSTIGMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPIVACAINE (ROPIVACAINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE (DOPAMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DINOPROST (DINOPROST)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHLORIDE (CALCIUM CHLORIDE ANHYDROUS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522603-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004075203</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PELVIC VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>600 MG (300 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>5 MG (1D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>40 DROP (20 DROP, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugdosagetext>4 MG (2 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522604-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004048216</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR RETARDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>900 MG (300 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040325</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522605-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004081439</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLLAGEN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZARONTIN (ETHOSUXIMIDE)</medicinalproduct>
        <drugauthorizationnumb>80258</drugauthorizationnumb>
        <drugdosagetext>12 CC, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>1200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOBAZAM (CLOBAZAM)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522606-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099437</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RELPAX</medicinalproduct>
        <drugauthorizationnumb>21016</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 GRAM, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040426</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522607-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098646</companynumb>
    <primarysource>
      <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>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRIBEDIL  (PIRIBEDIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKGO BILOBA EXTRACT (GINKGO BILOBA EXTRACT)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522608-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098654</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522609-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_041105256</companynumb>
    <primarysource>
      <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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>26 IU DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugdosagetext>44 IU DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522610-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099317</companynumb>
    <primarysource>
      <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>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugauthorizationnumb>9987</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN (WARFARIN)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN (LOSARTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522611-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>K200400604</companynumb>
    <primarysource>
      <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>BLOOD FOLATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>19901</drugauthorizationnumb>
        <drugdosagetext>1.25  MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOLIPRANE (PARACETAMOL) TABLET, 1,000MG</medicinalproduct>
        <drugdosagetext>1,000 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATHYMIL (MIANSERIN HYDROCHLORIDE) TABLET, 30MG</medicinalproduct>
        <drugdosagetext>30 MG , QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOTALEX (SOTALOL HYDROCHLORIDE) TABLET, 80 MG</medicinalproduct>
        <drugdosagetext>80 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECAPETYL (TRIPTORELIN ACETATE)</medicinalproduct>
        <drugdosagetext>3 MG, EVERY MONTH, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASASANTIN (DIPYRIDAMOLE, ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL (TRIMETAZIDINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRINIPATCH (GLYCERYL TRINITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE(SALMETEROL XINAFOATE, FLUTICASONE PROPIONATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522612-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_041105221</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OROCAL (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UN-ALFA (ALFACALCIDOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522613-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1429</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARATYNE (LORATADINE) TABLETS</medicinalproduct>
        <drugauthorizationnumb>19658</drugauthorizationnumb>
        <drugdosagetext>1 QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522614-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_040904860</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522615-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12975</companynumb>
    <primarysource>
      <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>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIVIRALS FOR SYSTEMIC USE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>800 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522616-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC041141575</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENINGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD COMPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugauthorizationnumb>19640</drugauthorizationnumb>
        <drugdosagetext>0.2 MG</drugdosagetext>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE (OMEPRAZOLE RATIOPHARM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLIXONASE (FLUTICASONE PROPIONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522617-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041205</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JO16393</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522618-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_040904862</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522619-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB03886</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM ^JANSSEN^</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522620-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041105006</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTIBODY TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEGAKARYOCYTES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugauthorizationnumb>19640</drugauthorizationnumb>
        <drugdosagetext>9.3 MG WEEK</drugdosagetext>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522621-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_040804323</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE MB INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SICK SINUS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN T INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERMAX</medicinalproduct>
        <drugauthorizationnumb>19385</drugauthorizationnumb>
        <drugdosagetext>1000 UG DAY</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARILODEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA AND LEVODOPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMMETREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX (TEPRENONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522622-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108584</companynumb>
    <primarysource>
      <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>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ETHANOL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>80 MG OTHER</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522623-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041004922</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTI-HBC IGM ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS A ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERMAX</medicinalproduct>
        <drugauthorizationnumb>19385</drugauthorizationnumb>
        <drugdosagetext>50 UG DAY</drugdosagetext>
        <drugindication>CEREBRAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENESIT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522624-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC041041132</companynumb>
    <primarysource>
      <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>ENCEPHALITIS VIRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugauthorizationnumb>19640</drugauthorizationnumb>
        <drugdosagetext>0.3 MG DAY</drugdosagetext>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTIROX (LEVOTHYROXINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOVIRON (TESTOSTERONE ENANTATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINIRIN (DESMOPRESSIN ACETATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522625-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE_041014524</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YENTREVE (DULOXETINE HYDROHCLORIDE)</medicinalproduct>
        <drugbatchnumb>A070188</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>40 MG DAY</drugdosagetext>
        <drugindication>STRESS INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDICANT - SLOW RELEASE (NIFEDIPINE PA)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522626-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE_041114741</companynumb>
    <primarysource>
      <qualification>1</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>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YENTREVE (DULOXETINE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 25</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HCP (METOCLOPRAMIDE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522627-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040323</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004AU04534</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>150</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040321</drugenddate>
        <drugtreatmentduration>397</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522628-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004FR15637</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH VESICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMATOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
        <drugtreatmentduration>50400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522629-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBS041015677</companynumb>
    <primarysource>
      <qualification>3</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>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANASAL SINUS HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugdosagetext>24 UG/KG/HR</drugdosagetext>
        <drugindication>SEPSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORADRENALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPEXAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFENTANIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID (INSULIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522630-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041105252</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMACART-HUMAN NPH INSULIN (RDNA) (HUMAN INSULIN (R</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>28 U AT BEDTIME</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOUGHMAC E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522632-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EM2004-0567</companynumb>
    <primarysource>
      <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>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA (INTERFERON ALFA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (CORTICOSTEROIDS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522633-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC041141482</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRAIN STEM HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAVENTRICULAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KAOLIN CEPHALIN CLOTTING TIME SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILS UNEQUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RUPTURED CEREBRAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugbatchnumb>Z33594</drugbatchnumb>
        <drugdosagetext>24 UG/KG/HR</drugdosagetext>
        <drugindication>SEPTIC SHOCK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORADRENALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN ELIXIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOL (OMEPRAZOLE RATIOPHARM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522635-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EM2004-0587</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA (INTERFERON ALFA)</medicinalproduct>
        <drugdosagetext>18 MIU, SUBCUTAN.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522636-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBS041115991</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>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522637-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP06092</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>19726</drugauthorizationnumb>
        <drugdosagetext>3.6 MG Q4WK SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ODYNE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522638-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE06568</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLENDIL</medicinalproduct>
        <drugauthorizationnumb>19834</drugauthorizationnumb>
        <drugdosagetext>5 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOPTEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOKREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALAZOPYRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522639-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBS041115990</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IATROGENIC INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522640-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05081</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugdosagetext>20 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522641-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA_041107476</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugindication>SEPSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOPRESSORS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522642-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE06625</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIAS</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522643-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-0003</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HYPERMOTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHLORHYDRIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGLYCEM</medicinalproduct>
        <drugauthorizationnumb>17425</drugauthorizationnumb>
        <drugdosagetext>150 MG QD</drugdosagetext>
        <drugindication>HYPOGLYCAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522644-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02219</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugdosagetext>8 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADANCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522645-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-0006</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TALIPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VACCINE EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QVAR 40</medicinalproduct>
        <drugauthorizationnumb>20911</drugauthorizationnumb>
        <drugdosagetext>INTERMITTENTL</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>INTERMITTENTL</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLUENZA VIRUS VACCINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRON SULFATETHIAMIN COMPOUND TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERMETHRIN</medicinalproduct>
        <drugdosagetext>TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030916</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522646-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05300</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>19627</drugauthorizationnumb>
        <drugdosagetext>100 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugdosagetext>50 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugdosagetext>25 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCCINYLCHOLINE CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERENAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIRCANETTEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRIC CITRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522647-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>K200401824</companynumb>
    <primarysource>
      <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>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>19901</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522648-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02346</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugdosagetext>40 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALEORID</medicinalproduct>
        <drugdosagetext>1000 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOTELON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STABLON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIPARINE ^DIFREX^</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522650-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02808</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>100 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522651-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004PK02024</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>900 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522653-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE06147</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>600 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBUTEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUXAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BURONIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522654-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02368</companynumb>
    <primarysource>
      <qualification>1</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHIOLOALVEOLAR CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>250 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHIOLOALVEOLAR CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE DISKUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRONCHODUAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522656-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004PK01782</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENPROCOUMON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522658-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP03488</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHIOLOALVEOLAR CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARNAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVISHOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522661-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05999</companynumb>
    <primarysource>
      <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>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugauthorizationnumb>20498</drugauthorizationnumb>
        <drugdosagetext>80 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugdosagetext>10.8 MG Q3MO SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522662-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE06603</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>12</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugauthorizationnumb>20929</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRICANYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522664-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02342</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugauthorizationnumb>20929</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>1 G BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugdosagetext>1 G QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522666-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041105201</companynumb>
    <primarysource>
      <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>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD HYPOSMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD OSMOLARITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OSMOLARITY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE SODIUM INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522667-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041105199</companynumb>
    <primarysource>
      <qualification>3</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>CHOLANGITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS SUPPURATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1000 MG OTHER</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030828</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522668-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ABBOTT-04P-144-0281650-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DESQUAMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOFRON UNIDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTH DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522669-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040824</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0271428-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.16</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISOMY 18</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZT</medicinalproduct>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522670-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_040904602</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1400 MG OTHER</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522671-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040902</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-04P-087-0272613-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040902</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040902</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522672-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-04P-062-0280210-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE W/LAMIVUDINE</medicinalproduct>
        <drugdosagetext>150/300MG X 2</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIMETHAMINE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM FOLINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522673-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE_041114728</companynumb>
    <primarysource>
      <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>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIEMETICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522674-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0281773-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BETA HAEMOLYTIC STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIC RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPROBASE CREAM</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>NARAD B.P</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBOGEL</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>4522676-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ABBOTT-04P-151-0281647-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEGACOLON ACQUIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EXTRAPYRAMIDAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE</medicinalproduct>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522677-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0281811-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.904</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>E.E.S. 400</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
      </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>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522678-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-04P-087-0282134-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040214</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040214</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN TRIHYDRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040214</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522679-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBS041115983</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIEMETICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522680-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-04P-020-0280480-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>LOPINAVIR 799.8 MG AND RITONAVIR 199.8 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522682-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0264698-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522683-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02334</companynumb>
    <primarysource>
      <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>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCAINE</medicinalproduct>
        <drugauthorizationnumb>71202</drugauthorizationnumb>
        <drugdosagetext>13.5 MG ONCE IT</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>SPINAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPNOVEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522684-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031211</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-03P-163-0245195-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031118</drugenddate>
        <drugtreatmentduration>155</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELAVIRDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031118</drugenddate>
        <drugtreatmentduration>155</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031118</drugenddate>
        <drugtreatmentduration>155</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522685-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0282165-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBUSE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE MEDICATIONS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522686-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBT040801531</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE-IV (GEMCITABINE)</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2/2 OTHER</drugdosagetext>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522687-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE06599</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugauthorizationnumb>20929</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522689-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE_041114732</companynumb>
    <primarysource>
      <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>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YENTREVE (DULOXETINE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>40 MG/2 DAY</drugdosagetext>
        <drugindication>STRESS INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YENTREVE (DULOXETINE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>40 MG/2 DAY</drugdosagetext>
        <drugindication>URINARY INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522690-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>20041100492</companynumb>
    <primarysource></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>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUTURE RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUPRANE</medicinalproduct>
        <drugauthorizationnumb>20118</drugauthorizationnumb>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUPRANE</medicinalproduct>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522692-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_041105272</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PROCEDURE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOBUTREX</medicinalproduct>
        <drugauthorizationnumb>17820</drugauthorizationnumb>
        <drugindication>CARDIOVASCULAR EVALUATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDIATOR (BENFLUOREX HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERMION (NICERGOLINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522693-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NUBN20040025</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>20</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE BONE MARROW APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUBAIN</medicinalproduct>
        <drugauthorizationnumb>18024</drugauthorizationnumb>
        <drugdosagetext>24 MG DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE LYOPHILISATE</medicinalproduct>
        <drugdosagetext>2.65 G DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugdosagetext>450 MG DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOCILLINE        (PIPERACILLIN/TAZOBACTAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKILIN (AMIKACIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522695-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004-1814</companynumb>
    <primarysource>
      <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>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugauthorizationnumb>74478</drugauthorizationnumb>
        <drugdosagetext>10 MG ON ALL OCCASIONS</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugindication>AGORAPHOBIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522696-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBS041115965</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>20 MG/2 DAY</drugdosagetext>
        <drugindication>STRESS INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522697-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE_041114752</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL FAECES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YENTREVE (DULOXETINE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>40 MG IN THE EVENING</drugdosagetext>
        <drugindication>INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041017</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522699-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004-1813</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugauthorizationnumb>74478</drugauthorizationnumb>
        <drugdosagetext>10 MG (2 DOSES) IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugdosagetext>150MG O.M. + 75MG O.N.</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522700-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBT041101796</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>1000 MG/1 OTHER</drugdosagetext>
        <drugindication>MESOTHELIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>150 MG/1 OTHER</drugdosagetext>
        <drugindication>MESOTHELIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAMORPH SR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-DANTHRAMER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</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>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522702-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004-1815</companynumb>
    <primarysource>
      <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>DUODENAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugauthorizationnumb>74376</drugauthorizationnumb>
        <drugdosagetext>50 MG TDS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPPERMINT OIL MENTHA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL AND CHLORTHALIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL-CODEINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522703-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC041141580</companynumb>
    <primarysource>
      <qualification>1</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>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522704-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004-1812</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugauthorizationnumb>70302</drugauthorizationnumb>
        <drugdosagetext>4 MG DAILY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE 100MG</medicinalproduct>
        <drugdosagetext>100MG DAILY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>70 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBULISED SALBUTAMOL AND IPRATROPIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522706-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041004923</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugbatchnumb>E0569DA</drugbatchnumb>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JEOASE (PROTEASE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPEN (ETODOLAC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASLON (IRSOGLADINE MALEATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMOTONIN (CALCITONIN, SALMON)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522707-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_041105235</companynumb>
    <primarysource>
      <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>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTRIGLYCERIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG DAY</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522708-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_040904845</companynumb>
    <primarysource>
      <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>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG DAY</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522709-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041004810</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONALON (ALENDRONIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS (ETIZOLAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522711-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_041105245</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>20 MG/1 DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERCIAN (CYAMEMAZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAONIL FAIBLE (GLIBENCLAMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEFIZAL (BEZAFIBRATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522712-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041004700</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEN (IPRIFLAVONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL (ALFACALCIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA-CA (ASPARTATE CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELCATONIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522713-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_041105257</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG/1 DAY</drugdosagetext>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSANXIA (PRAZEPAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522715-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_041105271</companynumb>
    <primarysource>
      <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>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXEN (NIMESULIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYZALL (LEVOCETIRIZINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522716-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_040904551</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 IN THE MORNING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS (CANDESARTAN CELEXETIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAYBAN (FLURBIPROFEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRENOXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX (TEPRENONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522719-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041004712</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCORNAL (TRAPIDIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX (TEPRENONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHIPNOL (FLUNITRAZEPAM EG)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN (MOSAPRIDE CITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOSIN (PANTETHINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONALON (ALENDRONIC ACID)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522721-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC041141447</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IDEOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT MITE TURBUHALER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASONASE (NICARDIPINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522723-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBT040701514</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERIPARATIDE</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG/ 1DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC (OMEPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-DYDRAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW D3 FORTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522724-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004011652</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>19949</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN (CLINDAMYCIN)</medicinalproduct>
        <drugdosagetext>2.4 GRAM (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031231</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFADIAZINE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFADIAZINE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRIMETHAMINE TAB</medicinalproduct>
        <drugdosagetext>50 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN W/CLAVULANATE POTASSIUM (AMOXICILLIN W/CLAVULANATE POTASSI</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFUROXIME</medicinalproduct>
        <drugdosagetext>1 GRAM (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040113</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522726-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003155701DE</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE HEART DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>2 MG (DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRIMARY HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522728-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100041</companynumb>
    <primarysource>
      <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>CATATONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED SELF-CARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SENILE DEMENTIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE (PANTOPRAZOLE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522729-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100162</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>171</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL VARICES HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOOCCLUSIVE LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>20571</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATIN)</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB (CETUXIMAB)</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040824</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522731-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RS004563-GB</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIATUS HERNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE (THIAMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINIMS ARTIFICIAL TEARS (HYDROXYETHYLCELLULOSE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE (LEVOTHYROXINE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZYLPENICILLIN (BENZYLPENICILLIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCLOAXICILLIN (FLUCLOAXICILLIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522732-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE254024NOV03</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADENOCARCINOMA OF THE CERVIX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVIX CARCINOMA STAGE II</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE, CONTROL FOR SIROLIMUS (CYCLOSPORINE, CONTROL FOR SIROLIM</medicinalproduct>
        <drugauthorizationnumb>50738</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE, CONTROL FOR SIROLIMUS (CYCLOSPORINE, CONTROL FOR SIROLIM</medicinalproduct>
        <drugauthorizationnumb>50738</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN (SIMVASTTIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522733-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2004A04454</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>15 MG (15 MG, 1D), PER ORAL; AROUND</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
        <drugtreatmentduration>349</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522734-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2004A04480</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>15 MG (15 MG, 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522735-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ERD2004A00041</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HYDROCHLORIDE (PIOGLITAZONE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>BLIND, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
        <drugtreatmentduration>896</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOGIMAX (MODILOC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL (-ERINDORIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XATRAL (ALFUZOSIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC (ALLOPURINOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522736-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2003A02066</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN NATRIURETIC PEPTIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>15 MG (15 MG, 1 IN 1D), PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030425</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFORMIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHERYL NICOTINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSENN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA LEAF</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522737-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2004A01711</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</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>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030617</drugenddate>
        <drugtreatmentduration>103</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BASEN (VOGLIBOSE)</medicinalproduct>
        <drugdosagetext>0.4 MG (0.4 MG, 1 D), PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030617</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522738-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2004A03798</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>30 MG (30 MG, 1 IN 1 D) , PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
        <drugtreatmentduration>338</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOBAY</medicinalproduct>
        <drugdosagetext>300 MG (300 MG, 1 D), PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
        <drugtreatmentduration>366</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOSAPRIDE CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXATIDINE ACETATE HYDROCHLORIDE0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522739-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-122807-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugauthorizationnumb>18776</drugauthorizationnumb>
        <drugdosagetext>4 MG ONCE; ITNRAVNEOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000526</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOAM HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFENTANIL HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522741-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-113341-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DANAPAROID SODIUM</medicinalproduct>
        <drugauthorizationnumb>20430</drugauthorizationnumb>
        <drugdosagetext>2500 ANTI XA INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DISSEMINATED INTRAVASCULAR COAGULATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030304</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBENIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URINASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CABEXATE MESILATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE SODIUM SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELASPOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMNOGLOBULIN HUMAN NORMAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN HUMAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522743-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-113373-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD FIBRINOGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN D DIMER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN DEGRADATION PRODUCTS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBIN-ANTITHROMBIN III COMPLEX ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DANAPAROID SODIUM</medicinalproduct>
        <drugauthorizationnumb>20430</drugauthorizationnumb>
        <drugdosagetext>2500 ANTI XA  INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DISSEMINATED INTRAVASCULAR COAGULATION</drugindication>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URINASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABEXATE MESILATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIENAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAFAMOSTAT MESILATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTITHROMBIN III</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN HUMAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN INTRAVENOUS (HUMAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522744-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-122922-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522746-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-119788-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>30 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040716</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HYDROCHORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOMIPRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYAMEMAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLORAZEPATE DIPOTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPATAMINOL HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522747-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-122901-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>45 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHINYL ESTRADIOL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522749-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2004A00915</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE FEBRILE NEUTROPHILIC DERMATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>20406</drugauthorizationnumb>
        <drugdosagetext>15 MG (15 MG, 1 IN 1 D) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE (CETIRIZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXOCOBALAMIN (HYDROXOCOBALAMIN) (INJECTION)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522751-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>805#1#2004-00034</companynumb>
    <primarysource>
      <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>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROSTANDIN     (ALPROSTADIL    (PAOD)</medicinalproduct>
        <drugauthorizationnumb>20379</drugauthorizationnumb>
        <drugdosagetext>60 MCG INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUMBAR SPINAL STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522752-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A01200405179</companynumb>
    <primarysource>
      <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>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCULUS BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EROSIVE OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XATRAL                 (ALFUZOSIN)</medicinalproduct>
        <drugauthorizationnumb>21287</drugauthorizationnumb>
        <drugdosagetext>5 MG BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATIC ADENOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANDROCUR - (CYPROTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>2 UNIT BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522754-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099644</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYZINE HCL</medicinalproduct>
        <drugauthorizationnumb>10392</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOFEXIDINE (LOFEXIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN (DOXEPIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM HYDROXIDE (MAGNESIUM HYDROXIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522756-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A02200403066</companynumb>
    <primarysource>
      <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>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL VARICES HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELIOSIS HEPATIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOOCCLUSIVE LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>CUMULATIVE DOSE : 2680 MG</drugdosagetext>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040102</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>CUMULATIVE DOSE : 2680 MG</drugdosagetext>
        <drugindication>METASTASES TO LIVER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040102</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPTOSAR</medicinalproduct>
        <drugdosagetext>CUMULATIVE DOSE : 7575 MG</drugdosagetext>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040824</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPTOSAR</medicinalproduct>
        <drugdosagetext>CUMULATIVE DOSE : 7575 MG</drugdosagetext>
        <drugindication>METASTASES TO LIVER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040824</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX - (CETUXIMAB) - SOLUTION</medicinalproduct>
        <drugdosagetext>418 MG OTHER (CUMULATIVE DOSE : 8942 MG)</drugdosagetext>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040824</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX - (CETUXIMAB) - SOLUTION</medicinalproduct>
        <drugdosagetext>418 MG OTHER (CUMULATIVE DOSE : 8942 MG)</drugdosagetext>
        <drugindication>METASTASES TO LIVER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040824</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522757-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004070529</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LDL/HDL RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED CELL DISTRIBUTION WIDTH INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG (25 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE (BENDROFLUMETHIAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE (GLICLAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522759-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A01200405929</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROPS FOETALIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STILNOX          (ZOLPIDEM)</medicinalproduct>
        <drugauthorizationnumb>19908</drugauthorizationnumb>
        <drugdosagetext>10 MG, TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugdosagetext>20 MG TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522761-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-13083YA</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>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPANCREATIC FLUID COLLECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMIX                (TAMSULOSIN HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>20579</drugauthorizationnumb>
        <drugdosagetext>0.4 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040718</drugenddate>
        <drugtreatmentduration>826</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522762-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098100</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>2400 MG (800 MG, 3 IN 1 D)</drugdosagetext>
        <drugindication>POLYNEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOMIPRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYGEUM AFRICANUM (PYGEUM AFRICANUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOCARNITINE (LEVOCARNITINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522763-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12289BP</companynumb>
    <primarysource>
      <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>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>20636</drugauthorizationnumb>
        <drugdosagetext>(200 MG)</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE   (STAVUDINE)</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE    (LAMIVUDINE)</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522765-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SP-2004-001952</companynumb>
    <primarysource>
      <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>URTICARIA GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN</medicinalproduct>
        <drugauthorizationnumb>21286</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522766-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-UK-01258UK</companynumb>
    <primarysource>
      <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>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugdosagetext>18 MCG (18 MCG)  IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>........</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522768-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SP-2004-001949</companynumb>
    <primarysource>
      <qualification>1</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugauthorizationnumb>21286</drugauthorizationnumb>
        <drugdosagetext>40 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522769-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A02200403448</companynumb>
    <primarysource>
      <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>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAMYLASAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLACTACIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ALKALOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugauthorizationnumb>9768</drugauthorizationnumb>
        <drugdosagetext>400 MG,</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>12.5 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>50 MG  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT D3                  (CALCIUM/COLECALCIFEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522771-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SU-2004-002873</companynumb>
    <primarysource>
      <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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN</medicinalproduct>
        <drugauthorizationnumb>21286</drugauthorizationnumb>
        <drugdosagetext>40 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>40 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENNA LEAF</medicinalproduct>
        <drugdosagetext>36 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
        <drugdosagetext>37.5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIMAPROST</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522773-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F01200401577</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS RADIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>10 MG/M2 ON DAY 2, Q2W INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031015</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>1000 MG/M2 ON DAY 1, Q2W INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031113</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL (BROMAZEPAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522774-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZONI002075</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEGRAN (ZONISAMIDE)</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>100 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522775-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040329</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F01200400682</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS RADIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>10 MG/M2 ON DAY 2, Q2W INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031015</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR - (GEMCITABINE HYDROCHLORIDE)- 1000 MG/M2 / SOLUTION - 10 MG/M2</medicinalproduct>
        <drugdosagetext>1000 MG/M2 ON DAY 1, Q2W / 100 MG/M2 1/WEEK / 100 MG/M2 1/WEEK INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031113</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR - (GEMCITABINE HYDROCHLORIDE)- 1000 MG/M2 / SOLUTION - 10 MG/M2</medicinalproduct>
        <drugdosagetext>1000 MG/M2 ON DAY 1, Q2W / 100 MG/M2 1/WEEK / 100 MG/M2 1/WEEK INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040226</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR - (GEMCITABINE HYDROCHLORIDE)- 1000 MG/M2 / SOLUTION - 10 MG/M2</medicinalproduct>
        <drugdosagetext>1000 MG/M2 ON DAY 1, Q2W / 100 MG/M2 1/WEEK / 100 MG/M2 1/WEEK INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040304</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL (BROMAZEPAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522777-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F01200403678</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMAUROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>130 MG/M2 Q3W INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>1000 MG/M2 TWICE DAILY FOR 2 WEEKS, Q3W ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB OR PLACEBO - SOLUTION</medicinalproduct>
        <drugdosagetext>1 UNIT Q3W INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522778-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A01200405471</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugauthorizationnumb>19908</drugauthorizationnumb>
        <drugdosagetext>5-10 MG NOCTE</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANT NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE TABLET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522779-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F01200403680</companynumb>
    <primarysource>
      <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>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>100 MG/M2 ON DAY 2, Q2W INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>1000 MG/M2 ON DAY 1, Q2W INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522781-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A02200403450</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugauthorizationnumb>19908</drugauthorizationnumb>
        <drugdosagetext>10 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XATRAL - (ALFUZOSIN)</medicinalproduct>
        <drugdosagetext>5 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>160 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>750 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAFLON - (DIOSMIN)</medicinalproduct>
        <drugdosagetext>750 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugdosagetext>30 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugdosagetext>500 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522782-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040810</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0408USA00822</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOROXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOROXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANATON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANATON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EBRANTIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EBRANTIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISTIGMINE BROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISTIGMINE BROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMMETREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRORENAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHYPNOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALMATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522783-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00549</companynumb>
    <primarysource>
      <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>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522784-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00726</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DENTAL OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522786-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F02200400073</companynumb>
    <primarysource>
      <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>BLADDER DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS NONINFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XATRAL - (ALFUZOSIN) - TABLET PR - 10 MG</medicinalproduct>
        <drugauthorizationnumb>21287</drugauthorizationnumb>
        <drugdosagetext>10 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040517</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522787-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00690</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>119</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARSAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522788-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040908</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F02200400060</companynumb>
    <primarysource>
      <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>BLADDER DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XATRAL - (ALFUZOSIN)</medicinalproduct>
        <drugauthorizationnumb>21287</drugauthorizationnumb>
        <drugdosagetext>10 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040517</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522790-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZONI002067</companynumb>
    <primarysource>
      <qualification>3</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>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS PSEUDOMONAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAMMONAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEGRAN (ZONISAMIDE)</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugdosagetext>120 MG</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL (MECOBALAMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LONOXIN (LOXOPROFEN SODIUM0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEIACT (CEFDITOREN PIVOXIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEIACT(CEFDITOREN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACUATIM (NADIFLOXACIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS REISIPPU (COLD PACK)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522791-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A02200403478</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>20839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR ^MERCK^ - (MONTELUKAST SODIUM) - TABLET</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUPRESSYL (URAPIDIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OROCAL D3 (CALCIUM CARBONATE/COLECALCIFEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFAN (PARACETAMOL/CAFFEINE/DEXTROPROPOXYPHENE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOGALENE (METOPIMAZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT (BUDESONIDE/FORMOTEROL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522793-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZONI002057</companynumb>
    <primarysource>
      <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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MUCOSAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEGRAN (ZONISAMIDE)</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522794-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F01200401590</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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN - SOLUTION - 85 MG/M2</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>85 MG/M2 Q2W INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040524</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>400 MG/M2 IV BOLUS THEN 600 MG/M2 AS CONTINUOUS INFUSION ON D1-D2, Q2W INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>200 MG/M2 Q2W INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB - SOLUTION - 5 MG/KG</medicinalproduct>
        <drugdosagetext>5 MG/KG Q2W INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040524</drugenddate>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISOTHIAZIDE (HYDROCHLOROTHIAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522796-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-UKI-07826-01</companynumb>
    <primarysource>
      <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>ASPHYXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>60 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522797-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A02200403513</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATINE - (OXALIPLATIN) - POWDER - 5 MG/ML</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>150 MG OTHER INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040712</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>2000 MG OTHER INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040712</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522799-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-SWE-07600-01</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE CONTRACTIONS DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</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>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE DEPOT VENLAFAXINE0</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522800-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A02200403506</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>95</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STILNOX - (ZOLPIDEM) - TABLET - 10 MG</medicinalproduct>
        <drugauthorizationnumb>19908</drugauthorizationnumb>
        <drugdosagetext>10 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</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>VASTAREL (TRIMETAZIDINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522801-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-MERCK-0412CHN00010</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE MB INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <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>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522802-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BRO-007981</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL SPHINCTER ATONY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER SPHINCTER ATONY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IOPAMIDOL-300</medicinalproduct>
        <drugauthorizationnumb>18735</drugauthorizationnumb>
        <drugdosagetext>150 ML IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>807</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522803-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0412USA00586</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>FEMORAL NECK FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
        <drugtreatmentduration>387</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATLEP</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522804-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0411AUS00247</companynumb>
    <primarysource>
      <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>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NERVOUSNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522805-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA04187</companynumb>
    <primarysource>
      <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>INFUSION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE VESICLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLITA T-3</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOLAMIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522806-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BRO-007982</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IOPAMIDOL-300</medicinalproduct>
        <drugauthorizationnumb>18735</drugauthorizationnumb>
        <drugdosagetext>150 ML IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>807</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522807-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0412FRA00016</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>-14</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL AGENESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522808-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0412USA00585</companynumb>
    <primarysource>
      <qualification>1</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>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THORACIC VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010521</drugenddate>
        <drugtreatmentduration>263</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522809-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03017</companynumb>
    <primarysource>
      <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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARPAL TUNNEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTAZYM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522810-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00210</companynumb>
    <primarysource>
      <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>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020731</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522811-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NLWYE255103DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</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>75 MG 60X PER 1 TOT ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522812-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0407USA00560</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</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 CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020728</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522813-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00835</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLUE TOE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS PHARYNGEAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBULA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERMITTENT CLAUDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARSAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>1849</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESIC OR ANESTHETIC (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522814-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040318</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0403FRA00077</companynumb>
    <primarysource>
      <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>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CERVICAL ROOT PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040315</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040315</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040315</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040315</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522815-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PTWYE258405DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugbatchnumb>M43753</drugbatchnumb>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>75 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522816-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SEWYE255903DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>75 MG 1X PER 1 DAY ORAL; STARTED FOUR YEARS AGO; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522817-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE200115NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOCIN (PIPERACILLIN/TAZOBACTAM, INJECTION)</medicinalproduct>
        <drugauthorizationnumb>50684</drugauthorizationnumb>
        <drugdosagetext>3.6 G 3X PER 1 DAY INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CYSTIC FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030619</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CREON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE (BUDESONIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE (CETIRIZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLISTIN SULFATE (COLISTIN SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOBRAMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADEK-FALK (COLECALCIFEROL/MENADIOL DIACETATE/RETINOL PALMITATE/TOCOPHE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522819-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03735</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522820-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE692329NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOCIN (PIPERACILLIN/TAZOBACTAM, INJECTION)</medicinalproduct>
        <drugauthorizationnumb>50684</drugauthorizationnumb>
        <drugdosagetext>2.5 G 2X PER 1 DAY INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040906</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIPINE (NICARDIPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE SODIUM SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCATEROL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOPHYLLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANNITOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522821-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00750</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000410</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522822-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0410AUS00064</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN AND DIPYRIDAMOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522823-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA01014</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRODIURIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522824-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE972010JUL04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL MOTOR NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORY NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>200 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>400 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEPRONIZINE (ACEPROMETAZINE/MEPROBAMATE, )</medicinalproduct>
        <drugdosagetext>820 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>4 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE (THALIDOMIDE, )</medicinalproduct>
        <drugdosagetext>100 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE (THALIDOMIDE, )</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLECAINE (FLECAINIDE ACETATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522826-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE714601DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERNATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522827-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0412AUS00002</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522828-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE566222APR04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NILSTAT (NYSTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE SODIUM (LEVOTHYROXINE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522829-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE695529NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>150 MG 1X PER 1 DAY ORAL; 75 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGORAPHOBIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>150 MG 1X PER 1 DAY ORAL; 75 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>150 MG 1X PER 1 DAY ORAL; 75 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGORAPHOBIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>150 MG 1X PER 1 DAY ORAL; 75 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC (OMEPRAZOLE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522830-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03191</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </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>PAXIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLUENZA VIRUS VACCINE (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021107</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522831-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-MERCK-0412CHE00003</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040911</drugenddate>
        <drugtreatmentduration>561</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522832-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00438</companynumb>
    <primarysource>
      <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>AORTIC ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIANOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040903</drugenddate>
        <drugtreatmentduration>883</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
        <drugtreatmentduration>55</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040903</drugenddate>
        <drugtreatmentduration>883</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
        <drugtreatmentduration>55</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522833-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE693529NOV04</companynumb>
    <primarysource></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>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME SHORTENED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>200 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>95</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
        <drugdosagetext>3 MG TABLET ORAL ; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
        <drugdosagetext>3 MG TABLET ORAL ; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522834-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03215</companynumb>
    <primarysource>
      <qualification>1</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522835-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0412AUS00028</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522836-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03453</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522838-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A02200403504</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTIBODY TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS A</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROLOGY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KERLONE</medicinalproduct>
        <drugauthorizationnumb>75541</drugauthorizationnumb>
        <drugdosagetext>20 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>100 MCG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTAZINE - (SPIRONOLACTONE, ALTIZIDE) - TABLET - 25 MG</medicinalproduct>
        <drugdosagetext>12.5 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEXAQUINE - (QUININE, THIAMINE) - TABLET - 160 MG</medicinalproduct>
        <drugdosagetext>2 UNIT ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AERIUS (DESLORATADINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522840-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A02200403515</companynumb>
    <primarysource></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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KERLONE</medicinalproduct>
        <drugauthorizationnumb>75541</drugauthorizationnumb>
        <drugdosagetext>20 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>25 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON (GLICLAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSSOPAN (DURAPATITE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROSULF (CHONDROITIN SULFATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522842-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00414</companynumb>
    <primarysource>
      <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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRODIURIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIORIDAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522843-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>000#8#2004-00748</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugauthorizationnumb>87946</drugauthorizationnumb>
        <drugdosagetext>INTRACORONARY</drugdosagetext>
        <drugadministrationroute>022</drugadministrationroute>
        <drugindication>ARTERIOSPASM CORONARY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUMATRIPTAN (SUMATRIPTAN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522844-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00519</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522845-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0412CAN00021</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522846-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12191BP</companynumb>
    <primarysource></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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETALOC (METOPROLOL TARTRATE) (NR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASA (ACETYLSALICYLIC ACID) (NR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC (NR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRATES (NR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATINS (NR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B1, 6 +12 (NR)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522848-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00552</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVATAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522849-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003-104643-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPARIN-INDUCED THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DANAPAROID SODIUM</medicinalproduct>
        <drugauthorizationnumb>20430</drugauthorizationnumb>
        <drugdosagetext>7500 ANTI_XA/533 ANTI_XA Q1HR/1500 ANTI_XA ONCE/1500 ANTI_XA ONCE/760 ANTI_XA Q1HR INTRAVENOUS BOLUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANGINA UNSTABLE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DANAPAROID SODIUM</medicinalproduct>
        <drugauthorizationnumb>20430</drugauthorizationnumb>
        <drugdosagetext>7500 ANTI_XA/533 ANTI_XA Q1HR/1500 ANTI_XA ONCE/1500 ANTI_XA ONCE/760 ANTI_XA Q1HR INTRAVENOUS BOLUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
        <drugindication>ANGINA UNSTABLE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROTININ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522850-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00531</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522851-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00678</companynumb>
    <primarysource>
      <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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522852-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00683</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522853-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00373</companynumb>
    <primarysource>
      <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>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522854-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00548</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522855-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00555</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>KNEE OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522856-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>805#1#2004-00033</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROSTANDIN-I.V. (ALPROSTADIL (PAOD))</medicinalproduct>
        <drugauthorizationnumb>20379</drugauthorizationnumb>
        <drugdosagetext>43.3 MCG INTRAVENOUS DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PULMONARY VALVE STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040820</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522857-6</safetyreportid>
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    <transmissiondate>20050328</transmissiondate>
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      <qualification>5</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugindication>ARTHRITIS</drugindication>
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        <drugstartdate>20030101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522858-8</safetyreportid>
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    <transmissiondate>20050328</transmissiondate>
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    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00458</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522859-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00384</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEG AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522860-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00503</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522861-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-122943-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS INCOMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECTOPIC PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MENOTROPINS</medicinalproduct>
        <drugauthorizationnumb>20328</drugauthorizationnumb>
        <drugdosagetext>DF</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOMIPHENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522863-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00059</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522864-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00686</companynumb>
    <primarysource>
      <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522865-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00724</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522866-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>29702</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE MB INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOGYL</medicinalproduct>
        <drugauthorizationnumb>84108</drugauthorizationnumb>
        <drugdosagetext>OPHT</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>CYCLOPLEGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522867-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00674</companynumb>
    <primarysource>
      <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>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522868-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00651</companynumb>
    <primarysource>
      <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>ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522869-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00684</companynumb>
    <primarysource>
      <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>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522870-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00783</companynumb>
    <primarysource>
      <qualification>4</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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522871-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0412USA00765</companynumb>
    <primarysource>
      <qualification>1</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE RESPIRATORY DISTRESS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE RESPIRATORY DISTRESS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POLYURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522872-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F01200403407</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DIATHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIGARD</medicinalproduct>
        <drugauthorizationnumb>21379</drugauthorizationnumb>
        <drugdosagetext>22.5 MG, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040609</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522873-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BEI-003847</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOARSENESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROGRADE AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROHANCE</medicinalproduct>
        <drugauthorizationnumb>20131</drugauthorizationnumb>
        <drugdosagetext>12 ML, IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MASS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROHANCE</medicinalproduct>
        <drugauthorizationnumb>20131</drugauthorizationnumb>
        <drugdosagetext>12 ML, IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MUSCLE ATROPHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROHANCE</medicinalproduct>
        <drugauthorizationnumb>20131</drugauthorizationnumb>
        <drugdosagetext>12 ML, IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MUSCULAR WEAKNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROHANCE</medicinalproduct>
        <drugauthorizationnumb>20131</drugauthorizationnumb>
        <drugdosagetext>12 ML, IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031006</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522874-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BEI-004926</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL REFLEX DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH BREATHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADOTERIDOL/PROHANCE SYRINGE</medicinalproduct>
        <drugauthorizationnumb>20131</drugauthorizationnumb>
        <drugdosagetext>13 ML; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522875-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A02200403516</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEPRONIZINE- (MEPROBAMATE/ACEPROMETAZINE) - TABLET - 410 MG</medicinalproduct>
        <drugdosagetext>410 MG OD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MODECATE ^SANOFI WINTHROP^ - IFLUPHENAZINE DECANOTE)- SOLUTION</medicinalproduct>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTAN - (ETHYL LOFLAZEPATE)- TABLET - 2MG</medicinalproduct>
        <drugdosagetext>2 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STILNOX - (ZOLPIDEM) - TABLET- 10 MG</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKINE CHRONO - (VALPROATE SODIUM) - TABLET PR - 500 MG</medicinalproduct>
        <drugdosagetext>250 MG OD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522876-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-UKI-07892-01</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRALEX (ESCITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE ^APS^ (LEVOTHYROXINE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-AMILOFRUSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUMATRIPTAN SUCCINATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522877-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-MERCK-0411PRT00007</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EROSIVE DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040910</drugenddate>
        <drugtreatmentduration>93</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE AND LISINOPRIL</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>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040910</drugenddate>
        <drugtreatmentduration>367</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLORAZEPATE DIPOTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040910</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522878-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-SWE-07890-02</companynumb>
    <primarysource>
      <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>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL HIP DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR NEONATAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRALEX (ESCITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040911</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522879-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-YUG-07887-01</companynumb>
    <primarysource>
      <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>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522880-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-SWE-07890-01</companynumb>
    <primarysource>
      <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>PRE-ECLAMPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRALEX (ESCITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040911</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522881-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-SWE-07227-01</companynumb>
    <primarysource>
      <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>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAINFUL RESPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRALEX (ESCITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040810</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522882-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-DEN-07964-01</companynumb>
    <primarysource>
      <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>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRALEX (ESCITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRALEX (ESCITALOPRAM)</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522884-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-0007470</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRIVA</medicinalproduct>
        <drugauthorizationnumb>21500</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE (TENOFOVIR DISOPROXIL FUMARATE) (300 MG)</medicinalproduct>
        <drugdosagetext>300 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugdosagetext>200 MG, 2 IN 1 D</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE (METHADONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM (BROMAZEPAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522886-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410590BFR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALATE LP (NIFEDIPINE)</medicinalproduct>
        <drugauthorizationnumb>20198</drugauthorizationnumb>
        <drugdosagetext>40 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>40 MG, TOTAL DAILY, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>40 MG, TOTAL DAILY, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPANTHYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OROCAL D (3)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUPHALAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMUREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC BABY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522888-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00404</companynumb>
    <primarysource>
      <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>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522960-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041200143</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>37.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522961-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041200326</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIAL CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIO-THREE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522962-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-JNJFOC-20041201077</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UVEITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522963-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041003450</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522964-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041104712</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522965-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040404255</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.54</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>FIRST DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC DEGENERATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522966-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041003741</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.41</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522967-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040300764</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.04</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</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>PLAQUENIL</medicinalproduct>
        <drugdosagetext>SUNDAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>MONDAY-SATURDAY.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>TAPERING DOSE</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522968-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040907945</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SARCOIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522969-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041004926</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522970-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040909895</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>FOR THE PAST 3 YEARS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522971-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040810067</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACILLUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL 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>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522972-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040706367</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.04</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRE-ECLAMPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>6-MP</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugdosagetext>EXPOSURE TIME IN GESTATIONAL WEEKS-ALL</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522973-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>PT-JNJFOC-20040901424</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLONIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATIOPRINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522974-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041006541</companynumb>
    <primarysource>
      <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>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>2ND INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>1ST INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STABLON</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>MYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMUREL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522975-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041100954</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUCTUS ARTERIOSUS PREMATURE CLOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>6-MP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522977-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>APCDSS2002001469</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>30</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HOARSENESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE SODIUM SUCCINATE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RACOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522978-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20040809301</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL OCCULT BLOOD POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTIVE SPONDYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC SPACE NARROWING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY OCCULT BLOOD POSITIVE</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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SHIOSOL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522979-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040807111</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BILIARY NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522980-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041106197</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>THIRD DOSE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <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</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522981-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041106060</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</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>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRENOCORTICAL HORMONE</medicinalproduct>
        <drugdosagetext>HAS BEEN OB FOR 13 YEARS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENET</medicinalproduct>
        <drugdosagetext>1 DOSE= 1 TABLET</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>1 DOSE= 1 TABLET</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTELUC</medicinalproduct>
        <drugdosagetext>1 DOSE= 1 TABLET</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSSEN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVER</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522982-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20031102332</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>PATIENT STARTED TO TAKE THIS DOSAGE PRIOR TO 07-FEB-2002</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INH</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>STARTED PRIOR TO 07-FEB-2002</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugdosagetext>2 DOSES= 2 TABLETS</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugdosagetext>STARTED PRIOR TO 07-FEB-2002</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522983-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410611BFR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IZILOX (MOXIFLOXACIN HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>400 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMAREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522984-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410645BNE</companynumb>
    <primarysource>
      <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>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>19537</drugauthorizationnumb>
        <drugdosagetext>750 MG , BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522985-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200412564GDS</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522986-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200412945GDS</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HCL</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>400 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040902</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522987-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04P-056-0279959-00</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATATONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugauthorizationnumb>18723</drugauthorizationnumb>
        <drugdosagetext>500 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugauthorizationnumb>18723</drugauthorizationnumb>
        <drugdosagetext>500 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>100 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>100 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXAPINE SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIHEXYPHENIDYL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZUCLOPENTHIXOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEPROMAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEPROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMISULPRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>............</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPRAM TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLORAZEPATE DIPOTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522988-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04P-083-0281699-00</companynumb>
    <primarysource>
      <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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAMMONAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKIN              (SODIUM VALPROATE)</medicinalproduct>
        <drugauthorizationnumb>18081</drugauthorizationnumb>
        <drugdosagetext>500 MG, 4 IN 1 D, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKIN  (DEPACON) (VALPROATE SODIUM)</medicinalproduct>
        <drugdosagetext>400 MG, 5 IN 1 D, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNASYN (AMPICILLIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522989-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04P-028-0282004-00</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE (ULTANE LIQUID FOR INHALATION)</medicinalproduct>
        <drugauthorizationnumb>20478</drugauthorizationnumb>
        <drugdosagetext>8%, ONCE, INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUFENTANIL CITRATE</medicinalproduct>
        <drugdosagetext>0.1 MCG/KG, ONCE</drugdosagetext>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522990-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04P-087-0281439-00</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>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
        <drugauthorizationnumb>18593</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
        <drugauthorizationnumb>18593</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPRAVENTRICULAR TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
        <drugauthorizationnumb>18593</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040326</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
        <drugauthorizationnumb>18593</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPRAVENTRICULAR TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040326</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522991-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04P-056-0281691-00</companynumb>
    <primarysource>
      <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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAVIK</medicinalproduct>
        <drugauthorizationnumb>20528</drugauthorizationnumb>
        <drugdosagetext>2 MG, 1 IN 1 D, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTAZIDE</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORMS, 1 IN 1 D, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>5 MG, 1 IN 1 D, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522992-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004PK02041</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
        <drugauthorizationnumb>21344</drugauthorizationnumb>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522993-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05878</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugdosagetext>10 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS HAEMORRHAGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NO MATCH</medicinalproduct>
        <drugdosagetext>HALF TAKEN EVERY DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KERLONG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU LOTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALOBEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522994-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02407</companynumb>
    <primarysource>
      <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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugdosagetext>20 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEGLOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522995-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210777</companynumb>
    <primarysource>
      <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>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SECTRAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522996-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210882</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522997-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098923</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>110</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORTIS (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIPID METABOLISM DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELIDIUR (FOSINOPRIL SODIUM, HYDROCHLOROTHIAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRENDIPINE (NITRENDIPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN HUMAN INJECTION, ISOPHANE (INSULIN HUMAN INJECTION, ISOPHANE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522998-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101569</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>(10 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4522999-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099433</companynumb>
    <primarysource>
      <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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523000-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102349</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct> ETHOSUXIMDE (ETHOSUXIMIDE)</medicinalproduct>
        <drugauthorizationnumb>12380</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523001-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004088964</companynumb>
    <primarysource>
      <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>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>DECREASED APPETITE</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>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (1 IN 1 D),ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040828</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523002-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004084482</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523003-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.0604</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAYPRO</medicinalproduct>
        <drugdosagetext>600MG  2 X DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041205</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523004-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>209971</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>80 MG, 1/WEEK</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523005-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugbatchnumb>NC027532</drugbatchnumb>
        <drugdosagetext>1GM  Q12H INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISCITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugbatchnumb>NC027532</drugbatchnumb>
        <drugdosagetext>1GM  Q12H INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523006-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>105922</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL (DOCETAXEL) SOLUTION FOR INJECTION</medicinalproduct>
        <drugdosagetext>170 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>600 MG/M2, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN (DOXORUBICIN, DOXORUBICIN HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>60 MG/M2, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMESULIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILGRASTEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523007-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004077318</companynumb>
    <primarysource>
      <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BURNING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>50733</drugauthorizationnumb>
        <drugdosagetext>500 MG (500 MG, 1 IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ERYSIPELAS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523008-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VEIN PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>ONE DAILY</drugdosagetext>
        <drugindication>SPINAL COMPRESSION FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523009-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004079973</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>39.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATOMYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYASTHENIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUADRIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>5 MG (5 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL (CANDESARTAN CILEXETIL)</medicinalproduct>
        <drugdosagetext>4 MG (4 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODEOXYCHOLIC ACID (URSODEOXYCHOLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIASTASE, TAKA (DIASTASE, TAKA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROVITAN (CYANOCOBALAMIN, OCTOTIAMINE, PYRIDOXINE HYDROCHLORIDE, RIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIZOLAM (ETIZOLAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523010-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.6683</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECHOCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>1 QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>1 QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523011-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099943</companynumb>
    <primarysource>
      <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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>84427</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523012-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102993</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>34.4734</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>5 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVOPROST</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523013-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.6376</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN   CAPECITABINE  2600  DAILY X14 DAYS</medicinalproduct>
        <drugdosagetext>130MG/M^2  INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>1.00MG^M2  INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONALACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523014-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098782</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEGALIN-P (SULBACTAM, AMPICILLIN)</medicinalproduct>
        <drugauthorizationnumb>50608</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523015-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099600</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOREA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>1200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC   (DICLOFENAC SODIUM)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523016-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004091819</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENANTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXANTHEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>50784</drugauthorizationnumb>
        <drugdosagetext>500 MG (250 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugdosagetext>1500 MG (500 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEROXACIN (FLEROXACIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYORIN AP 2 (CAFFEINE, SIMETRIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEMASTNE FUMARATE (CLEMASTINE FUMARATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEPRENONE (TEPRENONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOFALCONE (SOFALCONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POVIDONE IODINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523017-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004095904</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY MUSCLE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTAZEM HYDROCHLORIDE (DILTAZEM HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIBOLONE (TIBOLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE (GLUCOSAMINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523018-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S MOTRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523019-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098877</companynumb>
    <primarysource>
      <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>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>20 MG (1 IN 1 D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN (ROSUVASTATIN)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523020-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098901</companynumb>
    <primarysource>
      <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>CHOLECYSTITIS INFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523021-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.977</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>100 MG HS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIVAPROEX ER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERPHENAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523022-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEU-2004-0001148</companynumb>
    <primarysource>
      <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>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALLADONE</medicinalproduct>
        <drugauthorizationnumb>21044</drugauthorizationnumb>
        <drugdosagetext>32 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALLADONE</medicinalproduct>
        <drugdosagetext>2.6 MG, PM, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFUN (PANTOPRAZOLE SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523023-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004212649FR</companynumb>
    <primarysource>
      <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>HYPOGAMMAGLOBULINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL PERCENTAGE DECREASED</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>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>50467</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANTIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE SODIUM SULFOBENZOATE (PRENSIDOLONE SODIUM SULFOBENZOATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOXACIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNSIOLONE SODUM SUCCINATE (METHYLPREDNSIOLONE SODIUM SUCCINAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523025-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040810</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ABBOTT-04P-008-0270076-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIBUTRAMINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040805</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOPTON</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523026-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040902</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-04P-062-0272289-03</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN INTRACRANIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>7.5/5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>7.5/5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTRACRANIAL VENOUS SINUS THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523027-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0282199-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.904</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUCINDOLOL HYDROCHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523028-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0282197-00</companynumb>
    <primarysource></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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HCT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFA SALAX</medicinalproduct>
        <drugdosagetext>3 IN THE MORNING, 3 IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523029-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0282198-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523031-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0281635-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</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>PREDNISOLONE</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>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523032-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1000   Q WEEKLY  INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugdosagetext>100  Q WEEKLY  INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523033-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0282509-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523035-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-2004-035821</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKULL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 300</medicinalproduct>
        <drugauthorizationnumb>20220</drugauthorizationnumb>
        <drugdosagetext>100 ML, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM ABDOMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523036-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugdosagetext>42.48MILLION   Q8HOURS   INTRAVENOU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523037-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-2004-035813</companynumb>
    <primarysource>
      <qualification>1</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>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX TRAUMATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 370</medicinalproduct>
        <drugauthorizationnumb>20220</drugauthorizationnumb>
        <drugdosagetext>120 ML,  INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523038-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12777728</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugbatchnumb>2J94YUCIA</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugbatchnumb>2J94YUCIA</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>STARTED AT 400 MG/DAY, DECREASED TO 300 MG/DAY WHEN ARIPIPRAZOLE WAS INITIATED.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523039-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-2004-035788</companynumb>
    <primarysource>
      <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>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>19596</drugauthorizationnumb>
        <drugdosagetext>PARENTERAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUTENYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523040-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12767091</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>127</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523041-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-12779260</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBOTHROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030930</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>INITIAL DOSE 02-SEP-2004</drugdosagetext>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030930</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>INITIAL DOSE 02-SEP-2003</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030930</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVOBAN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENISTIL</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOSTRIL</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030930</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523042-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12777710</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugbatchnumb>4C86117</drugbatchnumb>
        <drugdosagetext>DURATION OF THERAPY: 6-8 MONTHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523043-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12780557</companynumb>
    <primarysource>
      <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>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELISOR</medicinalproduct>
        <drugdosagetext>DOSAGE FORM = TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523044-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004091938</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>36</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>15 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL (CANDESARTAN CILEXETIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL (ALFACALCIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEPRENONE (TEPRENONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENATETRENONE (MENATETRENONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523045-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12758330</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523046-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BRISTOL-MYERS SQUIBB COMPANY-12779666</companynumb>
    <primarysource>
      <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>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>1/2 OF A 500 MG TABLET TWICE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523047-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</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>LEVETIRACETAM</medicinalproduct>
        <drugdosagetext>1500MG/1000M    AM/PM    ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL-XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KCL TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523048-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.3993</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523049-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.9259</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE   50MG   VA</medicinalproduct>
        <drugdosagetext>1 TABLET   ONCE A DAY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523050-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.2971</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERAZOSIN    2 MG    SYNTEX</medicinalproduct>
        <drugdosagetext>4 MG   QHS  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523051-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48.9885</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADRENOCORTICAL INSUFFICIENCY ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugdosagetext>2   TWICE A DAY   RESPIRATOR</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTEF</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523052-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413531EU</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOTEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PALPITATIONS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORECORMON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523053-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413612JP</companynumb>
    <primarysource>
      <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>TAXOTERE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523054-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004229597JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEPRENONE (TEPRENONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA LEAF (SENNA LEAF)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSENN (ACHILLEA, RUBIA ROOT TINCTURE, SENNA FRUIT, SENNA LEAF, TARAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXATIDINE ACETATE HYDROCHLORIDE (ROXATIDINE ACETATE HYDRCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523055-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004239511DE</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>8 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OLIVOPONTOCEREBELLAR ATROPHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523056-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004224840JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIRSUTISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>20753</drugauthorizationnumb>
        <drugdosagetext>25 MG (25 MG, DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EURODIN (ESTAZOLAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523057-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPAREUNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOESTRIN/MICROGESTIN  UNKNOWN       UNKNOWN</medicinalproduct>
        <drugdosagetext>21    28     ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALESSE</medicinalproduct>
        <drugdosagetext>21    28    ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523058-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100639</companynumb>
    <primarysource>
      <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 SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>5 MG (5MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523059-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004242158IS</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALAZOPYRIN EN TABLETS        (SULFASALAZINE)</medicinalproduct>
        <drugauthorizationnumb>7073</drugauthorizationnumb>
        <drugdosagetext>2 GRAMS/DAY (500 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523060-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>50MG   HS    ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523061-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16392</companynumb>
    <primarysource>
      <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>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>40 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523062-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041200135</companynumb>
    <primarysource>
      <qualification>2</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>CONCERTA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523063-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041200468</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRUXISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523064-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040306766</companynumb>
    <primarysource>
      <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 HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL FAECES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NARCOTIC INTOXICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0327192</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0327192</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0327192</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0327192</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0327192</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0327192</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0327192</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METACLOPROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523065-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098572</companynumb>
    <primarysource>
      <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>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPERAZONE (SULBACTAM, CEFOPERAZONE)</medicinalproduct>
        <drugauthorizationnumb>50551</drugauthorizationnumb>
        <drugdosagetext>3 GRAM (1.5 GRAM, 2 IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL BACTERAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIME (CEFEPIME)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523066-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041106415</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523067-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041106292</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523068-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041201690</companynumb>
    <primarysource>
      <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>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523069-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040804975</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PERSPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OILY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0331764</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0331764</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LSD</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523070-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.8748</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>50MG/KG = 3090 MG IV QD X 4</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523071-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CA16374</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugbatchnumb>S02300</drugbatchnumb>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523072-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004081882</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORTIS (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>5 MG (5 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIAL OCCLUSIVE DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19971215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIOCTIC ACID (THIOCTIC ACID)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523073-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004090193</companynumb>
    <primarysource>
      <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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugauthorizationnumb>19949</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 WK), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523074-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040910217</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.7</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATRECOR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>AM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugdosagetext>AM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>1 PUFF BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>PM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIROLACTONE</medicinalproduct>
        <drugdosagetext>BEDTIME/AM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMADEX</medicinalproduct>
        <drugdosagetext>4 IN AM AND 1 IN PM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>1/2 TAB QPM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>QPM  AND ^BID^</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523075-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE03904</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLANTAR FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIOISOTOPE SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID FACTOR INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CO-DIOVAN</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523076-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB03989</companynumb>
    <primarysource>
      <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>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040729</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523077-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004085265</companynumb>
    <primarysource>
      <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>EXANTHEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>50670</drugauthorizationnumb>
        <drugdosagetext>500 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523078-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210614</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>5 MG/KG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>5-FLUOROURACIL 9FLUOROURACIL)</medicinalproduct>
        <drugdosagetext>3200 MG, 1/WEEK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATIN)</medicinalproduct>
        <drugdosagetext>80 MG, 1/WEEK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBOFLAVIN (RIBOFLAVIN)</medicinalproduct>
        <drugdosagetext>800 MG, 1/WEEK</drugdosagetext>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE (LEVOTHYROXINE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRENDIPIN (NITRENDIPINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523079-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1509</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTION TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE ROOT LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORIMOTOR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELESTAN DEPOT INJECTABLE SUSPENSION ^LIKE CELESTONE SOLUSPAN^</medicinalproduct>
        <drugauthorizationnumb>14602</drugauthorizationnumb>
        <drugdosagetext>1 ML QD INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOSTESIN INJECTABLE</medicinalproduct>
        <drugdosagetext>1 ML 0.5% QD INTRACUSCUL</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523080-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004TH14547</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELMAC</medicinalproduct>
        <drugdosagetext>UNK MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040218</drugenddate>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523081-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101525</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugauthorizationnumb>20150</drugauthorizationnumb>
        <drugdosagetext>TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE 9GLICLAZIDE0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACARBOSE (ACARBOSE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523082-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BR16117</companynumb>
    <primarysource>
      <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>ZELMAC</medicinalproduct>
        <drugdosagetext>6 MG, QD</drugdosagetext>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523083-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>5MG/ 10-20 5MG/ 10-21 5MG/ 10-21 5MG/ 10-23 5MG/ 10-23 5MG/ 10-24</drugdosagetext>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041024</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523084-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1594</companynumb>
    <primarysource>
      <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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>150 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugdosagetext>28 GY TOTAL X-RAY THERAP</drugdosagetext>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINORELBINE TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523085-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRACYCLINE</medicinalproduct>
        <drugdosagetext>500 MG PO Q8H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRACYCLINE</medicinalproduct>
        <drugdosagetext>500 MG PO Q8H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040729</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523086-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>20040058USST</companynumb>
    <primarysource>
      <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>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARNITENE (L-CARNITINA) (LEVOCARNITINE INJECTION)</medicinalproduct>
        <drugauthorizationnumb>20182</drugauthorizationnumb>
        <drugdosagetext>2 G, IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOX (LANSOPRAZOLE)</medicinalproduct>
        <drugdosagetext>30 MG/DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAAKIX(MAGNESIUM  HYDR., ALLUMINIUM HYDR.)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTIROX (THIROXINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBILOX (NEBIVOLOL CHLORID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPREX (EPOETIN ALPHA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL (SELVELAMER)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFIN *SUCRALPHATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIJEX (CALCITHRIOLOLO)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523087-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004IM000924</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIASTOLIC HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFERGEN</medicinalproduct>
        <drugdosagetext>9 UG; TIW; SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVELAMER HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM POLYSTYRENE SULFONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN ALFA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523088-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000063</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX LIQUID (INTERFERON BETA)</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523089-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0007</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPALGIC INJECTABLE SOLUTION (TRAMADOL HCL)</medicinalproduct>
        <drugauthorizationnumb>21165</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AERIUS (DESLORATADINE) TABLETS  'LIKE LCARINEX'</medicinalproduct>
        <drugdosagetext>5 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFERALGAN CODEINE TABLETS</medicinalproduct>
        <drugdosagetext>2 TABS TID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DI-ANTALVIC CAPSULES</medicinalproduct>
        <drugdosagetext>2 CAPS QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYSANXIA TABLETS</medicinalproduct>
        <drugdosagetext>20 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXOMIL (BROMAZEPAM) TABLETS</medicinalproduct>
        <drugdosagetext>12 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523090-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US11515</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASCARA SAGRADA</medicinalproduct>
        <drugdosagetext>UNK, TID</drugdosagetext>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523091-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL SINUS DRAINAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH IMPACTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>1 PER MONTH INFUSION</drugdosagetext>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523092-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12727</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADHESIOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOLVULUS OF BOWEL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIOVASCULAR DRUGS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>1/2 6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>76</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523093-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-10-1524</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A (INTERFERON ALFA-2B RECOMBINANT) INJECTABLE POWEDER</medicinalproduct>
        <drugdosagetext>6 MIU TIW INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE  TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL (BENIDIPINE HCL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEBERA G STRONG INJ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRONGER NEO MINOPHAGEN C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROS TABELTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPOVAS TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM TABLETS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523094-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12795</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTROPHY BREAST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523095-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004077590</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABYRINTHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDURA XL</medicinalproduct>
        <drugauthorizationnumb>19668</drugauthorizationnumb>
        <drugdosagetext>4 MG (4 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL (CANDESARTAN CILEXETIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDERGIN ^SANDOZ^ (DIHYDROERGOCORNINE MESILATE, DIHYDROERGOCRISTINE ME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN (VALSARTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523096-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100174</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN HYDROCHLORIDE (EPIRUBICIN HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>50778</drugauthorizationnumb>
        <drugdosagetext>185 MG (CYCLIC - EVERY 3 WEEKS), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL (DOCETAXEL)</medicinalproduct>
        <drugdosagetext>130 MG (CYCLIC - EVERY 3 WEEKS), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGFILGRASTIM (PEGFILGRASTIM)</medicinalproduct>
        <drugdosagetext>6 MG (CYCLIC - EVERY 3 WEEKS), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523097-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.9467</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>340 MG IVPB QOW</drugdosagetext>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>340 MG IVPB QOW</drugdosagetext>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>340 MG IVPB QOW</drugdosagetext>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>340 MG IVPB QOW</drugdosagetext>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>340 MG IVPB QOW</drugdosagetext>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>340 MG IVPB QOW</drugdosagetext>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAMPTOSAR W/ AVASTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523098-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100535</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>186.4284</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE REDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523099-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419186US</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL ANTIDIABETICS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523100-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419228US</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO STOMACH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENA CAVA THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPERCOAGULATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS, PLAIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523101-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419316US</companynumb>
    <primarysource>
      <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>CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523102-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101091</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>2 MG (2 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMOCRIPTINE MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIHEXYPHENIDYL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523103-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHANGE OF BOWEL HABIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE COATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>10 MG 1/DAILY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523104-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101126</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
        <drugauthorizationnumb>20597</drugauthorizationnumb>
        <drugdosagetext>1 DROP (1 DROP), INTRAOCULAR</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT (CORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523105-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004FI14982</companynumb>
    <primarysource>
      <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>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHANOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHARCOAL, ACTIVATED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugdosagetext>200 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugdosagetext>UNK, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523106-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0019</companynumb>
    <primarysource>
      <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>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugauthorizationnumb>20762</drugauthorizationnumb>
        <drugdosagetext>1PUFF/NARE * NASAL SPRAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040816</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523107-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.2252</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523108-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100046</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523109-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1581</companynumb>
    <primarysource>
      <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>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RINDERON               (BETAMATHASONE SODIUM PHOSPHATE)</medicinalproduct>
        <drugauthorizationnumb>17561</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523110-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100140</companynumb>
    <primarysource>
      <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>ANISOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHROPOIESIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POIKILOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYCHROMASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>21130</drugauthorizationnumb>
        <drugdosagetext>600 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WOUND INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAVULIN            (AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523111-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1572</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523112-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.6162</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXXAR</medicinalproduct>
        <drugdosagetext>89.8 MCI IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523113-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004091025</companynumb>
    <primarysource>
      <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 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG (W0 MG, 1 IN 1 D),</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLAMMATION LOCALISED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID HORMONES          (THYROID HORMONES)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523114-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1603</companynumb>
    <primarysource>
      <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GARASONE           (GENTAMICIN SULFATE/BETAMETHASONE SOD PHOSPOTIC)</medicinalproduct>
        <drugauthorizationnumb>50039</drugauthorizationnumb>
        <drugdosagetext>FEW DROPS AD OTIC</drugdosagetext>
        <drugindication>POSTOPERATIVE ANALGESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523115-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410529</companynumb>
    <primarysource>
      <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>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISIONAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DYSPORT (BOTULINUM TOXIN TYPE A)</medicinalproduct>
        <drugdosagetext>150 UNITS PRN IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MUSCLE CONTRACTIONS INVOLUNTARY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DYSPORT (BOTULINUM TOXIN TYPE A)</medicinalproduct>
        <drugdosagetext>150 UNITS PRN IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>RECTAL PROLAPSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523116-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103034</companynumb>
    <primarysource>
      <qualification>1</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>21341</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523117-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004EU002097</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTOPLASMOSIS DISSEMINATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugindication>HISTOPLASMOSIS DISSEMINATED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugindication>HISTOPLASMOSIS DISSEMINATED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523118-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2001056186IT</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPTOSAR</medicinalproduct>
        <drugauthorizationnumb>20571</drugauthorizationnumb>
        <drugdosagetext>130 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010417</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROBLASTIN          (FLUOROURACIL)</medicinalproduct>
        <drugdosagetext>3280 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>410 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TROPISETRON HYDROCHLORIDE              (TROPISETRON HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523119-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004JP002114</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS SALMONELLA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugindication>BONE MARROW TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523120-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>PLEURISY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>3 PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX XR</medicinalproduct>
        <drugdosagetext>1 PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX XR</medicinalproduct>
        <drugdosagetext>1 PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SOCIAL PHOBIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523121-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004EU002142</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PELVIS FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>0.50 MG/KG,</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523122-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>ONE PER EVENING</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030628</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523123-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0277498-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULTRASOUND FOETAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523124-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040223</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0251145-00</companynumb>
    <primarysource></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 CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULTRASOUND ANTENATAL SCREEN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULTRASOUND FOETAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523125-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004EU001515</companynumb>
    <primarysource>
      <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>BETA HAEMOLYTIC STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTED LYMPHOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FK506 (TACROLIMUS) CAPSULE</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>3.00 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523126-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041200657</companynumb>
    <primarysource>
      <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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOLASETRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAHISTINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOTHIEPIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523127-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-JNJFOC-20030705342</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </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>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523128-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-JNJFOC-20030705338</companynumb>
    <primarysource>
      <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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523130-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004090807</companynumb>
    <primarysource>
      <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>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugbatchnumb>BA0177</drugbatchnumb>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugdosagetext>2 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANASTROZOLE (ANASTROZOLE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523131-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>1 TAB DAILY - ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523132-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100056</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523133-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523134-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100475</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523135-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>30.7992</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DESQUAMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugdosagetext>300 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523136-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12786208</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIXY321</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523137-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>650 MG/M2/QWK/IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>400 MG BID / PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523138-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-12786356</companynumb>
    <primarysource>
      <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>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RECTAL CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523139-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8008187</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>500 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDO K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523140-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100619</companynumb>
    <primarysource>
      <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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523141-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8008186</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>1 G/D</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugdosagetext>1.5 G/D</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANNITOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523142-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8008083</companynumb>
    <primarysource>
      <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>ANTICONVULSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BICYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</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>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>1000 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>400 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>200 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523143-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</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>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>1/2 PILL QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>1/2 PILL QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523144-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8008198</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>250 MG 2/D TRP</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>100 MG 2/D TRP</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULPHATE ANHYDROUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523145-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004095017</companynumb>
    <primarysource>
      <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>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, ONCE), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>500 MG (500 MG, 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP APNOEA SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523146-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004NL15792</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>.5 MG, TID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523147-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.5442</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>400 MG 2 TID</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>400 MG 2 TID</drugdosagetext>
        <drugindication>TUBEROUS SCLEROSIS</drugindication>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523148-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8008197</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>116.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>1.5 G 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011225</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523149-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84.369</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4MG IN 0.9% NS 1X MONTH IN 100ML IV INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523150-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004083742</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>2.5 MG (2.5 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN (VALSARTAN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523151-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004US001312</companynumb>
    <primarysource>
      <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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugauthorizationnumb>50740</drugauthorizationnumb>
        <drugdosagetext>250.00 MG, UID/QD, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugauthorizationnumb>50740</drugauthorizationnumb>
        <drugdosagetext>250.00 MG, UID/QD, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIENAM            (IMIPENEM, CILASTATIN, CILASTATIN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOCIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABELCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IDARUBICIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523152-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8006516</companynumb>
    <primarysource>
      <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>ALCOHOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF SPOUSAL ABUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523153-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004241787JP</companynumb>
    <primarysource>
      <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>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERGOLIDE MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMOCRIPTINE MESYLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523154-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.2356</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>2 TIMES /DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523155-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>045-0981-M0000039</companynumb>
    <primarysource>
      <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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY REOCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN           (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>80 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBYL-ENTEROSOLUBILE              (ACETYLSALICYLIC ACID, MAGNESIUM OXI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523156-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004016393</companynumb>
    <primarysource>
      <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>ALVEOLITIS FIBROSING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D</drugdosagetext>
        <drugindication>AORTIC ANEURYSM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>1 IN 1 D</drugdosagetext>
        <drugindication>AORTIC ANEURYSM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523157-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>UKP04000446</companynumb>
    <primarysource>
      <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>ACTONEL</medicinalproduct>
        <drugauthorizationnumb>20835</drugauthorizationnumb>
        <drugdosagetext>35 MG, 1/WEEK, ORAL</drugdosagetext>
        <drugadministrationroute>004</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523158-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004048188</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>900 MG (300 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523159-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523160-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004081020</companynumb>
    <primarysource>
      <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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DIATHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROBILIN URINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 ), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugdosagetext>200 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>300 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN ASPART (INSULIN ASPART)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA LEAF                       (SENNA LEAF)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523161-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.246</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE PATCH (EQUATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523162-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20041201388</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERENASE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEREUPIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523163-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041200419</companynumb>
    <primarysource>
      <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>REMINYL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
        <drugtreatmentduration>200</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>AS REQUIRED, ACCORDING TO BLOOD SUGAR</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523164-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041200355</companynumb>
    <primarysource>
      <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>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ANOREXIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523165-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041003910</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IATROGENIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBIN BLOOD INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugbatchnumb>04BS62G</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugbatchnumb>04BS62G</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugindication>PARKINSONISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFARLEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523166-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041006580</companynumb>
    <primarysource>
      <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>ANOREXIA NERVOSA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-CARDIAC CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCREASE MT 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCREASE MT 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCREASE MT 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC 220</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523167-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041200828</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERWEIGHT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523168-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>K200401821</companynumb>
    <primarysource></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>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>19901</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO ( ) TABLET</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EZETIMIBE (EZETIMIBE)</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEBUTOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANORIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTEF</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523169-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>K200401819</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HYPOGLYCAEMIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>19901</drugauthorizationnumb>
        <drugdosagetext>1 TABLET, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>1 TABLET, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTRAPHANE HM (INSULIN HUMAN INJECTION, ISOPHANE) 30/70</medicinalproduct>
        <drugdosagetext>32 IU, QD, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTRAPHANE HM REGIMEN #2</medicinalproduct>
        <drugdosagetext>26 IU, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYOTENSIN (NITRENDIPINE) TABLET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523170-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE06650</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523171-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000048</companynumb>
    <primarysource>
      <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>ARRHYTHMIA SUPRAVENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOALVEOLAR LAVAGE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCAPNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEGIONELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>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>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEVALIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEVALIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTINEOPLASTIC AGENTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523172-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-SOLVAY-00204004295</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27002</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED THERAPY (PERINDOPRIL VS PLACEBO)</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 8 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031025</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523173-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_25440_2004</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
        <drugauthorizationnumb>17794</drugauthorizationnumb>
        <drugdosagetext>1 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMNIUM /SCH/</medicinalproduct>
        <drugdosagetext>1 DF Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
        <drugdosagetext>DF TID</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
        <drugdosagetext>62.5 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523174-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_25439_2004</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
        <drugauthorizationnumb>17794</drugauthorizationnumb>
        <drugdosagetext>DF Q DAY TRAN-P</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>DF Q DAY TRAN-P</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIMAX</medicinalproduct>
        <drugdosagetext>DF Q DAY TRAN-P</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523175-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE06651</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523176-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_25455_2004</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASOCARDOL</medicinalproduct>
        <drugbatchnumb>49971</drugbatchnumb>
        <drugauthorizationnumb>18602</drugauthorizationnumb>
        <drugdosagetext>180 MG Q DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523177-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEU-2004-0000967</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523178-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2004-0017893</companynumb>
    <primarysource>
      <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>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523179-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEU-2004-0001145</companynumb>
    <primarysource></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>AREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF BODY TEMPERATURE CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE VESICLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO PAIN STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE INJ</medicinalproduct>
        <drugdosagetext>1 MG, SINGLE, OTHER</drugdosagetext>
        <drugindication>EPIDURAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>SEE TEXT, OTHER</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPIVACAINE</medicinalproduct>
        <drugdosagetext>SEE TEXT, OTHER</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMYLAL SODIUM (THIAMYLAL SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523180-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030418</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US035892</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYASTHENIA GRAVIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523181-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US094089</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.9</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELOFIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD CELLS, PACKED HUMAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-LOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523182-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE246230NOV04</companynumb>
    <primarysource>
      <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>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA LEGIONELLA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523183-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-KDL097402</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523184-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-03702</companynumb>
    <primarysource>
      <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KERATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REITER'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST    (BCG - IT (COMMAUGHT)), AVENTIS PASTEUR LTD.</medicinalproduct>
        <drugdosagetext>81 MG</drugdosagetext>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523185-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02339</companynumb>
    <primarysource>
      <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>ACTIVITIES OF DAILY LIVING IMPAIRED</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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLUBBING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE REDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL PITTING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</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>SKIN BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>10 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERIVASTATIN</medicinalproduct>
        <drugdosagetext>0.4 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugdosagetext>200 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIPOTRIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523186-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-03700</companynumb>
    <primarysource>
      <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>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST (BCG - IT (CONNAUGHT)),</medicinalproduct>
        <drugdosagetext>81 MG / WEEK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523187-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25 MG X1 DAY</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523188-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98.8842</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25 MG /1 X DAY</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523189-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.8331</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25 MG PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523191-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523192-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523194-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>ORAL 10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>ORAL 10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523195-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.0396</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugdosagetext>2-3 Q 2-3 HR #300</drugdosagetext>
        <drugindication>SICKLE CELL ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugdosagetext>Q 8 HR # 90</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523196-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43.3185</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN-SR</medicinalproduct>
        <drugdosagetext>20 MG 2 TAB PO QAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523198-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20 MG / 5 ML 2 TSP Q AM</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20 MG / 5 ML 2 TSP Q AM</drugdosagetext>
        <drugindication>SEVERE MENTAL RETARDATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20 MG / 5 ML 2 TSP Q AM</drugdosagetext>
        <drugindication>STEREOTYPIC MOVEMENT DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523199-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugdosagetext>10 MG BEFORE ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMPAIRED GASTRIC EMPTYING</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugdosagetext>10 MG BEFORE ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugdosagetext>25 MG 6 HRS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523200-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugdosagetext>120 MG  Q 3 WKS X 4</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>350 MG Q 3 WKS X 4</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>1200 MG Q 3 WKS X 4</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523201-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.8122</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
        <drugdosagetext>2 X ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TINEA PEDIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930707</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523202-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.8122</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>1 X</drugdosagetext>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523203-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102.9665</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUBERSOL</medicinalproduct>
        <drugdosagetext>.5  INTRADERMAL</drugdosagetext>
        <drugadministrationroute>023</drugadministrationroute>
        <drugindication>TUBERCULIN TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041204</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523204-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004PK00229</companynumb>
    <primarysource>
      <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>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEAK EXPIRATORY FLOW RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNX DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>14394</drugauthorizationnumb>
        <drugdosagetext>2 SPRAY</drugdosagetext>
        <drugindication>ENDOSCOPY UPPER GASTROINTESTINAL TRACT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>14394</drugauthorizationnumb>
        <drugdosagetext>2 SPRAY</drugdosagetext>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRACAINE POLYGYL STERILE OPHTHALMIC SOLUTION</medicinalproduct>
        <drugindication>ENDOSCOPY UPPER GASTROINTESTINAL TRACT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRACAINE POLYGYL STERILE OPHTHALMIC SOLUTION</medicinalproduct>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523205-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AQUASOL A</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523206-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.2252</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>25 MG 1 BID</drugdosagetext>
        <drugindication>VENTRICULAR EXTRASYSTOLES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523207-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05997</companynumb>
    <primarysource></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>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANAPEINE</medicinalproduct>
        <drugauthorizationnumb>20533</drugauthorizationnumb>
        <drugdosagetext>4 ML/ HR ED</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>EPIDURAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNASYN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523208-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>200 MG/M2 IV OVER 3 HR ON DAY 1, EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LARGE CELL CARCINOMA OF THE RESPIRATORY TRACT STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>6 AUC IV OVER 30 MIN ON DAY 1, EVERY 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZD1839: 250 MG PO QD CYCLE = 21 DAYS</medicinalproduct>
        <drugdosagetext>250 MG PO QD CYCLE = 21 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY CYCLES 3-9</medicinalproduct>
        <drugdosagetext>TOTAL DOSE 6600 CGY FRACTIONS QD ON DAYS 1-5 QW, FOR TOTAL OF 33 FRACTIONS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523209-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SUSI-2004-00805</companynumb>
    <primarysource>
      <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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugauthorizationnumb>20049</drugauthorizationnumb>
        <drugdosagetext>750 MG, 3X/DAY TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523210-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>L00381</drugbatchnumb>
        <drugdosagetext>25 MG SQ TWICE WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523211-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02411</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugbatchnumb>1020179A2</drugbatchnumb>
        <drugauthorizationnumb>19627</drugauthorizationnumb>
        <drugdosagetext>100 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugdosagetext>1 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEBRIDAT ^PARKE DAVIS^</medicinalproduct>
        <drugdosagetext>100 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523212-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE06648</companynumb>
    <primarysource></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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>50 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HALLUCINATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELDOX</medicinalproduct>
        <drugdosagetext>20 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HALLUCINATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENITEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIOBE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITOXIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAREVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523213-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-04-1053</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINIDIPINE TABLETS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523214-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1597</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>140 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugdosagetext>X-RAY THERAPY</drugdosagetext>
        <drugindication>GLIOBLASTOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523215-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP06072</companynumb>
    <primarysource></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>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523216-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05785</companynumb>
    <primarysource></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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUROTEP JANSSEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPEMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523217-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AC00853</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>400 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>100 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523218-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523219-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AC00902</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD PROLACTIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>200 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTHIADEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNI-TRAUXENE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523220-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.2554</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAL FUNCTIONS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>1 EVERY DAY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>1 EVERY DAY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>1 EVERY DAY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523221-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.2762</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MENINGITIS TUBERCULOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXAMAB EVERY 2 MONTHS</medicinalproduct>
        <drugdosagetext>EVERY 2 MONTHS</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523222-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-09-1592</companynumb>
    <primarysource>
      <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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext> 600 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>6 MU QD-TIW* INTRAMUSCUL</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>6 MU QD-TIW* INTRAMUSCUL</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>6 MU QD-TIW* INTRAMUSCUL</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRONG NEO-MINOPHAGEN C INJECTABLE SOLUTION 40 ML</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLDEM INJECTABLE SOLUTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION TABLETS 0.25 MG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERSANTIN INJECTABLE SOLUTION 200 MG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523223-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE587009APR03</companynumb>
    <primarysource>
      <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>ANTI FACTOR VIII ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULATION FACTOR VII LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULATION FACTOR VIII LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REFACTO</medicinalproduct>
        <drugbatchnumb>200290932</drugbatchnumb>
        <drugdosagetext>1000 IU EVERY OTHER DAY (11 IU/KG)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030407</drugenddate>
        <drugtreatmentduration>147</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REFACTO</medicinalproduct>
        <drugbatchnumb>200191171</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REFACTO</medicinalproduct>
        <drugbatchnumb>2002P0137</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REFACTO</medicinalproduct>
        <drugbatchnumb>2002P0931</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REFACTO</medicinalproduct>
        <drugbatchnumb>2002P0933</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REFACTO</medicinalproduct>
        <drugbatchnumb>2002P1230</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REFACTO</medicinalproduct>
        <drugbatchnumb>2002P1617</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DF118 (DIHYDROCODEINE BITARTRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC (DICLOFENAC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523224-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.1324</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>15 MG 1 1/2 QHS</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>15 MG 1 1/2 QHS</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030428</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523225-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>PO 25 M X 2</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523226-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98.8842</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>50 MG/1X DAY</drugdosagetext>
        <drugindication>INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523227-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-02082</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MILIARY PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST (BCG - IT (CONNAUGHT))</medicinalproduct>
        <drugdosagetext>81.0 MG</drugdosagetext>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OFLOCET</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OFLOCET PLACEBO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IZILOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENUTRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIMETANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOROXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXACYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACICOLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZALDIER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INONGAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUPHALAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523228-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02404</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugbatchnumb>1020179A2</drugbatchnumb>
        <drugauthorizationnumb>19627</drugauthorizationnumb>
        <drugdosagetext>100 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugdosagetext>1 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEBRIDAT</medicinalproduct>
        <drugdosagetext>100 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523229-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>200 MG 2X DAY</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugdosagetext>500 MG/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523230-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN 150 MG</medicinalproduct>
        <drugbatchnumb>0490609-03602</drugbatchnumb>
        <drugdosagetext>1 CAP 3 TIMES A DAY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523231-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02432</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EQUANIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KARDEGIC /FRA/</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523232-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-00369</companynumb>
    <primarysource>
      <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>BOVINE TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MILIARY PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST (BCG - IT (CONNAUGHT)), AVENTIS PASTEUR LTD., LOT NOT NEP, I</medicinalproduct>
        <drugindication>BLADDER CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523233-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05757</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAPAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIBADREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523234-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05710</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CSF CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>180 MG DAILY</drugdosagetext>
        <drugindication>NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugindication>NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523235-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>1-2 TABS PO Q 4-6 H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC PROTRUSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523236-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugdosagetext>10 MG 1 1/2 QID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523237-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CORNEAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugbatchnumb>358265A</drugbatchnumb>
        <drugdosagetext>DROPS TO NUMB EYES</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523238-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05072</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-SMALL CELL LUNG CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXOLON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLOXYL WITH SENNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISACODYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AQUEOUS CREAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLOCAINE VISCOUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONJELA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523239-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.2554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZICAM</medicinalproduct>
        <drugdosagetext>NORMAL</drugdosagetext>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523240-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05893</companynumb>
    <primarysource></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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHANGIOSIS CARCINOMATOSA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040903</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN NA LOCK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARNAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGIZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARUYAMA VACCINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523241-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>340 MG IV Q 21 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523242-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.7913</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODEINE/APAP (MALLINDKRODT)</medicinalproduct>
        <drugdosagetext>30/300 2 Q 6 H PRN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODEINE/APAP (MALLINDKRODT)</medicinalproduct>
        <drugdosagetext>30/300 2 Q 6 H PRN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENIUM TRACE METAL ADDITIVE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523243-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1 GM IV Q 25 H</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1 GM IV Q 25 H</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041208</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523245-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE06654</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>100 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>200 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523246-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523247-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>600079</companynumb>
    <primarysource>
      <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>CSF CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS ASEPTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD S/D</medicinalproduct>
        <drugdosagetext>ONCE; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010518</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523248-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>601440</companynumb>
    <primarysource>
      <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 PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TISSUCOL/TISSEL KIT STIM4 (2-COMP FIBRIN SEALANT, FREEZE-DRIED, VAPOR </medicinalproduct>
        <drugdosagetext>2 ML; TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HERNIA REPAIR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040727</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523249-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CART-10385</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>195</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHONDROMALACIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHONDROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARTICEL</medicinalproduct>
        <drugdosagetext>1 NA ONCE IS</drugdosagetext>
        <drugindication>ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010827</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523250-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATIONS, MIXED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugdosagetext>450 MG IV Q 12 HRS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugdosagetext>300 MG IV Q 12 HR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM + SULFAMETHOXAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523251-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>601647</companynumb>
    <primarysource>
      <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>INHIBITING ANTIBODIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECOMBINATE</medicinalproduct>
        <drugdosagetext>PRN; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030306</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523252-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugdosagetext>390 MG IV Q 12 H</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugdosagetext>260 MG IV Q 12 H</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILGRASTIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523253-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041010</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>601143</companynumb>
    <primarysource>
      <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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE III IMMUNE COMPLEX MEDIATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVATE (ANTIHEMOPHILIC FACTOR (RECOMBINANT), PLASMA/ALBUMIN FREE METHO</medicinalproduct>
        <drugbatchnumb>LE01C018AK</drugbatchnumb>
        <drugdosagetext>1000 UNITS</drugdosagetext>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVATE (ANTIHEMOPHILIC FACTOR (RECOMBINANT), PLASMA/ALBUMIN FREE METHO</medicinalproduct>
        <drugbatchnumb>01C015AD</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523254-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL101225</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523255-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.1834</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 + 20 MG 1 A DAY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523256-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>601648</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FACTOR VIII INHIBITION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct> ADVATE           (ANTIHEMOPHILIC FACTOR (RECOMBINANT), PLASMA/ALBUMIN</medicinalproduct>
        <drugbatchnumb>LE01C017AD</drugbatchnumb>
        <drugdosagetext>500 IU; PRN</drugdosagetext>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVATE (ANTIHEMOPHILIC FACTOR (RECOMBINANT), PLASMA/ALBUMIN FREE METHO</medicinalproduct>
        <drugbatchnumb>LE01C015AG</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523257-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410171BSV</companynumb>
    <primarysource>
      <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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMIMUNE N 10%</medicinalproduct>
        <drugbatchnumb>26N1702 OR 26N0TC2</drugbatchnumb>
        <drugdosagetext>100 G , TOTAL DAILY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>WEGENER'S GRANULOMATOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523258-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.6683</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugdosagetext>AMIODARONE ORAL 200 MG DAILY 047</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORPACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523260-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR DEMENTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB 100 MG</medicinalproduct>
        <drugdosagetext>CAPSULE 2 X DAY</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523261-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.1324</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugindication>BIPOLAR II DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523264-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02190</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVLOCARDYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANAKAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523265-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>601547</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS C POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECOMBINATE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD AND RELATED PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523266-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPIL FIXED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEVASE</medicinalproduct>
        <drugdosagetext>1 UNIT / HR FOR 4 HR,THEN 0.5 UNITS/HR X 10 HR</drugdosagetext>
        <drugindication>THROMBOLYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030403</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523267-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>601546</companynumb>
    <primarysource>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS C POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECOMBINATE</medicinalproduct>
        <drugdosagetext>50 IU/KG; QOD; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD AND RELATED PRODUCTS</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4523268-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410390BBE</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMIMUNE N 10%</medicinalproduct>
        <drugdosagetext>30 G, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>IMMUNODEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>4523269-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.0187</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>1098256 A 2</drugbatchnumb>
        <drugdosagetext>75 MG ONCE DAILY - ORAL (047)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POSTOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>1098256 A 2</drugbatchnumb>
        <drugdosagetext>75 MG ONCE DAILY - ORAL (047)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>4523270-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THYM-10360</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>TH100-06</drugbatchnumb>
        <drugdosagetext>150  MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERI-COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523271-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24302</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523272-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410548BYL</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>11.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE VESICLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMIMUNE N 5%</medicinalproduct>
        <drugbatchnumb>26N2LW1</drugbatchnumb>
        <drugdosagetext>10.0 G, TOTAL DAILY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>KAWASAKI'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMIMUNE N 5%</medicinalproduct>
        <drugbatchnumb>26N2LW1</drugbatchnumb>
        <drugdosagetext>12.5 G, TOTAL DAILY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>KAWASAKI'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOTIAM HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VEEN-3G</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523273-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02557</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEFITINIB</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEFITINIB</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GTN SPRAY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORMORPH</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523274-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410874BCA</companynumb>
    <primarysource>
      <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>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMUNEX</medicinalproduct>
        <drugbatchnumb>26N4HH1</drugbatchnumb>
        <drugdosagetext>80 G, QD, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMUNEX</medicinalproduct>
        <drugbatchnumb>26N4HH1</drugbatchnumb>
        <drugdosagetext>20 G, QD, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BURKITT'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523275-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.5964</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE 200 MG/DAY</medicinalproduct>
        <drugdosagetext>200 MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </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>METOPROLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523276-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041106352</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEGIONELLA INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523277-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-JNJFOC-20041200079</companynumb>
    <primarysource>
      <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>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523278-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-JNJFOC-20041200210</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPPORTUNISTIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</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>STEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523279-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20041200409</companynumb>
    <primarysource>
      <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>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>1 YEAR.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523280-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-JNJFOC-20041200428</companynumb>
    <primarysource>
      <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>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523281-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041200444</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.43</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523282-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041200607</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523283-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20040806925</companynumb>
    <primarysource>
      <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>DEATH</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>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODYDRAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODYDRAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523284-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20040301259</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADENOCARCINOMA PANCREAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR CALCIFICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELDENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523285-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20041103780</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEDERTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523286-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041004740</companynumb>
    <primarysource>
      <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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROTID GLAND ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</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>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>DOSE HAS BEEN INCREASED TO UNKNOWN AMOUNT.</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEMETACIN</medicinalproduct>
        <drugdosagetext>90 TO 180 MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523287-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040909072</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>41.73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>04C091P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>04C091P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523288-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20040201527</companynumb>
    <primarysource>
      <qualification>1</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>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDA PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>FISTULA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugdosagetext>DOSE/DAY REPORTED AS ^12 T^</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTERAL NUTRITION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZANIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELENTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELENTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523289-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040805688</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103.87</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>TOTAL NUMBER OF INFUSIONS= 11</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523290-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20041106393</companynumb>
    <primarysource>
      <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>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugdosagetext>NINE DOSES SINCE JAN-02.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523291-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523292-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20041201015</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ALKALOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL DECANOATE</medicinalproduct>
        <drugdosagetext>PRES. DOSE WAS HALOPERIDOL 5MG; GIVEN 2 AMP./DAY HALOPERIDOL DEC.FOR 3 DAYS TO 4 AMP/DAY FOR 4 DAYS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DISSOCIATIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030223</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523293-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-UK101107</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SHUNT OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-PHOSPHAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523294-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THYM-10350</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523295-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMIPENEM / CILASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523296-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003PK01435</companynumb>
    <primarysource>
      <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>ANOSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugdosagetext>113 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugdosagetext>113 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugdosagetext>113 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugdosagetext>113 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>5-FLOUROURACIL</medicinalproduct>
        <drugdosagetext>3000 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>5-FLOUROURACIL</medicinalproduct>
        <drugdosagetext>3000 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>5-FLOUROURACIL</medicinalproduct>
        <drugdosagetext>3000 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>5-FLOUROURACIL</medicinalproduct>
        <drugdosagetext>3000 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERGENTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVOBAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIANI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMPUR COMPOSITUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSTAGUTT FORTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALGIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523297-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410862BCA</companynumb>
    <primarysource>
      <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>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMUNEX</medicinalproduct>
        <drugbatchnumb>26N3V71</drugbatchnumb>
        <drugdosagetext>20 G, QD, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523298-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>5 MG ONCE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523299-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05983</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOCAIN</medicinalproduct>
        <drugauthorizationnumb>89408</drugauthorizationnumb>
        <drugdosagetext>5 ML  IT</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOCAIN</medicinalproduct>
        <drugdosagetext>20 ML IT</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523300-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THYM-10118</companynumb>
    <primarysource>
      <qualification>3</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>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM REPOLARISATION ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM SICKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugdosagetext>50 MG QD IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>400 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugdosagetext>500 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugdosagetext>500 MG QID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523301-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugdosagetext>540MG IV Q 12 HRS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FUNGAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugdosagetext>360MG IV Q 12 HRS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPTOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOPENEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASPOFUNGIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523302-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-UK100957</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SHUNT OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECORTIN-H</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELOC ZOK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM ACETATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-PHOSPHAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXONIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523303-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-UK100955</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHUNT OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILATREND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM ACETATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GODAMED</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523304-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05615</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugauthorizationnumb>18240</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIMOBENDAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523305-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugdosagetext>490 MG IV 12 HRS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICOAZOLE</medicinalproduct>
        <drugdosagetext>327 MG IV 12 HRS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPTOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523306-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-05002</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SICK SINUS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugauthorizationnumb>73352</drugauthorizationnumb>
        <drugdosagetext>25 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugdosagetext>100 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523307-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041103959</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>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AURICULAR SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DESQUAMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM LACTATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugadministrationroute>003</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBAMIPIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELBINAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILNACIPRAN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILNACIPRAN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523308-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041200339</companynumb>
    <primarysource>
      <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>BETA 2 MICROGLOBULIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BETA-N-ACETYL-D-GLUCOSAMINIDASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523309-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041200412</companynumb>
    <primarysource>
      <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>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>BRONCHIECTASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523310-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041105881</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>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RELAPSING FEVER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUGUAN M</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUGUAN M</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPAPHENONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523311-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1000235</companynumb>
    <primarysource>
      <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>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACITRETIN (ACITRETIN)</medicinalproduct>
        <drugauthorizationnumb>19821</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523312-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000109</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</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>
      <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>4523313-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-13094RO</companynumb>
    <primarysource>
      <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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>84612</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523314-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000110</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THYROID 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>20040728</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523315-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041200939</companynumb>
    <primarysource>
      <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 CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATATONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETIT MAL EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNITRAZEPAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPIRIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHINESE MEDICINES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523316-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040902335</companynumb>
    <primarysource>
      <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>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523317-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000117</companynumb>
    <primarysource></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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P30077</drugbatchnumb>
        <drugdosagetext>30 QG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523318-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000112</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.4514</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UQ; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523319-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000111</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</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>19971001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UQ; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523320-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000118</companynumb>
    <primarysource></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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</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>20020802</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>20041025</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523321-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20041201127</companynumb>
    <primarysource>
      <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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugdosagetext>PATIENT TOOK 10 TABLETS AT ONE TIME</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>10 TABLETS AT ONE TIME</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugdosagetext>20 TABLETS AT ONE TIME</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523322-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000180</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC 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>20011109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</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>20031101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523323-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000120</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P30077</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523324-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-13091RO</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY STEROID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>84612</drugauthorizationnumb>
        <drugdosagetext>10 MG Q6H (TAPER AT END) (4 MG), PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPEREMESIS GRAVIDARUM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523325-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM STIMULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOSYNCRATIC DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENASAL (OXYMETAZOLINE HCL) 0.05% GOLDLINE MIAMI FL</medicinalproduct>
        <drugbatchnumb>AW 203</drugbatchnumb>
        <drugdosagetext>2 SQUIRTS MIL NARES X 1</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>EPISTAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523326-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MC200400828</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANGIOMAX</medicinalproduct>
        <drugauthorizationnumb>20873</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANGIOMAX</medicinalproduct>
        <drugauthorizationnumb>20873</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE (DOPAMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUBAN ^DUPONT PHARMA^ (NALBUPHINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISIPAQUE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523327-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>T04-USA-07232-01</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</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>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523328-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.0187</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523329-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1819</companynumb>
    <primarysource>
      <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>NITRO-DUR</medicinalproduct>
        <drugauthorizationnumb>20145</drugauthorizationnumb>
        <drugdosagetext>TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523330-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>230228M04USA</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT 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>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOPYRIDINE (FAMPRIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE (PRAMIPEXOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGEN (ESTROGEN NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAPIN (CLONAPIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523331-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE    200MG   EON PHARMACEUTICALS</medicinalproduct>
        <drugdosagetext>200MG  QD  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523332-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40MG   QD   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA CONCENTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523333-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>50MG   TAPERED   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSYLLIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523334-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16154</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523335-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>ONCE DAILY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523336-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SUSI-2004-00800</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPIL FIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO PAIN STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO VERBAL STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>71479</drugauthorizationnumb>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523337-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200MG DAILY</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200MG DAILY</drugdosagetext>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugdosagetext>25MG  TWICE D</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugdosagetext>25MG  TWICE D</drugdosagetext>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523338-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004071256</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>124.7392</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>40 MG (20 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523339-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099647</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>84349</drugauthorizationnumb>
        <drugdosagetext>300 MG (100 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523340-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugdosagetext>400MG  QD    ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYELONEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040326</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523341-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100388</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOULDER ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>900 MG (300 MG, 3 IN 1 D),</drugdosagetext>
        <drugindication>NEUROPATHIC PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523342-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004US16402</companynumb>
    <primarysource>
      <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>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN LOBECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLEX PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>1200 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COMPLEX PARTIAL SEIZURES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>600 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>1200 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugdosagetext>2000 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COMPLEX PARTIAL SEIZURES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523343-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>30MG   ONE TIME  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523344-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102565</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.1637</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL STRICTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>(2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
        <drugdosagetext>(1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST (MONTELUKAST)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN (TELMISARTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523345-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15899</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STARSIS</medicinalproduct>
        <drugdosagetext>270 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUITRAN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOZYM</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523346-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugdosagetext>400MG   X1   INTRAVENOU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugdosagetext>400MG   X1   INTRAVENOU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugdosagetext>200MG  X1   INTRAVENOU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040405</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523347-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101326</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523348-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2004US00471</companynumb>
    <primarysource>
      <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>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS NEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITTING OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCROTAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYMPANIC MEMBRANE HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN (NGX) (AMOXICILLIN TRIHYDRATE) UNKNOWN</medicinalproduct>
        <drugauthorizationnumb>64076</drugauthorizationnumb>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523349-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US11013</companynumb>
    <primarysource></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>CARDIOPULMONARY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523350-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugdosagetext>400MG  QD  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040306</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL EXTENDED RELEASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523351-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB03989</companynumb>
    <primarysource>
      <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>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040729</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523352-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR I DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJACULATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOGORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>300 MG  QD  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALCOHOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>300 MG  QD  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>100 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>100 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523353-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2004US00473</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENOCORTICAL INSUFFICIENCY ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE (NGX) (DEXAMETHASONE) UNKNOWN</medicinalproduct>
        <drugauthorizationnumb>80399</drugauthorizationnumb>
        <drugdosagetext>8 MG/DAILY,  ;  16 MG/DAILY,</drugdosagetext>
        <drugindication>LIVER DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN (WARFARIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523354-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODAL ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>30MG  BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523355-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020924</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>001-0981-M0008063</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS (ERGOCALCIFEROL,ASCORBIC ACID, FOLIC ACID, THIAMINE HYDR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON (IRON)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523356-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100191</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, AS NEEDED),</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523357-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2004A01497</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.2043</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIPOMA EXCISION</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>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523358-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>300MG  TID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523359-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.3795</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE  10MG   WATSON LAB</medicinalproduct>
        <drugdosagetext>1 TAB  ONE TIME ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523360-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ATO-03-0807</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.3597</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRISENOX</medicinalproduct>
        <drugauthorizationnumb>21248</drugauthorizationnumb>
        <drugdosagetext>11.5 MG (0.25 MG/KG, 5X/WK, 2WKS ON 2WKS OFF), IVI</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523361-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ATO-03-0746</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.3597</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HILAR LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRISENOX</medicinalproduct>
        <drugauthorizationnumb>21248</drugauthorizationnumb>
        <drugdosagetext>11.5 MG (0.25 MG/KG, 5X/WK, 2 WKS ON 2 WKS OFF), IVI</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523362-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-MERCK-0411CHE00036</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHIAL OBSTRUCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523363-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00893</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULINDAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523364-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00452</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523365-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0411FRA00038</companynumb>
    <primarysource>
      <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>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASODILATATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL AND NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523366-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKA SELTZER GOLD</medicinalproduct>
        <drugdosagetext>3 TO 4 PACKETS (6 - 8 TABLETS) A DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523367-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0410USA03828</companynumb>
    <primarysource>
      <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>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOLYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523368-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0304USA00834</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>111</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY RESTENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010401</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010801</drugenddate>
        <drugtreatmentduration>146</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010401</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010801</drugenddate>
        <drugtreatmentduration>146</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031210</drugenddate>
        <drugtreatmentduration>2170</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031210</drugenddate>
        <drugtreatmentduration>2170</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEART RATE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRONASE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031210</drugenddate>
        <drugtreatmentduration>1051</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523369-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-032344</companynumb>
    <primarysource>
      <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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCCUPATIONAL PROBLEM ENVIRONMENTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>UA0293A</drugbatchnumb>
        <drugdosagetext>9.6 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523370-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-03-016755</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.7</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU,  EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL PM (DIPHENHYDRAMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS (CORTICOSTEROID NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523371-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.2971</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>250MG ONCE DAILY ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>75MG/M2</drugdosagetext>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>100MG/M2  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523372-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-030028</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.9</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS (PANTHENOL, RETINOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/HYDROCODONE BITARTRATE (HYDROCODONE BITARTRATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523373-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugdosagetext>TOOK DAILY</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL XR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523374-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-10893</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</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>20030527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIATX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523375-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00694</companynumb>
    <primarysource>
      <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>ACCELERATED HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST WALL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOARSENESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTRIGLYCERIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT CRAMPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE</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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AXOCET (ACETAMINOPHEN (+) BUTALBITAL)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523376-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415858BCC</companynumb>
    <primarysource></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>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>440-660 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523377-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415734BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NISENTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVATAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523378-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0410FRA00013</companynumb>
    <primarysource>
      <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>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM DUODENAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN LYSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040905</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523379-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020812</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0208USA02294</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523380-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030929</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0310USA00134</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>136</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL WALL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAUSTIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEMICAL BURN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIASTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOARSENESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERURICAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT CREPITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABYRINTHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523381-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>206677</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.2147</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523382-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>205206</companynumb>
    <primarysource>
      <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>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523383-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000540</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523384-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00636</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>111</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST WALL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF CRIME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523385-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>174774</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>107.9561</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.....</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523386-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2001-01-0827</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.1219</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGE INDETERMINATE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugbatchnumb>9BBS546</drugbatchnumb>
        <drugauthorizationnumb>17559</drugauthorizationnumb>
        <drugdosagetext>ORAL AER INH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugbatchnumb>9BBS532</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugbatchnumb>9BBS565</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugbatchnumb>8BBS593</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugbatchnumb>8BBS606</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugbatchnumb>9BBS613</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugbatchnumb>9BBS633</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AQUABID DM (GUAIFENESIN/DEXOMETHORPHAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523387-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA01133</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANORECTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY RESTENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACET JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOARSENESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RAYNAUD'S PHENOMENON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNORING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORTHALIDONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYGROTON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001105</drugenddate>
        <drugtreatmentduration>350</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010621</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001105</drugenddate>
        <drugtreatmentduration>350</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010621</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523388-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00749</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOMALACIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIC BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURODERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523389-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00820</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAMILY STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLANTAR FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPOROMANDIBULAR JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000810</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE AND TRIAMTERENE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523390-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030929</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0310USA00080</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COW'S MILK INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS EROSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER PYLORI IDENTIFICATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRODIURIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYCOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYCOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROQUICK</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523391-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CIP04002553</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugauthorizationnumb>20835</drugauthorizationnumb>
        <drugdosagetext>35 MG ONCE WEEKLY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523392-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8000950</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.54</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOGORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL ASSAULT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>250 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>125 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>125 MG1/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523393-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030929</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0310USA00135</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL FUNCTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEG AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOE AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOE DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEHISCENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523394-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000267</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</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>20030501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523395-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000244</companynumb>
    <primarysource>
      <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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL 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>19990101</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>20040819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLOZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523396-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugbatchnumb>401580</drugbatchnumb>
        <drugdosagetext>IM 1.55 ML</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugbatchnumb>304620</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523397-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004073860</companynumb>
    <primarysource>
      <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>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>160 MG (2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR II DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>160 MG (2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR II DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM (MELOXICAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARVEA HCT (HYDROCHLOROTHIAZIDE, IRBESARTAN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523398-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.4932</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugdosagetext>RITALIN 25 MG (OA,12P, 20MG)</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523399-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-031028</companynumb>
    <primarysource>
      <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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID PREPARATIONS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLORZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523400-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE385111NOV04</companynumb>
    <primarysource>
      <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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECONOMIC PROBLEM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>75 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523401-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004US-00410</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY ASPHYXIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM (LORAZEPAM) TABLET, 0.5MG</medicinalproduct>
        <drugbatchnumb>1394180</drugbatchnumb>
        <drugauthorizationnumb>76045</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523402-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004091385</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523403-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00483</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC PROTRUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040626</drugenddate>
        <drugtreatmentduration>556</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>HORMONES (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523404-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0307USA00400</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA OF CHRONIC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIODYSPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICOBRACHIAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULAR PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP COLORECTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DENAVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523405-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100559</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IATROGENIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT PALATE NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>(50 MG)</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523406-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.0802</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>80 MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523409-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>TAXOL 80MG/M2 IV Q WK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>CARBO AUC 6 IV Q 4 WKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>CARBO AUC 6 IV Q 4 WKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>CARBO AUC 6 IV Q 4 WKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>CARBO AUC 6 IV Q 4 WKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>2 MG/KG IV QWK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>2 MG/KG IV QWK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523411-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100560</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523413-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON - BETA 1B</medicinalproduct>
        <drugbatchnumb>UA1832A</drugbatchnumb>
        <drugdosagetext>.25 ML DOSE OF 250 MG EOD, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON - BETA 1B</medicinalproduct>
        <drugbatchnumb>UA2985A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523415-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2004-0017284</companynumb>
    <primarysource>
      <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>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM LOW VOLTAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRINOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>19516</drugauthorizationnumb>
        <drugdosagetext>30 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugdosagetext>370 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>140 MG, SINGLE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPYRONE TAB</medicinalproduct>
        <drugdosagetext>400 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1000 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523416-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40.8237</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>1 TSP BID</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523418-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>203165</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43.0917</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANT SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO MUSCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED CELL DISTRIBUTION WIDTH INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION ENTEROCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION FUNGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</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>19990201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</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>20040524</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>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMHRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>4-AMINOPYRIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523420-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000250</companynumb>
    <primarysource></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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</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>20010614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P30043</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523421-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0281898-00</companynumb>
    <primarysource>
      <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>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugauthorizationnumb>18890</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523423-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>205551</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523424-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>127.0072</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25 MG DAILY</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523426-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>201879</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</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>20010406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</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>20040528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523427-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0409USA01316</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN STEM INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011031</drugenddate>
        <drugtreatmentduration>287</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523429-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0407USA01742</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000202</drugenddate>
        <drugtreatmentduration>89</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVOSTIN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523430-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200955</companynumb>
    <primarysource>
      <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>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</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>20001101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523431-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523434-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0410CAN00030</companynumb>
    <primarysource>
      <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>GASTRIC OUTLET OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523436-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>PO ONE Q 8 HRS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523437-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA00363</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523438-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041205</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-028453</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.5</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>UNK, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523439-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA02933</companynumb>
    <primarysource>
      <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>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>768</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>768</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523440-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16391</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BACTERIAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILEUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523442-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0405GBR00191</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALIMUMAB</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROGENS, CONJUGATED</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND DIHYDROCODEINE BITARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523443-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-035800</companynumb>
    <primarysource>
      <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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSIL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523444-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00706</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN, BIPHASIC ISOPHANE [INJECTION]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523445-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0412AUS00039</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523447-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04247</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523448-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-MERCK-0411BEL00038</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020726</drugenddate>
        <drugtreatmentduration>772</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523449-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-033428</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA OF LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL FUNCTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>TB09975A</drugbatchnumb>
        <drugdosagetext>8 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICROGESTIN FE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL ^ACHE^ (AMMONIUM CHLORIDE, MENTHOL, DIPHENHYDRAMINE HYDROCHLO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523450-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0412CAN00049</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523452-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0412AUS00033</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523453-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0412CAN00045</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523454-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-MERCK-0412FIN00004</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AUTOIMMUNE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523455-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00478</companynumb>
    <primarysource>
      <qualification>4</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 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000517</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523456-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03070</companynumb>
    <primarysource>
      <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>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523457-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA04117</companynumb>
    <primarysource>
      <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>THROMBOTIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523459-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03706</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523460-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>7467</companynumb>
    <primarysource>
      <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>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOCAINE 3% (MEPIVACAINE HCL 3%)</medicinalproduct>
        <drugauthorizationnumb>20971</drugauthorizationnumb>
        <drugdosagetext>1 CARPULE</drugdosagetext>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEPTOCAINE (ARTICAINE HCL 4% WITH EPRINEPHRINE 1:100,000)</medicinalproduct>
        <drugbatchnumb>4N95337</drugbatchnumb>
        <drugdosagetext>1 CARPULE</drugdosagetext>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523461-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA04299</companynumb>
    <primarysource>
      <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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
        <drugtreatmentduration>151</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523465-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00740</companynumb>
    <primarysource>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPONDYLOARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523466-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA00810</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DERMADEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAROXOLYN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD POTASSIUM DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFZIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUSSIONEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUSTYN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASALCROM</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRENTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIBID DM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE STRAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030325</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030410</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040406</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANDIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4523468-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.8539</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>25 MG THEN 50 MG 1X A DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>4523469-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03842</companynumb>
    <primarysource>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>4523470-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA01401</companynumb>
    <primarysource>
      <qualification>5</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>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
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        <drugstartdate>20020705</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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    <safetyreportid>4523472-0</safetyreportid>
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    <transmissiondate>20050328</transmissiondate>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00166</companynumb>
    <primarysource>
      <qualification>4</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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    <safetyreportid>4523473-2</safetyreportid>
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    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040618</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200146</companynumb>
    <primarysource>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <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>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QD; IM; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QD; IM; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040530</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523474-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BR16373</companynumb>
    <primarysource>
      <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARLODEL</medicinalproduct>
        <drugbatchnumb>Z0001</drugbatchnumb>
        <drugdosagetext>2.5 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPRESSED LACTATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523475-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0411CAN00143</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011206</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523476-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-MERCK-0412NOR00011</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523478-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00246</companynumb>
    <primarysource>
      <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>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523479-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000087</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P30043</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523480-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00451</companynumb>
    <primarysource>
      <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 DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523481-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00511</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010918</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523482-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00472</companynumb>
    <primarysource>
      <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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523484-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00570</companynumb>
    <primarysource>
      <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>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523485-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00441</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART VALVE INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523486-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00239</companynumb>
    <primarysource>
      <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>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523488-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00562</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523489-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0412GBR00036</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040326</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE AND CHOLECALCIFEROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE DEVELOPMENT ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040328</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPROMELLOSE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>DRY EYE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE DEVELOPMENT ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040127</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND CODEINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040326</drugenddate>
        <drugtreatmentduration>88</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040328</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>WHEEZING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040328</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040322</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523490-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00470</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523492-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00605</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523493-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00776</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523494-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.5338</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>1 TABLET EVERY DAY</drugdosagetext>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>1 TABLET EVERY DAY</drugdosagetext>
        <drugindication>INTERVERTEBRAL DISC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523495-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00781</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523496-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00642</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART VALVE INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523497-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00469</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523498-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00638</companynumb>
    <primarysource>
      <qualification>4</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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523500-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00725</companynumb>
    <primarysource></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>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523501-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00656</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010812</drugenddate>
        <drugtreatmentduration>698</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROPASTE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM FOLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523503-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugdosagetext>ONE QD, 100 MG</drugdosagetext>
        <drugindication>BACTERIAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugdosagetext>ONE QD, 100 MG</drugdosagetext>
        <drugindication>FALL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>.5 MG (1/2 Q AM , ONE HS)</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523506-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.1532</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>IV DOSE FREQ :?</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523508-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01038</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523509-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00637</companynumb>
    <primarysource>
      <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>CARDIAC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL DISABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523510-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030415</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-336268</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALLERGY TO CHEMICALS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY POSITIVE</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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN INTRACRANIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</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</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEARNING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNORING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THORACIC VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugdosagetext>DOSAGE WAS 40MG EVERY DAY FROM 01JUN1999 TO AN UNKNOWN DATE IN JUNE 1999.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugdosagetext>ON AN UNKNOWN DATE IN JUNE 1999 THE DOSE WAS LOWERED TO 20MG EVERY DAY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN-D</medicinalproduct>
        <drugdosagetext>START DATE NOT PROVIDED AND DOSAGE REGIMEN IS REPORTED TO BE TAKEN EVERY DAY (QD).</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523511-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW22634</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.8644</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugauthorizationnumb>19962</drugauthorizationnumb>
        <drugdosagetext>50 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugauthorizationnumb>19962</drugauthorizationnumb>
        <drugdosagetext>50 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040329</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523513-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRALIPID 20%</medicinalproduct>
        <drugbatchnumb>1022034</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRALIPID 20%</medicinalproduct>
        <drugbatchnumb>1019281</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRALIPID 10%</medicinalproduct>
        <drugbatchnumb>1022356</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523515-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER MALFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
        <drugdosagetext>500 PO Q12H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523516-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-0464</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTOIDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>120 MCG QW SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>400 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523518-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL THROMBOSIS LIMB</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugindication>ANORECTAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523520-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CERZ-10667</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>131.5431</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>20367</drugauthorizationnumb>
        <drugdosagetext>7200 UNITS Q2WS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030206</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523522-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-10835</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>114.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</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>20040312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523523-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-304420</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.7</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010418</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010503</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010518</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010531</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010608</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010622</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010723</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010807</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugdosagetext>30 MG GIVEN QAM AND 20 MG GIVEN QPM.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugdosagetext>40 MG GIVEN QAM AND 20 MG GIVEN QPM.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020105</drugenddate>
        <drugtreatmentduration>73</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>STARTED ON 29 MAR 2001 AT 20 MG/DAY FOR ONE WEEK, ON 07 APR DECREASED TO 10 MG/DAY, ON 26 APR TAPER+</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010907</drugenddate>
        <drugtreatmentduration>163</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESIPRAMINE HCL</medicinalproduct>
        <drugdosagetext>INITIALLY 10 MG BID, INCREASED TO 10 MG TID, THEN 25 MG QAM OR AS DESIRED AND FINALLY 25MG QAM AND +</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523524-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.8539</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523525-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040910</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0409USA00879</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>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523527-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-MERCK-0412NLD00003</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040613</drugenddate>
        <drugtreatmentduration>637</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBASPIRIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010903</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523528-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0002469</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>2.268</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IATROGENIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVEDO RETICULARIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING ENTEROCOLITIS NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCEPHALUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY SYNCYTIAL VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING NEONATAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugbatchnumb>305416</drugbatchnumb>
        <drugdosagetext>33 MG, 1 IN 30 D, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523529-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20021210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-327516</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000815</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523530-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19990823</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-214251</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523531-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>12.5 MG IVP PRN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>12.5 MG IVP PRN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523532-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040804</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-376777</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POUCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS ANI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PAPILLOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNORING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523535-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000015</companynumb>
    <primarysource>
      <qualification>3</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>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEVALIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEVALIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEVALIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEVALIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523537-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031016</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-349411</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>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEHISCENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031016</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugdosagetext>FOR FOUR DOSES.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031014</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030922</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031003</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031003</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EINSALPHA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031016</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DREISAVIT N</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031013</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELOC-ZOK MITE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031015</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHO MORONAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROBAY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031020</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN SODIUM/SULBACTAM SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALGIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030925</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORECORMON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031023</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031103</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVASTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523538-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041002736</companynumb>
    <primarysource>
      <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>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523539-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041002339</companynumb>
    <primarysource>
      <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 BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugdosagetext>25-100 UG/HR</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523540-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040904209</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED IMMUNE RESPONSIVENESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0413084</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0413084</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523542-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000076</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DESQUAMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEVALIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEVALIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEVALIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEVALIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523543-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-388104</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIHYDROPYRIMIDINE DEHYDROGENASE DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523544-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-383536</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040710</drugenddate>
        <drugtreatmentduration>339</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>STRENGH PROVIDED AS: 800.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040710</drugenddate>
        <drugtreatmentduration>339</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523545-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-383737</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523546-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED ACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>1 PER DAY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>21140908</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523548-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-381675</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugbatchnumb>LD090308</drugbatchnumb>
        <drugdosagetext>STRENGTH: 1GRAM/50ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523549-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>21154</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102.0593</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE REDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
        <drugdosagetext>500 MG QPM PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG QAM PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BANAIR (UNCONFIRMED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523550-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-386160</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523551-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE ROLLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL RETARDATION SEVERITY UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>400 MG T.I.D</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>5 MG T.I.D.</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523552-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-382230</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST MICROCALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAVITATIONAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SARCOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugdosagetext>GIVEN AT BED TIME</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
        <drugtreatmentduration>330</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED THYMOSIN ALFA 1</medicinalproduct>
        <drugdosagetext>TAKEN IN THE MORNING</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
        <drugtreatmentduration>333</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031030</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523553-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ROCHE-387983</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041127</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523555-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ROCHE-387623</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>FORMULATION REPORTED AS: VIAL</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
        <drugtreatmentduration>259</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
        <drugtreatmentduration>259</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523556-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-385652</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASEPTIC NECROSIS BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugdosagetext>ON DAYS 0,1,2,4,6.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>500 MG DAILY TAPERED TO 10 MG DAILY BY DAY 52.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523557-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-383588</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>122.7</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>410</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>410</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>410</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>2497</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>410</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>UNITS NOT REPORTED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>410</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>410</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>410</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>410</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523558-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-388424</companynumb>
    <primarysource>
      <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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523559-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-387823</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC ISCHAEMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
        <drugtreatmentduration>160</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugdosagetext>3 X AM, 2 X PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
        <drugtreatmentduration>160</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523561-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ROCHE-388043</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugdosagetext>FORM: INJECTION</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE REPORTED AS 100.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523562-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ROCHE-387541</companynumb>
    <primarysource>
      <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>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>DOSAGE ADJUSTED TO REACH PREDEFINED TARGET LEVELS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041127</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>DOSAGE TAPERED ACCORDING TO LOCAL PROTOCOL.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOTAXIM</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLINE</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOBRAMYCIN</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMFOTERICINE B</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATINE</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUMSULFAT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOORHEXIDINEDIGLUCONAAT</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARINE</medicinalproduct>
        <drugindication>DEEP VENOUS THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUMCHLORID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUMGLUCONAT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOL</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523563-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>21385</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
        <drugdosagetext>500 MG QHS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>30 MG QHS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIATUS HERNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523564-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-388332</companynumb>
    <primarysource>
      <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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DALACIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523565-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-388337</companynumb>
    <primarysource>
      <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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXEN LP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040615</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BROMO-KIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LACTATION DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523566-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.7403</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugbatchnumb>3837K</drugbatchnumb>
        <drugdosagetext>250MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugbatchnumb>3605J</drugbatchnumb>
        <drugdosagetext>1MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBITUSSIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523568-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-388391</companynumb>
    <primarysource>
      <qualification>1</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>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>CYCLICAL THERAPY:  TWO WEEKS TREATMENT FOLLOWED BY ONE WEEK REST.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523569-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-388292</companynumb>
    <primarysource>
      <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>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE FOETAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICARDIPINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040615</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523570-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00073</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523571-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>21051</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.8331</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
        <drugdosagetext>1500 MG QHS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523572-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00795</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EX-SMOKER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523575-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>460 MG TID</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523576-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-10-0069</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>APALLIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugbatchnumb>3RPF7</drugbatchnumb>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>115 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRAIN NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523577-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugdosagetext>150 MG/PO/1 TABLET/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLENDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVISTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523579-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>15.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE REDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL</medicinalproduct>
        <drugdosagetext>30MG  TID   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523581-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OMPQ-PR-0412S-1403</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugauthorizationnumb>18956</drugauthorizationnumb>
        <drugdosagetext>170 ML SINGLE DOSE I.A.</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523582-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004US14626</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040406</drugenddate>
        <drugtreatmentduration>370</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>12.5 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RILUTEK</medicinalproduct>
        <drugindication>AMYOTROPHIC LATERAL SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>10 MG, QHS</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugindication>AMYOTROPHIC LATERAL SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
        <drugdosagetext>100 MG, TID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TCH346 VS PLACEBO</medicinalproduct>
        <drugdosagetext>7.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMYOTROPHIC LATERAL SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040918</drugenddate>
        <drugtreatmentduration>80</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TCH346 VS PLACEBO</medicinalproduct>
        <drugdosagetext>NO MEDICATION</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TCH346 VS PLACEBO</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041128</drugenddate>
        <drugtreatmentduration>95040</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TCH346 VS PLACEBO</medicinalproduct>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523583-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12780094</companynumb>
    <primarysource>
      <qualification>1</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523585-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12633509</companynumb>
    <primarysource>
      <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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040420</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523586-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12781225</companynumb>
    <primarysource>
      <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>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523587-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-BRISTOL-MYERS SQUIBB COMPANY-12784369</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523588-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OMPQ-PR-0412S-1405</companynumb>
    <primarysource>
      <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>ARM AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTREMITY NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FINGER AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIAL PULSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugauthorizationnumb>18956</drugauthorizationnumb>
        <drugdosagetext>70 ML SINGLE DOSE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MENTAL STATUS CHANGES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugdosagetext>12 MG SINGLE DOSE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523590-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12781902</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MODECATE INJ</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEPRONIZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFATER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523591-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-BRISTOL-MYERS SQUIBB COMPANY-12784096</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523592-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004HK16425</companynumb>
    <primarysource>
      <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>BLAST CRISIS IN MYELOGENOUS LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSULFAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMATINIB MESILATE</medicinalproduct>
        <drugindication>BLAST CRISIS IN MYELOGENOUS LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523594-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>3 MG 1 DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523595-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TAP2004Q01551</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>35.8342</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT</medicinalproduct>
        <drugauthorizationnumb>20263</drugauthorizationnumb>
        <drugdosagetext>7.5 MG 1 IN 1 M INTRAMUSCULAR; 11.25 MG, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRECOCIOUS PUBERTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT</medicinalproduct>
        <drugauthorizationnumb>20263</drugauthorizationnumb>
        <drugdosagetext>7.5 MG 1 IN 1 M INTRAMUSCULAR; 11.25 MG, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRECOCIOUS PUBERTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523597-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523599-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523601-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523603-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.7507</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext> IV ONCE WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext> IV ONCE WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext> IV ONCE WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>IV ONCE WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>IV ONCE WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>IV ONCE WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIFOSTINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523604-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004HK16427</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT NON-RESECTABLE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRRADIATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523606-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.05</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
        <drugdosagetext>250 MG Q MONTH IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>250 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523607-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004HK16429</companynumb>
    <primarysource>
      <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>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSULFAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRRADIATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523608-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004HK16445</companynumb>
    <primarysource>
      <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>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRRADIATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523609-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117.4816</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>50 MG/M2 IV / 1 HR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>50 MG/M2 IV / 1 HR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>50 MG/M2 IV / 1 HR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>2500 MG DAILY</drugdosagetext>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523610-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031004</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2003NO12562</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LISTERIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugdosagetext>NO MEDICATION</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031004</drugenddate>
        <drugtreatmentduration>108</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030618</drugenddate>
        <drugtreatmentduration>262</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523611-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
        <drugdosagetext>1 TABLET / BY MOUTH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041205</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523612-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004TR16442</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>MYCOSIS FUNGOIDES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS FOR SYSTEMIC USE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugtreatmentduration>152</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523614-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.0604</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOALVEOLAR LAVAGE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOGEN RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BCNU 489 MG DAY( -7)</medicinalproduct>
        <drugdosagetext>489 MG IV -7</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>326 MG IV -6,-5,-4,-3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>326 MG IV -6,-5,-4,-3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>326 MG IV -6,-5,-4,-3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>326 MG IV -6,-5,-4,-3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARA-C 326MG Q 12 (DAYS -6,-5,-4,-3)</medicinalproduct>
        <drugdosagetext>326MG Q 12 DAYS -6,-5,-4,-3</drugdosagetext>
        <drugindication>NON-HODGKIN'S LYMPHOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARA-C 326MG Q 12 (DAYS -6,-5,-4,-3)</medicinalproduct>
        <drugdosagetext>326MG Q 12 DAYS -6,-5,-4,-3</drugdosagetext>
        <drugindication>NON-HODGKIN'S LYMPHOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARA-C 326MG Q 12 (DAYS -6,-5,-4,-3)</medicinalproduct>
        <drugdosagetext>326MG Q 12 DAYS -6,-5,-4,-3</drugdosagetext>
        <drugindication>NON-HODGKIN'S LYMPHOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARA-C 326MG Q 12 (DAYS -6,-5,-4,-3)</medicinalproduct>
        <drugdosagetext>326MG Q 12 DAYS -6,-5,-4,-3</drugdosagetext>
        <drugindication>NON-HODGKIN'S LYMPHOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN 228 MG (DAYS -2)</medicinalproduct>
        <drugdosagetext>228 MG -2</drugdosagetext>
        <drugindication>NON-HODGKIN'S LYMPHOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523620-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-12493169</companynumb>
    <primarysource>
      <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>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTRIGLYCERIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugdosagetext>DOSE INCREASED TO 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugdosagetext>^BABY DOSE^</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTOVASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523622-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12789616</companynumb>
    <primarysource>
      <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>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KAPOSI'S SARCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020423</drugenddate>
        <drugtreatmentduration>427</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STOCRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010221</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523625-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BL000210</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.2762</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VESTIBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEOMYCIN AND POLYMXIN B SULFATES AND HYDROCORTISONE</medicinalproduct>
        <drugbatchnumb>575011</drugbatchnumb>
        <drugauthorizationnumb>64053</drugauthorizationnumb>
        <drugdosagetext>5 DROP ONCE A DAY RIGHT EAR</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEOMYCIN AND POLYMXIN B SULFATES AND HYDROCORTISONE</medicinalproduct>
        <drugbatchnumb>575011</drugbatchnumb>
        <drugauthorizationnumb>64053</drugauthorizationnumb>
        <drugdosagetext>5 DROP ONCE A DAY RIGHT EAR</drugdosagetext>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>^WATER PILL^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523627-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.8644</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>VARIES /QD/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERIPHERAL VASCULAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523628-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040311</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410874JP</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIINFLAMMATORY THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL MUCOSAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523629-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200412219JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORCAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLAKAY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINORIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUER</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BREDININ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRONG NEO-MINOPHAGEN C</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEPATIC FUNCTION ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040629</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523630-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.586</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugbatchnumb>337J2483</drugbatchnumb>
        <drugdosagetext>ONE TAB PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROZYCHLOROQUINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXALT-MLT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE/ACETAMINOPHEN (DARVOCET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523631-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MC200400851</companynumb>
    <primarysource>
      <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>EXSANGUINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANGIOMAX</medicinalproduct>
        <drugauthorizationnumb>20873</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523632-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>12.5 MG/2 X DAY</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523636-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.8957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTRICHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523639-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>115.6672</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25 MG 1 X DAY</drugdosagetext>
        <drugindication>JOINT INJURY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523640-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>209320</companynumb>
    <primarysource>
      <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>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>300 MG, 1/MONTH</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR (SALMETEROL XINAFOATE, FLUTICASONE PROPIONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCOLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523643-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG 1 DAILY</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523647-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.1532</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugdosagetext>1 TAB PO /DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523648-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>K200401780</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>118.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>19901</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR ^DIECKMANN^ (SIMVASTATN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE (GLUCOSAMINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523649-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLONIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>1 TAB DAILY BY MOUTH</drugdosagetext>
        <drugindication>CAROTID ARTERY OCCLUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>1 TAB DAILY BY MOUTH</drugdosagetext>
        <drugindication>CORONARY ARTERY OCCLUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTRACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TROPROL XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRO PATCH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523650-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>K200401833</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugauthorizationnumb>21301</drugauthorizationnumb>
        <drugdosagetext>25 MCG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOVIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL (METRONIDAZOLE BENZOATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523651-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24718</companynumb>
    <primarysource>
      <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>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANDESARTAN</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugdosagetext>16 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANDESARTAN</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugdosagetext>16 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANDESARTAN</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugdosagetext>16 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPRIN ^BAYER^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISORDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523652-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugbatchnumb>2500LFX</drugbatchnumb>
        <drugdosagetext>400 MG IV Q 12 H [2 DOSES]</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523654-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041200634</companynumb>
    <primarysource>
      <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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523656-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>2 PER DAY</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523658-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugdosagetext>25 MG /1X DAY</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523662-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>0.4536</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugindication>BACK DISORDER</drugindication>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523663-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SUSI-2004-00774</companynumb>
    <primarysource>
      <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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL (AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMIN</medicinalproduct>
        <drugauthorizationnumb>11522</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL (AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMIN</medicinalproduct>
        <drugdosagetext>160 MG</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523668-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS ORBITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG ORALLY DAILY</drugdosagetext>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523669-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031009</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0414227G</companynumb>
    <primarysource>
      <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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENGERIX-B</medicinalproduct>
        <drugbatchnumb>ENG5446A4</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030729</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HAVRIX</medicinalproduct>
        <drugbatchnumb>DVHA775C4</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030529</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031006</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523670-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040220</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0500552A</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</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 WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF MUTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950801</drugstartdate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523671-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24644</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>400 MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COCAINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523672-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040514</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0511882A</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR PSEUDOANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KCL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRENTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROPATCH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523673-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040803</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0532857A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE COLD AND SINUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523674-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0534698A</companynumb>
    <primarysource>
      <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523675-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0535639A</companynumb>
    <primarysource>
      <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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOAMING AT MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STARING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>2G FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugdosagetext>200MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugdosagetext>250MG IN THE MORNING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugdosagetext>500MG AT NIGHT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523676-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536019A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523677-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBPFL-E-20040005</companynumb>
    <primarysource>
      <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>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugdosagetext>25MGK CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040610</drugenddate>
        <drugtreatmentduration>117</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>2MGK CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040610</drugenddate>
        <drugtreatmentduration>117</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523678-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-A0536390A</companynumb>
    <primarysource>
      <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>BRONCHIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugdosagetext>40MG CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LARYNGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040528</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>400MG CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LARYNGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040528</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>120MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LARYNGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAROXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASASANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKENAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDALIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523679-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536525A</companynumb>
    <primarysource>
      <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>CHOKING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTIN</medicinalproduct>
        <drugdosagetext>250MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523680-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536675A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>121.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>250MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNISOLIDE</medicinalproduct>
        <drugdosagetext>2SPR TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>400MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>100MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523681-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536690A</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
        <drugtreatmentduration>110</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
        <drugtreatmentduration>110</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523682-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19920318</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-B0157003A</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
        <drugdosagetext>2G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LOBAR PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19891121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19891126</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19891119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19891127</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19891121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19891207</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19891121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19891127</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMETIDINE</medicinalproduct>
        <drugdosagetext>800MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19891108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19891127</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
        <drugdosagetext>4G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19891113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19891127</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19891026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19891121</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRIED FERROUS SULPHATE</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19891026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19891127</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523683-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030220</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0293314A</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULATION FACTOR V LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME SHORTENED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030218</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFFU K</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030227</drugenddate>
        <drugtreatmentduration>55</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030224</drugenddate>
        <drugtreatmentduration>82</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030224</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORLAX</medicinalproduct>
        <drugdosagetext>3SAC PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030224</drugenddate>
        <drugtreatmentduration>53</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523684-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030828</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-GLAXOSMITHKLINE-B0308089A</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INGUINAL HERNIA, OBSTRUCTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZINACEF</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030525</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030522</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HCL</medicinalproduct>
        <drugdosagetext>1.8G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030603</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>.8G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030603</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANESTHESIA FOR OPERATIVE PROCEDURE</medicinalproduct>
        <drugindication>SURGERY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523685-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0323413A</companynumb>
    <primarysource>
      <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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugdosagetext>150MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040121</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523686-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040810</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0342692A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXOPROFEN</medicinalproduct>
        <drugdosagetext>60MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040823</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040823</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROTROPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDARABINE</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523687-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040825</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0343895A</companynumb>
    <primarysource>
      <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>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040802</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFADIN</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATYPICAL MYCOBACTERIAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATYPICAL MYCOBACTERIAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULGUT</medicinalproduct>
        <drugdosagetext>800MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCTIVE COUGH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYDOXAL</medicinalproduct>
        <drugdosagetext>90MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugdosagetext>1500MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODACIN</medicinalproduct>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523688-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0347548A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUTAMEN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEFIX</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEO-MINOPHAGEN C</medicinalproduct>
        <drugdosagetext>80ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYSIO 35</medicinalproduct>
        <drugdosagetext>500ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>10IU PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCAGON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRESH FROZEN PLASMA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523689-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041008</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0347667A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>225MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523690-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0349715A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CLONIC CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DERMATOMYOSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA NICOTINATE</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugdosagetext>.25MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GATIFLO</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPEN</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM LACTATE</medicinalproduct>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041017</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523691-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0349718A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugdosagetext>.25MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALIMATE</medicinalproduct>
        <drugdosagetext>15G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERKALAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523692-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0350060A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>850MG THREE TIMES PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523693-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0350095A</companynumb>
    <primarysource>
      <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>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MORPHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DESQUAMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugdosagetext>50MCG PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITH</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>100MCG PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARDEPHYLLIN</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAIBOKU-TO</medicinalproduct>
        <drugdosagetext>2UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTAL</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040807</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523694-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0350834A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTERIXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC INDUCED ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugdosagetext>800MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPENON</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TACHYCARDIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOLAN</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TACHYCARDIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
        <drugdosagetext>81MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUSO-JO</medicinalproduct>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACIDOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEFANIL</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSBLOCK</medicinalproduct>
        <drugdosagetext>4500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARASENA-A</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523695-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0351245A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSLALIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugdosagetext>200MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYASPIRIN</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VASCULAR SHUNT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>50MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAIO-KANZO-TO</medicinalproduct>
        <drugdosagetext>2.5G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523696-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0357145A</companynumb>
    <primarysource>
      <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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MODACIN</medicinalproduct>
        <drugdosagetext>1G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>20MG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOFLUID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMEDIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALAZOPYRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEILAX</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>ALTAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAIREI-TO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENAMIN</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523697-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0357156A</companynumb>
    <primarysource>
      <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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010516</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPIRIDE</medicinalproduct>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010604</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010604</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugdosagetext>1500MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010604</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523698-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004JP002060</companynumb>
    <primarysource>
      <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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523699-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0358387A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040123</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEGLOR</medicinalproduct>
        <drugdosagetext>2UNIT TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORTHOSTATIC HYPOTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040123</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523700-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0358618A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030224</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugdosagetext>300MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030224</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugdosagetext>40MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030224</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOROXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030224</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>KAPOSI'S SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030224</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523701-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-GLAXOSMITHKLINE-B0358672A</companynumb>
    <primarysource>
      <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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLIXONASE</medicinalproduct>
        <drugdosagetext>300MCG PER DAY</drugdosagetext>
        <drugindication>ALLERGIC SINUSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523702-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0358728A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPHREN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FARMORUBICINE</medicinalproduct>
        <drugdosagetext>117MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLUDECADRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>588MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugdosagetext>588MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523703-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-GLAXOSMITHKLINE-B0358861A</companynumb>
    <primarysource>
      <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>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYCAMTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040906</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523704-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0358929A</companynumb>
    <primarysource>
      <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>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040719</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523705-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359028A</companynumb>
    <primarysource>
      <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>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>1.2G SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>120MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
        <drugdosagetext>20MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75MG 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>ZOPICLONE</medicinalproduct>
        <drugdosagetext>7.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>1G FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugdosagetext>50MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugdosagetext>1UNIT TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>10ML TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GTN</medicinalproduct>
        <drugdosagetext>2MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugdosagetext>4MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSCOPAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENSURE PLUS</medicinalproduct>
        <drugdosagetext>1UNIT TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523706-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359029A</companynumb>
    <primarysource>
      <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>ALCOHOL INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMVIR</medicinalproduct>
        <drugdosagetext>750MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES VIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523707-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359033A</companynumb>
    <primarysource>
      <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>DEPRESSIVE SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEARFULNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugdosagetext>50MCG TWICE PER DAY</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugdosagetext>400MCG TWICE PER DAY</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>200MCG AS REQUIRED</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523709-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359039A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030107</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523710-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-GLAXOSMITHKLINE-B0359377A</companynumb>
    <primarysource>
      <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>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCORD</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523711-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-GLAXOSMITHKLINE-B0359954A</companynumb>
    <primarysource>
      <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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRIDOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATOVAQUONE + PROGUANIL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523712-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AC00869</companynumb>
    <primarysource>
      <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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST INTERFERENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>400 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABNORMAL BEHAVIOUR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
        <drugdosagetext>250 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABNORMAL BEHAVIOUR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUVOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPRAM TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523713-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-GLAXOSMITHKLINE-B0359955A</companynumb>
    <primarysource>
      <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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYMYALGIA RHEUMATICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523714-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-GLAXOSMITHKLINE-B0359959A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>16</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>425MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523715-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>386483</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SILENT MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILATREND</medicinalproduct>
        <drugdosagetext>3.125MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523716-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-GLAXOSMITHKLINE-B0360084A</companynumb>
    <primarysource>
      <qualification>1</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>ZIAGEN</medicinalproduct>
        <drugdosagetext>300MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523717-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0045421A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>116</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYCAMTIN</medicinalproduct>
        <drugdosagetext>1.25MGM2 PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN EPITHELIAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020802</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>175MGM2 PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN EPITHELIAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREOSULFAN</medicinalproduct>
        <drugdosagetext>5GM2 PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN EPITHELIAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN EPITHELIAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523718-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0045431A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUKERAN</medicinalproduct>
        <drugdosagetext>2MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523719-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040406</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BR04700</companynumb>
    <primarysource></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>ASEPTIC NECROSIS BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL SOFT TISSUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOTAC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARMUSTINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523721-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24570</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYUREA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523725-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040406</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BR04703</companynumb>
    <primarysource></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>ASEPTIC NECROSIS BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>90 MG MONTHLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LETROZOLE</medicinalproduct>
        <drugdosagetext>2.5 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>80 MG/M2 WEEKLY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>75 MG/M2 MONTHLY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MITOMYCIN</medicinalproduct>
        <drugdosagetext>10 MG/M2 MONTHLY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1000 MG/M2 WEEKLY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugdosagetext>20 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CURETTAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG MONTHLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031119</drugenddate>
        <drugtreatmentduration>546</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS,OTHER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523726-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>300 MG AM 600 MG PM</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523728-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004RU10770</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDULLARY THYROID CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SICK SINUS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROIDECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE VS PLACEBO</medicinalproduct>
        <drugbatchnumb>67792</drugbatchnumb>
        <drugdosagetext>DOUBLE-BLIND</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>2 OT, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D3</medicinalproduct>
        <drugdosagetext>2 OT, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-THYROXIN</medicinalproduct>
        <drugdosagetext>75 OT, Q12H</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANZYNORM FORTE</medicinalproduct>
        <drugdosagetext>3 OT, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020609</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KREON</medicinalproduct>
        <drugdosagetext>3 OT, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030916</drugenddate>
        <drugtreatmentduration>100</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030916</drugenddate>
        <drugtreatmentduration>100</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEZYM FORTE</medicinalproduct>
        <drugdosagetext>3 OT, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040724</drugenddate>
        <drugtreatmentduration>180</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO-SPA</medicinalproduct>
        <drugdosagetext>3 OT, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040205</drugenddate>
        <drugtreatmentduration>14400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>300 UG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINEX</medicinalproduct>
        <drugdosagetext>6 OT, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040714</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCREATIN</medicinalproduct>
        <drugdosagetext>3 OT, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EGLONYL</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040718</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523729-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004RU15699</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS NONINFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VESICAL TENESMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE VS PLACEBO</medicinalproduct>
        <drugdosagetext>DOUBLE-BLIND</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030922</drugenddate>
        <drugtreatmentduration>347</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523731-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004US17217</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>111</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>125 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID VS PLACEBO</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>30 ML, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523734-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>LIFE TIME O NEED</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523737-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>105.6881</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL OCCULT BLOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5 MG DAILY</drugdosagetext>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523742-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR02812</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>600 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>800 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPASFON</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523743-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04438</companynumb>
    <primarysource>
      <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>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>600MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523744-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.5036</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOOLS WATERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE/SENNA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523747-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>107.0489</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE</medicinalproduct>
        <drugdosagetext> 8 MG DAILY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG DAILY</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523751-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.4827</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>4 MG DAILY</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523753-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.5442</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>250 MG TID</drugdosagetext>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523756-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004ES14238</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUTISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEGATIVISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUDIOMIL</medicinalproduct>
        <drugdosagetext>150 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugdosagetext>300 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBOXETINE</medicinalproduct>
        <drugdosagetext>8 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>S-ADENOSYL-L-METHIONINE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523757-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.3273</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROFECOXIB 50 MG</medicinalproduct>
        <drugdosagetext>25 MG DAILY</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG DAILY</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523763-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40MG  Q12H  INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40MG  Q12H  INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TPN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523765-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugdosagetext>40 MG  QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523769-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04339</companynumb>
    <primarysource>
      <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>EXOMPHALOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523785-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>136.0791</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>50.MG  1X DAILY  OROPHARINGEAL</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>50.MG  1X DAILY  OROPHARINGEAL</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021224</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523788-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </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>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>5MG/KG  D 1+15  INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>35MG/M2  D1,8+15 INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523792-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>400MG  TWICE DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523795-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugdosagetext>500 MG  EVERY 8 HOURS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABSCESS DRAINAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE</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>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523798-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>163.2949</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL   25MG</medicinalproduct>
        <drugdosagetext>1 A DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041211</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523801-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>CONTRAST MEDIA REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TECHNESCAN HDP</medicinalproduct>
        <drugbatchnumb>170809</drugbatchnumb>
        <drugdosagetext>22 MCI    ONE TIME INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE SCAN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523803-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.0083</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>900 MG   ONCE A WEEK  INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>700 MG  ONCE A WEEK  INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCREASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE/APAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523808-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>60 MG 1XDAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523810-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugbatchnumb>W417414745</drugbatchnumb>
        <drugdosagetext>1 BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTNIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523815-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
        <drugbatchnumb>0411731</drugbatchnumb>
        <drugdosagetext>1 DAILY</drugdosagetext>
        <drugindication>BLADDER DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523818-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>GM4981</drugbatchnumb>
        <drugdosagetext>20 MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523819-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>GP0108</drugbatchnumb>
        <drugdosagetext>20MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523820-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>1 PER DAY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>1 PER DAY</drugdosagetext>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>1 PER DAY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>1 PER DAY</drugdosagetext>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021114</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523822-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugdosagetext>50MG  DAILY</drugdosagetext>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523824-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTAL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA FUNGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugindication>DRUG INEFFECTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugindication>DRUG INEFFECTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARA C</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523826-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004PH16939</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CO-DIOVAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523828-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugdosagetext>10MG  TWICE A DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523830-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugdosagetext>TWICE DAILY</drugdosagetext>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011217</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523837-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03182</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFLON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELISOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COTAREG</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>79</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523839-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.3899</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HESPAN 1-LITER  ALBUMIN ?</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HESPAN 1-LITER  ALBUMIN ?</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SHOCK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523845-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</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>RISPERDAL CONSTA</medicinalproduct>
        <drugdosagetext>50 MG IM Q 2 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugdosagetext>50 MG IM Q 2 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugdosagetext>50 MG IM Q 2 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE ER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523848-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>AFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHORIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>400 MG TID</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>400 MG TID</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523852-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>40 MG HS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523855-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.4514</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE REPLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QRS AXIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGICAL PROCEDURE REPEATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AORTIC HEART VALVE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523856-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12697</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>160 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523858-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004NZ14512</companynumb>
    <primarysource>
      <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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL - SLOW RELEASE</medicinalproduct>
        <drugdosagetext>150 MG, BIW</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCYCLIDINE HYDROCHLORIDE 2MG TAB</medicinalproduct>
        <drugdosagetext>5 MG, TID, PRN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>23040</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523859-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004IT14958</companynumb>
    <primarysource>
      <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>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST REMOVAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISIONAL DRAINAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
        <drugtreatmentduration>96</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523862-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040917</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US10192</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>215</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID (NCH)</medicinalproduct>
        <drugdosagetext>325 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523863-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PPD</medicinalproduct>
        <drugdosagetext>ID/LA</drugdosagetext>
        <drugadministrationroute>023</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PPD</medicinalproduct>
        <drugbatchnumb>C098LPB</drugbatchnumb>
        <drugdosagetext>ID/LA</drugdosagetext>
        <drugadministrationroute>023</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523864-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004MX16229</companynumb>
    <primarysource>
      <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>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISAPRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METROCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELMAC</medicinalproduct>
        <drugdosagetext>12 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELMAC</medicinalproduct>
        <drugdosagetext>6 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523867-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE VESICLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TB TUBERCULIN, PURIFIED PROTEIN DERIVATIVE</medicinalproduct>
        <drugbatchnumb>00ID2P</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523871-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIBRAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523872-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20021122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2002US10075</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>300 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021003</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021107</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523873-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-BRISTOL-MYERS SQUIBB COMPANY-12783494</companynumb>
    <primarysource>
      <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>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACAMPROSATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPIRID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523874-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12911</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>140</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523875-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugdosagetext>ONCE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523876-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12910</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHONCHI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugdosagetext>2 PUFFS/ Q4H</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE</medicinalproduct>
        <drugdosagetext>260 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
        <drugdosagetext>20 MEQ, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugdosagetext>1 PUFF BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.25 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugdosagetext>220 MCG/BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugdosagetext>1.25 MG, Q6H</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>300 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
        <drugdosagetext>500MG Q6H PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523877-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.9488</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAT TISSUE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugdosagetext>2 DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-THYROXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXACILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE/APAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523878-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>35.3806</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugdosagetext>TWICE DAY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CIRCULATORY COLLAPSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523879-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>17.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLEX PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugbatchnumb>P027137</drugbatchnumb>
        <drugdosagetext>1.1 MG ONCE INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523880-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10MG  DAILY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE -ACTONEL-</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHIMAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523881-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040512</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12586194</companynumb>
    <primarysource>
      <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>ESTRACE</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL VALERATE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>OVARIAN FAILURE POSTOPERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATEST H.S.</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523882-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12910</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHONCHI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugdosagetext>2 PUFFS/ Q4H</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE</medicinalproduct>
        <drugdosagetext>260 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
        <drugdosagetext>20 MEQ, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugdosagetext>1 PUFF BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.25 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugdosagetext>220 MCG/BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugdosagetext>1.25 MG, Q6H</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>300 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
        <drugdosagetext>500MG Q6H PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523883-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004CA16962</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BARIUM ENEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONOSCOPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOSCOPY UPPER GASTROINTESTINAL TRACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYPECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523884-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>10-5MG  DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523886-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03598</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523887-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004CA17209</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHOID OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIGMOIDOSCOPY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030411</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523888-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT 25MG</medicinalproduct>
        <drugdosagetext>25MG  BIWEEK SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT 25MG</medicinalproduct>
        <drugdosagetext>25MG  BIWEEK SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523890-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03611</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEMPHIGUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAREG</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040512</drugenddate>
        <drugtreatmentduration>83520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COTAREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIPID METABOLISM DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040717</drugenddate>
        <drugtreatmentduration>124</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAZOL</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ANORECTAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040522</drugenddate>
        <drugtreatmentduration>97920</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCAPRED</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ANORECTAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040512</drugenddate>
        <drugtreatmentduration>83520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANOS</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCIATICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040510</drugenddate>
        <drugtreatmentduration>28800</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC RPG</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCIATICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040521</drugenddate>
        <drugtreatmentduration>96480</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIDREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OGAST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523892-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>ANTIBODY TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DESQUAMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PIGMENTATION CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN  30MG</medicinalproduct>
        <drugdosagetext>30MG  BID SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DEEP VENOUS THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040606</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523899-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12952</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523900-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB03621</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523901-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004JP17161</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRANIAL NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523906-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13098</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>ONE TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523914-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE740002DEC04</companynumb>
    <primarysource>
      <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>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>4782</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523915-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE160028OCT04</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.56</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALCOHOL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMMINUTED FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISLOCATION OF VERTEBRA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB TRAUMATIC AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYNASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523916-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE714101DEC04</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEOXR XR   (VENLFAXINE HYDROCHLORIDE,)</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523917-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE028925OCT04</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>124.85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>37.5 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>37.5 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>50 MG 1X PER 1 DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugdosagetext>50 MG/12.5MG DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POTASSIUM (POTASSIUM, )</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523918-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE717801DEC04</companynumb>
    <primarysource>
      <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 DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523919-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0282287-00</companynumb>
    <primarysource>
      <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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>40147</drugauthorizationnumb>
        <drugdosagetext>200 MG/M2, DAY 1-2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB</medicinalproduct>
        <drugdosagetext>100 MG/D, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugdosagetext>150 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>320 MG/M2, ONCE, INTRAVENOUS BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523920-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0281854-00</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>40147</drugauthorizationnumb>
        <drugdosagetext>200 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB</medicinalproduct>
        <drugdosagetext>100 MG/D, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugdosagetext>150 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>320 MG/M2, ONCE, INTRAVENOUS BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523921-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-601</companynumb>
    <primarysource>
      <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>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523922-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-027671</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040617</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523923-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>206773</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT RANGE OF MOTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON INJURY</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>20040401</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>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTEROL MEDICATION (NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION (NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523924-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000243</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101.6057</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRECANCEROUS CELLS PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY 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>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523925-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>204061</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.9363</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS 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>19980601</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>MULTI-VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523926-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQ9554117DEC2001</companynumb>
    <primarysource>
      <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>ALPHA HAEMOLYTIC STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEPHAROSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMALE REPRODUCTIVE NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHIFT TO THE LEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIMETAPP</medicinalproduct>
        <drugauthorizationnumb>12436</drugauthorizationnumb>
        <drugdosagetext>AS NEEDED, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENTEX LA (GUAIFENESIN/PHENYLPROPANOLAMINE HYDROCHLORIDE,)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUS DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523927-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE187101NOV04</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOAMING AT MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugbatchnumb>A35703</drugbatchnumb>
        <drugauthorizationnumb>18989</drugauthorizationnumb>
        <drugdosagetext>2 TABLETS AS NEEDED, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523928-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9310</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>REFRACTORY ANAEMIA WITH AN EXCESS OF BLASTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>76473</drugauthorizationnumb>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011001</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>76473</drugauthorizationnumb>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>76473</drugauthorizationnumb>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOETIN ALFA</medicinalproduct>
        <drugdosagetext>40000 IU FREQ SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523929-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SUS1-2004-00787</companynumb>
    <primarysource>
      <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>ANTICONVULSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBATROL</medicinalproduct>
        <drugauthorizationnumb>20712</drugauthorizationnumb>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN D.A. (PHENYTOIN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523930-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SUS1-2004-00783</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBATROL</medicinalproduct>
        <drugauthorizationnumb>20712</drugauthorizationnumb>
        <drugdosagetext>300 MG, EVERY 12 HOURS,</drugdosagetext>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>200 MG, EVERY HS,</drugdosagetext>
        <drugindication>IMPULSIVE BEHAVIOUR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>1 MG, 1X/DAY; QD IN AM,</drugdosagetext>
        <drugindication>IMPULSIVE BEHAVIOUR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA SUSPENSION/INJ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523931-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-DE-05750GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANENCEPHALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINA BIFIDA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BROMHEXINE (BROMHEXINE HYDROCHLORIDE) (BROMHEXINE-HCL)</medicinalproduct>
        <drugauthorizationnumb>16402</drugauthorizationnumb>
        <drugdosagetext>IU</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENOTEROL (FENOTEROL HYDROBROMIDE) (FENOTEROL-HBR)</medicinalproduct>
        <drugdosagetext>IU</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORCIPRENALINE (ORCIPRENALINE SULFATE) (ORCIPRENALINE SULFATE)</medicinalproduct>
        <drugdosagetext>IU</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID (ACETYLALICYLIC ACID 'BAYER')</medicinalproduct>
        <drugdosagetext>IU</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523932-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24715</companynumb>
    <primarysource>
      <qualification>3</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>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523933-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24696</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL THROMBOSIS LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>650 MG/M2 Q12H</drugdosagetext>
        <drugindication>RECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523934-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8297</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>89519</drugauthorizationnumb>
        <drugdosagetext>148 MG WEEKLY, IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010504</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugdosagetext>295 MG WEEKLY, IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010504</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugdosagetext>265 MG WEEKLY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010504</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCINE HBR HYT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523935-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW22567</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT RESPULES</medicinalproduct>
        <drugauthorizationnumb>20929</drugauthorizationnumb>
        <drugdosagetext>1 MG BID IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCOLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAXIN XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIQUIBID-D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523936-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24438</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.574</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LENS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
        <drugauthorizationnumb>20746</drugauthorizationnumb>
        <drugdosagetext>TWO SPRAYS EACH NOSTRIL TWICE DAILY</drugdosagetext>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QVAR 40</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523937-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PTWYE258405DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugbatchnumb>M4375B</drugbatchnumb>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>75 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523938-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24506</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523939-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE757114OCT04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugauthorizationnumb>50649</drugauthorizationnumb>
        <drugdosagetext>100 MG 2X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041002</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARNAL (TAMSULOSIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYASPIRINA (ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYONAL (EPERISONE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523940-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04120156</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANT SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSITRON EMISSION TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>50 MG, DAILY, ORAL; 200 MG, DAILY, ORAL; 50 MG, QOD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIGH BLOOD PRESSURE MEDICATION (ANTIHYPERTENSIVES)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523941-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04120142</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</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>20040814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523942-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE764306DEC04</companynumb>
    <primarysource></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>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMTUZUMAB OZOGAMICIN (GEMTUZUMAB OZOGAMICIN, INJECTION)</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>9 MG/M^2 1X PER 1 DAY INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523943-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04070266</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD HUMAN CHORIONIC GONADOTROPIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>400 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040708</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>400 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523944-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE732602DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>150 MG 1X PER 1 DAY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>150 MG 1X PER 1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523945-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-03-MTX-045</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>7.5 MG 1X PER WEEK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG 1 X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILACOR XR (DILIAZEM HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIM CHLORIDE (POTASSIUM CHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDURONYL (DESERPIDINE/METHYCLOTHIAZIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523946-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SEWYE255903DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRE-ECLAMPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523947-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2004A01510</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>124.7392</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</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>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523948-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101354</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugauthorizationnumb>5845</drugauthorizationnumb>
        <drugdosagetext>2 ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RASH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523949-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>REM_00075_2004</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>25.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMODULIN</medicinalproduct>
        <drugauthorizationnumb>21272</drugauthorizationnumb>
        <drugdosagetext>114 NG/KG/MIN CONTINUOUS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523950-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0002452</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHYOL</medicinalproduct>
        <drugauthorizationnumb>20221</drugauthorizationnumb>
        <drugdosagetext>500 MG, 5 IN 1 WK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RADIOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>5-FU (CLUOROURACIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523951-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A03200403954</companynumb>
    <primarysource>
      <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>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>20839</drugauthorizationnumb>
        <drugdosagetext>75 MG QD - ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPTOR - ATORVASTATIN - TABLET - 10 MG</medicinalproduct>
        <drugdosagetext>10 MG QD - ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523952-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A03200403696</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLEXES ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523953-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100800</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.5964</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>20 MG (10 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugdosagetext>1200 MG (1 IN 1 D), UNKNOWN</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523954-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415684BCC</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.0604</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ISCHAEMIC HEART DISEASE PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEART MEDICATIONS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523955-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415294BCC</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
        <drugbatchnumb>284074B</drugbatchnumb>
        <drugdosagetext>60 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN CREAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523956-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414262BCC</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102.0593</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>0020Y</drugbatchnumb>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>440 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523957-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421122BWH</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>EMBOLIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>20304</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523958-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421086BWH</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXBA3J1</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523959-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-035778</companynumb>
    <primarysource>
      <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>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTRAST MEDIA REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>19596</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERSED</medicinalproduct>
        <drugdosagetext>10MG</drugdosagetext>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523960-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE124519OCT04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC FATIGUE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAMILY STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>37.5 MG 2X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040123</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>20 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040117</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523961-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9346</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANIMAL SCRATCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS INFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS PASTEURELLA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE OF IMPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>11719</drugauthorizationnumb>
        <drugdosagetext>15 MG WEEKLY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523962-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2004A01173</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47.6277</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</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>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAVIK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523963-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9349</companynumb>
    <primarysource></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>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>11719</drugauthorizationnumb>
        <drugdosagetext>7.5 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523964-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0072</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS EROSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523965-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9348</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CANDIDA PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANT SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUSARIUM INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DESQUAMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>11719</drugauthorizationnumb>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>1 MG/KG BID</drugdosagetext>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEMTUZUMAB</medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-TRIMOXAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLISTIN SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523966-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ABBOTT-04P-150-0281642-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERGENYL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523967-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040303</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0252109-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>AUTISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL FOOT MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL DYSMORPHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL VALPROATE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL RETARDATION SEVERITY UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIPROPANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523968-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-04P-087-0282331-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPANTIL</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523969-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-10-0465</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93.8946</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MESOTHELIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugdosagetext>X-RAY THERAPY</drugdosagetext>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523970-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE101911OCT04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HILAR LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS, CONTROL FOR SIROLIMUS (TACROLIMUS, CONTROL FOR SIROLIMUS, </medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>2GM AM, 1.5MG PM ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE IN PLASTIC CONTAINER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL (CLOPIDOGREL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL (ALFACALCIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523971-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ABBOTT-04P-150-0281644-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRE-ECLAMPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERGENYL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040911</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523972-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0281920-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPHILUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABUMETONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</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>OMEPRAZOLE</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>TRAMADOL HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523973-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KII-2003-0006462</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>METASTASES TO ABDOMINAL WALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>40 MG, Q12H</drugdosagetext>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523974-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0281920-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABUMETONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</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>OMEPRAZOLE</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>TRAMADOL HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523975-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0281087-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPILIM SYRUP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523976-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE558419NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>18989</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523977-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0281987-00</companynumb>
    <primarysource></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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLATE LYSINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALFUZOSIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOSMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523978-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040920</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0273946-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>500 TO 1000 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FLUINDIONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CEREBRAL ARTERY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523979-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0281775-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</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>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</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>REMEDEINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523980-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ABBOTT-04P-144-0281982-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</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>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACECLOFENAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523981-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004US-00411</companynumb>
    <primarysource>
      <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>ARTERIAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMYTAL SODIUM                      (AMOBARBITAL SODIUM) INJECTION</medicinalproduct>
        <drugdosagetext>100 MG, SINGLE, INTRA-ARTERIAL</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041203</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523982-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>140580USA</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugauthorizationnumb>16793</drugauthorizationnumb>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523983-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0281920-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABUMETONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</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>OMEPRAZOLE</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>TRAMADOL HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523984-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-03P-163-0223219-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.192</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPAREUNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRIP STRENGTH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANASAL SINUS HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS SUPERFICIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURITIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULITIS LUMBOSACRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE ER</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICOPROFEN</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000131</drugenddate>
        <drugtreatmentduration>377</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO 10</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCOCET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990513</drugenddate>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPACET 100</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>15-30 MILLIGRAMS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STRESS SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDRID</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCODAN</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMFENAC SODIUM</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970926</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523985-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>K200401568</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>105.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTRICHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugauthorizationnumb>21301</drugauthorizationnumb>
        <drugdosagetext>QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19740101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugauthorizationnumb>21301</drugauthorizationnumb>
        <drugdosagetext>QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESRADERM PATCH</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523986-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-04P-087-0280548-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN G DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIXED CONNECTIVE TISSUE DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040228</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>L-CARBOCYSTEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040228</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIXED CONNECTIVE TISSUE DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040228</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERAPROST SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPHENIRAMINE MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXTRACT FROM INFLAMMATORY RABBIT SKIN INOCULATED BY VACCINIA VIRUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040228</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523987-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040824</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-04P-013-0271601-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOLIC PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE W/LAMIVUDINE</medicinalproduct>
        <drugdosagetext>600/300 MG BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523988-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ABBOTT-03P-144-0239173-01</companynumb>
    <primarysource></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>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031028</drugenddate>
        <drugtreatmentduration>204</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEFLAZACORT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOLOTIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOLOTIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOLOTIL</medicinalproduct>
        <drugindication>SCIATICA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCIATICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NALIDIXIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCIATICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030613</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCIATICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030610</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugadministrationroute>014</drugadministrationroute>
        <drugindication>OTITIS MEDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugadministrationroute>014</drugadministrationroute>
        <drugindication>JOINT EFFUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXCHLORPHENIRAMINE MALEATE</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>OTITIS MEDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030430</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EBASTINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS MEDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030429</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBROXOL CHLORIDRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS MEDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030503</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMAIC METAMIZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INGUINAL HERNIA REPAIR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030603</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULINDAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030630</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTRIPROPLEEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS MEDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030527</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTOSAN POLYSULFATE SODIUM</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>INJECTION SITE REACTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSPOR</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>OSTEOPOROTIC FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031028</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523989-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0282501-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAVIK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523990-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2004-0017312</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>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOOL ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYMPANIC MEMBRANE PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN ES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523991-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-04P-087-0282392-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITH</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040402</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040402</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-CARBOCISTEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040402</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040330</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROMETHORPHAN HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040330</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROMETHORPHAN HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040402</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBROXOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040330</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLANTAGO HERB EXTRACT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040402</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLEPHEDRINE HYDROCHLORIDE-DL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040402</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523992-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-03P-087-0239299-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVIX CARCINOMA STAGE 0</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030724</drugenddate>
        <drugtreatmentduration>742</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020412</drugenddate>
        <drugtreatmentduration>742</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020607</drugenddate>
        <drugtreatmentduration>742</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020826</drugenddate>
        <drugtreatmentduration>742</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030724</drugenddate>
        <drugtreatmentduration>742</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030724</drugenddate>
        <drugtreatmentduration>594</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020412</drugenddate>
        <drugtreatmentduration>594</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020607</drugenddate>
        <drugtreatmentduration>594</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020826</drugenddate>
        <drugtreatmentduration>594</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAQUINAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030724</drugenddate>
        <drugtreatmentduration>508</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAQUINAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020412</drugenddate>
        <drugtreatmentduration>508</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAQUINAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020607</drugenddate>
        <drugtreatmentduration>508</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAQUINAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020826</drugenddate>
        <drugtreatmentduration>508</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE ENANTATE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>VIRILISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030828</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523993-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0282170-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041203</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523994-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-04P-020-0280479-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PLATELET AGGREGATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AFRIN MOISTURIZING SALINE MIST</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>RHINITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523995-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040920</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ATO-04-0780</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRISENOX</medicinalproduct>
        <drugauthorizationnumb>21248</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523996-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0282400-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATIONS, MIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEGIONELLA INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020501</drugenddate>
        <drugtreatmentduration>577</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523997-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0282114-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
        <drugtreatmentduration>203</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <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>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPACET 100</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARISOPRODOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</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>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523998-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0279403-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.014</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRIGEMINAL NEURALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040805</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4523999-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F01200403723</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LARYNGOSPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN - SOLUTION - 208 MG</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>208 MG Q3W INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE - TABLET - 1650 MG</medicinalproduct>
        <drugdosagetext>1650 MG TWICE DAILY FOR 2 WEEKS, Q3W ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB OR PLACEBO - SOLUTION - 487.5 MG</medicinalproduct>
        <drugdosagetext>487.5 MG Q3W INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TROPISETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524000-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0273543-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPRANAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPRANAVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFABUTIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524001-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-04P-020-0281980-00</companynumb>
    <primarysource></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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524002-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ABBOTT-04P-150-0282598-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</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>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524003-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102771</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524004-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0281954-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47.67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524005-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F01200403801</companynumb>
    <primarysource></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>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN - SOLUTION - 130 MG/M2</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>235 MG Q3W INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE - TABLET - 1800 MG</medicinalproduct>
        <drugdosagetext>1800 MG TWICE A DAY PER ORAL FROM D1 TO D15, Q3W ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524006-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ABBOTT-04P-144-0280241-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS NEUROSENSORY</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>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524007-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-04P-062-0281925-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPERONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>MELPERONE 25</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524008-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040901</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-04P-062-0272237-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITOXIN TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENPROCOUMON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524009-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ABBOTT-04P-144-0282317-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524010-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410748BNE</companynumb>
    <primarysource>
      <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 HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>19537</drugauthorizationnumb>
        <drugdosagetext>250 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524011-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0282401-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA MACROCYTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE W/LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALGANCICLOVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040608</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLATE LYSINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524012-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0281992-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIPOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANNICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKINE CHRONO TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524013-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0279862-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.836</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
        <drugtreatmentduration>616</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAZINE</medicinalproduct>
        <drugdosagetext>2-500MG BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPACET 100</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOLD SHOTS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524014-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410617BFR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL EXAMINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugauthorizationnumb>19537</drugauthorizationnumb>
        <drugdosagetext>750 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SECTRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524015-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1003546</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBULA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN STRIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STARING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIBIA FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYSTAGON</medicinalproduct>
        <drugauthorizationnumb>20392</drugauthorizationnumb>
        <drugdosagetext>400MG QD, THEN 600MG QD, THEN 800MG QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTINOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYSTAGON</medicinalproduct>
        <drugauthorizationnumb>20392</drugauthorizationnumb>
        <drugdosagetext>400MG QD, THEN 600MG QD, THEN 800MG QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTINOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524016-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410322</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
        <drugauthorizationnumb>21275</drugauthorizationnumb>
        <drugindication>OPEN ANGLE GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524020-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-01-0968</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTIMITOCHONDRIAL ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL PROBLEM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugbatchnumb>02K2844</drugbatchnumb>
        <drugauthorizationnumb>19658</drugauthorizationnumb>
        <drugdosagetext>10MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524021-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ACO_0028_2004</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIZANIDINE HCL</medicinalproduct>
        <drugauthorizationnumb>21447</drugauthorizationnumb>
        <drugdosagetext>2 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524022-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040803</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F01200402308</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED SELF-CARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>(OXALIPLATIN)-SOLUTION-100 MG/M2</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>200 MG Q2W, INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040712</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>3000 MG AS 46-HOUR CONTINUOUS, IV INFUSION, INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040714</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>400 MG Q2W, INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040713</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524023-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>800176</companynumb>
    <primarysource>
      <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>ARTIFICIAL ANUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugauthorizationnumb>17512</drugauthorizationnumb>
        <drugdosagetext>INTRAPERITONEAL</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524024-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE03988</companynumb>
    <primarysource>
      <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>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METAMORPHOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISUDYNE</medicinalproduct>
        <drugauthorizationnumb>21119</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040813</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524025-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F01200301348</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULATION TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL OCCULT BLOOD POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS EROSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICES OESOPHAGEAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>(OXALIPLATIN)-SOLUTION-290 MG</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>290 MG, Q3W, INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031021</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>(OXALIPLATIN)-SOLUTION-290 MG</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>290 MG, Q3W, INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031021</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>(CAPECITABINE) - TABLET - 1000 MG/M2</medicinalproduct>
        <drugdosagetext>1000 MG/M2 TWICE A DAY PER ORAL FROM D1 TO D15, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031104</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524026-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-0013</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugauthorizationnumb>19658</drugauthorizationnumb>
        <drugdosagetext>10 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTIDE (FLUTICASONE PROPIONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATENASAL SOLUTION NASAL DROPS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524027-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A01200405896</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>(OXALIPLATIN)-SOLUTION</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>200 MG OTHER, INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524028-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2004A01013</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLORECTAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>15 MG PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>425 MG (1 D), PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCURETIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOBIVON (NEBIVOLOL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524029-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0006</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTERIXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO POSITIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTALLINE    (GENTAMICIN SULFATE) INJECTABLE SOLUTION</medicinalproduct>
        <drugauthorizationnumb>50039</drugauthorizationnumb>
        <drugdosagetext>160 MG INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>OSTEITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTALLINE    (GENTAMICIN SULFATE) INJECTABLE SOLUTION</medicinalproduct>
        <drugauthorizationnumb>50039</drugauthorizationnumb>
        <drugdosagetext>160 MG INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524030-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-10-1106</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AERIUS (DESLORATADINE)    SYRUP</medicinalproduct>
        <drugauthorizationnumb>21165</drugauthorizationnumb>
        <drugdosagetext>10 ML /DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHOTOSENSITIVITY REACTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AERIUS (DESLORATADINE)    SYRUP</medicinalproduct>
        <drugauthorizationnumb>21165</drugauthorizationnumb>
        <drugdosagetext>10 ML /DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524031-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-DE-05986GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIV INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL SOFT TISSUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE (NEVIRAPINE) (NEVIRAPINE)</medicinalproduct>
        <drugauthorizationnumb>20933</drugauthorizationnumb>
        <drugdosagetext>2 MG/KG, PO; ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HUMAN IMMUNODEFICIENCY VIRUS TRANSMISSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOUVIDINE (ZIDOUVIDINE) (SIR)</medicinalproduct>
        <drugdosagetext>4 MG/KG TWICE PER DAY, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HUMAN IMMUNODEFICIENCY VIRUS TRANSMISSION</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524032-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_25443_2004</companynumb>
    <primarysource>
      <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>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
        <drugauthorizationnumb>17794</drugauthorizationnumb>
        <drugdosagetext>1 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>3 G Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAROXYL</medicinalproduct>
        <drugdosagetext>75 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SKENAN</medicinalproduct>
        <drugdosagetext>30 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524034-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0037</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC EMBOLUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAFERONPEG</medicinalproduct>
        <drugdosagetext>120 MCG SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>1000 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODEOXYCHOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524035-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-115255-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESOGESTREL AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>20713</drugauthorizationnumb>
        <drugdosagetext>DF</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON SULFATETHIAMIN COMPOUND TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524036-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-115299-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESOGESTREL AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>20713</drugauthorizationnumb>
        <drugdosagetext>10 DF, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524037-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-CAN-06638-01</companynumb>
    <primarysource>
      <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>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EBIXA (MEMANTINE)</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EBIXA (MEMANTINE)</medicinalproduct>
        <drugdosagetext>5 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EBIXA (MEMANTINE)</medicinalproduct>
        <drugdosagetext>15 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GALANTAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524038-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-DE-05956GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE (NEVIRAPINE) (NEVIRAPINE)</medicinalproduct>
        <drugauthorizationnumb>20636</drugauthorizationnumb>
        <drugdosagetext>INITIAL DOSE OF 200 MG/D FOR 14 DAYS, FOLLOWED BY 200 MG TWICE DAILY, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPIATE (OPIATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524039-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-DEN-07956-01</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPERSONALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRAMIL (CITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>40 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524041-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-CAN-08023-01</companynumb>
    <primarysource>
      <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>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK SECOND DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
        <drugauthorizationnumb>20401</drugauthorizationnumb>
        <drugdosagetext>180 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PINDOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524043-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098554</companynumb>
    <primarysource>
      <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>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>(AS NCESARY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL (CANDESARTAN CILEXETIL)</medicinalproduct>
        <drugdosagetext>16 MG (16 MG, 1 IN 1 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040714</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524045-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-2004-032257</companynumb>
    <primarysource>
      <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>NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugauthorizationnumb>20038</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugauthorizationnumb>20038</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000831</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524046-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12385NB</companynumb>
    <primarysource>
      <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>SUDDEN ONSET OF SLEEP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BI-SIFROL            (PRAMIPEXOLE DIHYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>20667</drugauthorizationnumb>
        <drugdosagetext>1.5 MG, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524047-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2004-034830</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
        <drugdosagetext>30 MG, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEMASTINE FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-DECORTIN-H (PREDNISOLONE SODIUM SUCCINATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524049-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-13001YA</companynumb>
    <primarysource>
      <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HARNAL               (TAMSULOSIN)</medicinalproduct>
        <drugauthorizationnumb>20579</drugauthorizationnumb>
        <drugdosagetext>0.1 MG (0.1 MG QD, PO)  CAPSULES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBAMIPIDE (REBAMIPIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFENIDOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIZOLAM (ETIZOLAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524050-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>240751</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTRAPID (INSULIN HUMAN) SOLUTION FOR INJECTION</medicinalproduct>
        <drugauthorizationnumb>19938</drugauthorizationnumb>
        <drugdosagetext>6 IU, SINGLE</drugdosagetext>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524052-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004080302</companynumb>
    <primarysource>
      <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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELDOX (CAPSULES) (ZIPRASIDONE)</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>80 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524053-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-FF-00687FF</companynumb>
    <primarysource>
      <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>COAGULATION FACTOR DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULAR REGENERATIVE HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL VARICES HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>20636</drugauthorizationnumb>
        <drugdosagetext>400 MG (200MG), PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030130</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGENERASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>...............</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524055-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100366</companynumb>
    <primarysource>
      <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>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPERAZONE (SULBACTAM, CEFOPERAZONE)</medicinalproduct>
        <drugauthorizationnumb>50551</drugauthorizationnumb>
        <drugdosagetext>1 GRAM (1 IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524057-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2004A01004</companynumb>
    <primarysource>
      <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>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROSTAP            (LEUPROLIDE ACETATE)</medicinalproduct>
        <drugauthorizationnumb>20011</drugauthorizationnumb>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-BENELDOPA (MADOPAR)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524059-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100354</companynumb>
    <primarysource>
      <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>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPERAZONE (SULBACTAM, CEFOPERAZONE)</medicinalproduct>
        <drugauthorizationnumb>50551</drugauthorizationnumb>
        <drugdosagetext>1 GRAM, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040116</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524060-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2004A00829</companynumb>
    <primarysource>
      <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 EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>20406</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524062-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004085019</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOR (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524063-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-DE-05759GD</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOCELE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORCIPRENALINE (ORCIPRENALINE SULFATE)</medicinalproduct>
        <drugauthorizationnumb>16402</drugauthorizationnumb>
        <drugdosagetext>IU</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524065-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004014761</companynumb>
    <primarysource>
      <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>ANURIA</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>DIFFERENTIAL WHITE BLOOD CELL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>800 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>600 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE (LEVOMEPROMAZINE)</medicinalproduct>
        <drugdosagetext>25 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE</medicinalproduct>
        <drugdosagetext>125 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNITRAZEPAM (FLUNITRAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE (ZOPICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIZOLAM (ETIZOLAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA LEAF (SENNA LEAF)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAPROTILINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPIRIDE (SULPIRIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VEGETAMIN (CHLORPROMAZINE HYDROCHLORIDE, PHENOBARBITAL, PROMETHAZINE H</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETHANECHOL CHLORIDE (BETHANECHOL CHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOTEROL HYDROBROMIDE (FENOTEROL HYDROBROMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524067-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6011844</companynumb>
    <primarysource>
      <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>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS A ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROX 100 (LEVOTHYROXINE SODIUM)</medicinalproduct>
        <drugauthorizationnumb>76764</drugauthorizationnumb>
        <drugdosagetext>1 DOSAGE FORMS (1 DOSAGE FORMS, 1 IN 1 D), ORAL; YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KERLONE</medicinalproduct>
        <drugdosagetext>20 (20 MG, 1 IN 1 D), ORAL; YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTAZINE           (SPIRONOLACTONE, ALTIZIDE)</medicinalproduct>
        <drugdosagetext>0.5 DOSAGE FORMS (0.5 DOSAGE FORMS, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AERIUS (DESLORATADINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEXAQUINE (TABLETS) (THIAMINE HYDROCHLORIDE, NIAOULI OIL, QUININE BENZ</medicinalproduct>
        <drugdosagetext>2 DOSAGE FORMS; YEARS</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040804</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524069-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20041105807</companynumb>
    <primarysource>
      <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>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS ASEPTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERMOX</medicinalproduct>
        <drugauthorizationnumb>17481</drugauthorizationnumb>
        <drugdosagetext>1 DOSE (S), IN 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524071-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2004GB00456</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE (NGX) (METRONIDAZOLE)</medicinalproduct>
        <drugauthorizationnumb>18740</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>40 UNITS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN (LOSARTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMOL (DEXTROPROPOXYPHENE HYDROCHLORIDE, PARACETAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524072-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CAR 2004-015</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALUMINIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULITIS CERVICAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
        <drugauthorizationnumb>70848</drugauthorizationnumb>
        <drugdosagetext>1G, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040421</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524073-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2004GB00458</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPROLACTINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugauthorizationnumb>70302</drugauthorizationnumb>
        <drugdosagetext>10 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MOOD ALTERED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
        <drugdosagetext>175 - 75 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>37.5 MG, BIW, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYTERTRACYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPICYCLINE (TETRACYCLINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524074-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12594</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CERUMEN IMPACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERTEPORFIN (BATCH #: 01764B)</medicinalproduct>
        <drugauthorizationnumb>21119</drugauthorizationnumb>
        <drugdosagetext>5.4 ML  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHOROIDAL NEOVASCULARISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALDECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE/PARACETAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524075-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040827</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2004ES00440</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN TRIHYDRATE (NGX) (AMOXICILLIN TRIHYDRATE)</medicinalproduct>
        <drugauthorizationnumb>64076</drugauthorizationnumb>
        <drugdosagetext>500 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACTERIAL INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524076-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101080</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524077-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-DE-05980GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRIDOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPRATROPIUM-BROMIDE (IPRATROPIUM BROMIDE) (NR)</medicinalproduct>
        <drugauthorizationnumb>19085</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINNE (MORPHINE) (SEE TEXT) (MORPHINE-HCL)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORAMORPH (MORPHINE SULFATE) (NR) (MORPHINE SULPHATE)</medicinalproduct>
        <drugdosagetext>75 MG  (NR) PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE (FUROSEMIDE) (NR) (FUROSEMIDE)</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM (LORAZEPAM) (NR)  (LORAZEPAM)</medicinalproduct>
        <drugdosagetext>500 MCG  (NR);  3 MG (NR, EVERY 4 HOURS)</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE (CHLORPROMAZINE) (NR)</medicinalproduct>
        <drugdosagetext>100 MG (NR, EVERY 6 HOURS)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYGEN (OXYGEN) (SEE TEXT)</medicinalproduct>
        <drugdosagetext>IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL (HALOPERIDOL) (NR)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524079-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004049712</companynumb>
    <primarysource>
      <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>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>1200 MG (1 D)</drugdosagetext>
        <drugindication>INTERVERTEBRAL DISC PROTRUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMALINE (BELLADONNA EXTRACT, CAFFEINE, OPIUM TINCTURE, PARACETAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524081-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004047673</companynumb>
    <primarysource>
      <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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOSPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTIOUS MONONUCLEOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAL BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MORBILLIFORM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>84349</drugauthorizationnumb>
        <drugdosagetext>200 MG (100 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>1000 MG (500 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021026</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524084-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004240614DE</companynumb>
    <primarysource>
      <qualification>1</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>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERIOSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524087-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004093929</companynumb>
    <primarysource></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>21341</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524089-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099973</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524092-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004094045</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN (1 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COSTOCHONDRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524095-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104185</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORTIS (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524098-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102431</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGEMINAL NEURALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524101-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099920</companynumb>
    <primarysource>
      <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>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>10392</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOXAN LP (DOXAZOSIN) (DOXAZOSIN)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAHISTINE HYDROCHLORIDE (BETAHISTINE HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL (ACENOCOUMAROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524105-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100329</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDURA XL</medicinalproduct>
        <drugauthorizationnumb>19668</drugauthorizationnumb>
        <drugdosagetext>4 MG (4 MG 1 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524110-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100453</companynumb>
    <primarysource>
      <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>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>19950</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040509</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524113-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100287</companynumb>
    <primarysource>
      <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>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPERAZONE (SULBACTAM, CEFOPERAZONE)</medicinalproduct>
        <drugauthorizationnumb>50551</drugauthorizationnumb>
        <drugdosagetext>1 GRAM, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040111</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524115-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100852</companynumb>
    <primarysource>
      <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>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN T INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524117-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101967</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXANTHEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE IV HYPERSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE (LEVOMEPROMAZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524119-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004077317</companynumb>
    <primarysource>
      <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>CUTANEOUS VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>50733</drugauthorizationnumb>
        <drugdosagetext>500 MG (500 MG, DAILY), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524120-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004088789</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>2200 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>125000 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524122-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100059</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</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>VIRACEPT</medicinalproduct>
        <drugauthorizationnumb>20779</drugauthorizationnumb>
        <drugdosagetext>2500 MG (2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE (LAMIVUDINE)</medicinalproduct>
        <drugdosagetext>300 MG (2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE (STAVUDINE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ (EFAVIRENZ)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE W/LAMIVUDINE (LAMIVUDINE, ZIDOVUDINE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE (TENOFOVIR DISPOROXIL FUMARATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTRICITABINE (EMTRICITABINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524124-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004094339</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONONEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugauthorizationnumb>19949</drugauthorizationnumb>
        <drugindication>TINEA INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRATAEGUS EXTRACT (CRATAEGUS EXTRACT)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524128-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05471</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugdosagetext>20 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugdosagetext>200 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTHMODAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DASEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524131-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05081</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugdosagetext>20 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524134-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG01693</companynumb>
    <primarysource></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>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugdosagetext>20 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>300 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DI-ANTALVIC</medicinalproduct>
        <drugdosagetext>6 DF DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG MONTH IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OROCAL D (3)</medicinalproduct>
        <drugdosagetext>1 DF DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524137-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP06050</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugauthorizationnumb>18240</drugauthorizationnumb>
        <drugindication>HYPERTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIAMAZOLE</medicinalproduct>
        <drugindication>HYPERTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524139-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE04543</companynumb>
    <primarysource></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>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DESQUAMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugdosagetext>25 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugdosagetext>50 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>8 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>1120 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524144-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02039</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>TENOSYNOVITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>20578</drugauthorizationnumb>
        <drugdosagetext>10.8 MG Q3MO SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524147-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP03790</companynumb>
    <primarysource></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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>250 MG Q3D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>250 MG Q3D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524149-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP04825</companynumb>
    <primarysource></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>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STROCAIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERDIPINE-LA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC ^FAES^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEANAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRUM ^GREEN CROSS^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VEGA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524152-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02442</companynumb>
    <primarysource>
      <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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEFITINIB</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524154-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE05323</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIC RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIAS</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE:  2MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524156-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003AP04470</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugauthorizationnumb>19726</drugauthorizationnumb>
        <drugdosagetext>80 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugdosagetext>3.6 MG Q4WK SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HONVAN</medicinalproduct>
        <drugdosagetext>500 MG DAILY IVD</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524159-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05873</companynumb>
    <primarysource></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>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
        <drugauthorizationnumb>17970</drugauthorizationnumb>
        <drugdosagetext>20 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>2400 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYSRON</medicinalproduct>
        <drugdosagetext>800 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>50 MG DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FURTULON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524161-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW18655</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUDESONIDE + FORMOTEROL (SYMBICORT)</medicinalproduct>
        <drugdosagetext>160/4.5 MCG/INH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040413</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524164-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>062-20785-04120151</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE - PHARMION (THALIDOMIDE)</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPIOIDES (OPIAT)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524166-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>028-20785-04070512</companynumb>
    <primarysource>
      <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>BLOOD HUMAN CHORIONIC GONADOTROPIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugbatchnumb>0173X</drugbatchnumb>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugbatchnumb>0173X</drugbatchnumb>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524170-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-00616</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECEREBRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL FUNCTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.70 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACE INHIBITOR NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524175-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-00735</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</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>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.50 MG  2/WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN (OXYCODON HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524179-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-00807</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>4BD004</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.21 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524182-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>J081-002-001818</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SICK SINUS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</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</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENIVEZE (ENALPARIL MALEATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAMALIL (TIAPRIDE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524185-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A044-002-005345</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugdosagetext>20 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524188-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A044-002-005337</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>10 + 20 MG,  1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>10 + 20 MG,  1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524191-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D01200400460</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>74735</drugauthorizationnumb>
        <drugdosagetext>80 MG/M2 CONT - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER EXTENSIVE STAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>120 MG/M2 GIVEN ON DAYS 1, 2 AND 3, IN A 30-MINUTE INFUSION - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER EXTENSIVE STAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOLE MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524194-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D01200400190</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOPULMONARY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>74735</drugauthorizationnumb>
        <drugdosagetext>80 MG/M2 CONT - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER EXTENSIVE STAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>120 MG/M2 GIVEN ON DAYS 1, 2 AND 3, IN A 30MINUTE INFUSION - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER EXTENSIVE STAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN HUMAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPHANE INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE SODIUM SUCCINATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524195-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-0007806</companynumb>
    <primarysource>
      <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>CRANIAL NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugauthorizationnumb>21449</drugauthorizationnumb>
        <drugdosagetext>8 MONTHS PRIOR TO EVENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEFFIX       (LAMIVUDINE)</medicinalproduct>
        <drugdosagetext>1.5 YEAR PRIOR TO EVENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>MCG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524196-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100567</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PSEUDOEPHEDRINE                   (PSEUDOEPHEDRINE)</medicinalproduct>
        <drugauthorizationnumb>73585</drugauthorizationnumb>
        <drugdosagetext>60 MG ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524197-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100570</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE DIASTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PSEUDOEPHEDRINE (PSEUDOEPHEDRINE)</medicinalproduct>
        <drugauthorizationnumb>73585</drugauthorizationnumb>
        <drugdosagetext>300 MG ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524198-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100569</companynumb>
    <primarysource>
      <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>ANGIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PSEUDOEPHEDRINE (PSEUDOEPHEDRINE)</medicinalproduct>
        <drugauthorizationnumb>73585</drugauthorizationnumb>
        <drugdosagetext>1 TABLET 60 MG QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524199-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100571</companynumb>
    <primarysource>
      <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>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PSEUDOEPHEDRINE HCL</medicinalproduct>
        <drugauthorizationnumb>73585</drugauthorizationnumb>
        <drugdosagetext>180 MG ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524200-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101557</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524201-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099922</companynumb>
    <primarysource>
      <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>ABDOMINAL DISCOMFORT</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 LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugauthorizationnumb>19835</drugauthorizationnumb>
        <drugdosagetext>10 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXATOMIDE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524202-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099232</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FELDENE</medicinalproduct>
        <drugauthorizationnumb>18147</drugauthorizationnumb>
        <drugdosagetext>(20 MG/ML, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETORICOXIB (ETORICOXB)</medicinalproduct>
        <drugdosagetext>60 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIOCOLCHICOSIDE (THIOCOLOCHICOSIE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524204-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097851</companynumb>
    <primarysource>
      <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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20882</drugauthorizationnumb>
        <drugdosagetext>300 MG (100 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET (MARBIDOPA, LEVODOPA)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERRAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE (PANTOPRAZOLE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524205-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AC00381</companynumb>
    <primarysource>
      <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>AORTIC ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BETA HAEMOLYTIC STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS NECROTISING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EZETROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORUNO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KREDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BURINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND 8</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRACETAM 1200</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT AEROSOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMID-RADIOPHARM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIFLONIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524207-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AC00863</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>20 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROVEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELTHYRONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLENDIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524209-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24721</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524211-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AC00396</companynumb>
    <primarysource>
      <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>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</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>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CONSOLIDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESUSCITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugauthorizationnumb>12704</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524212-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24443</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>25 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>100 MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELTROXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBICOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524214-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ABBOTT-04P-083-0282314-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524215-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0282474-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIVALPROEX SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ALCOHOL USE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALCOHOL WITHDRAWAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>TREMOR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>AGITATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524216-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24590</companynumb>
    <primarysource>
      <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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>400 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>25 MG DAILY GE</drugdosagetext>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524218-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02569</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>20541</drugauthorizationnumb>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEFITINIB CODE NOT BROKEN</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE ^APS^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL-D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524219-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02396</companynumb>
    <primarysource>
      <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>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugauthorizationnumb>20441</drugauthorizationnumb>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYOSTACINE</medicinalproduct>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECTOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524220-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0281993-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKRINOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEDATIVE THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524221-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-0883</companynumb>
    <primarysource>
      <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>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN SULFATE</medicinalproduct>
        <drugauthorizationnumb>50039</drugauthorizationnumb>
        <drugdosagetext>120 MG INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM INJECTABLE SOLUTION</medicinalproduct>
        <drugdosagetext>36 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSFLUCONAZOLE (FLUCONAZOLE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524222-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1660</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>2.8</patientweight>
      <reaction>
        <reactionmeddrapt>COARCTATION OF THE AORTA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ATRESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AERIUS (DESLORATADINE) 'LIKE CLARINEX'</medicinalproduct>
        <drugauthorizationnumb>21165</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE (SALMETEROL XINAFOATE/FLUTICASONE PROPIONAT</medicinalproduct>
        <drugdosagetext>2 DOSES QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BERODUAL</medicinalproduct>
        <drugdosagetext>TID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZADITEN</medicinalproduct>
        <drugdosagetext>2 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLIXONASE (FLUTICASONE PROPIONATE) NASAL AEROSOL</medicinalproduct>
        <drugdosagetext>1 PUFF QD IN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELFAST (FEXOFENADINE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524223-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1686</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELESTENE (BETAMETHASONE) ORAL SOLUTION</medicinalproduct>
        <drugauthorizationnumb>14215</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524224-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-0884</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUTTOCK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RINDERON TABLETS</medicinalproduct>
        <drugauthorizationnumb>14215</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAPLASTIC ASTROCYTOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RINDERON TABLETS</medicinalproduct>
        <drugauthorizationnumb>14215</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAPLASTIC ASTROCYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE CAPSULES</medicinalproduct>
        <drugdosagetext>195 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAPLASTIC ASTROCYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESILATE TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX CAPSULES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID TABLETS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524225-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210823</companynumb>
    <primarysource>
      <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>DUODENAL ULCER PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>SINGLE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOTHERAPY (ANTIGEN) (ALLERGENIC EXTRACTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEHYDROCODEINUM (DIHYDROCODEINE BITARTRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPIUM TINCTURE (OPIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVOBAN (TROPISETRON HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVEGIL (CLEMASTINE FUMARATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524226-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210908</companynumb>
    <primarysource>
      <qualification>3</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>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM PR SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN (DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524227-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004VX000923</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESTINON</medicinalproduct>
        <drugauthorizationnumb>9829</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYASTHENIA GRAVIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>MYASTHENIA GRAVIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EGAZIL DURETTER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE ^NM PHARMA^</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524228-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OMPQ-NO-0411S-1363</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugauthorizationnumb>18956</drugauthorizationnumb>
        <drugdosagetext>160 ML, SINGLE DOSE, I.A.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ARTERIAL INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugauthorizationnumb>18956</drugauthorizationnumb>
        <drugdosagetext>160 ML, SINGLE DOSE, I.A.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CEREBROVASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM LACTATE, POTASSIUM CHLORIDE (LOW MOLECULAR DEXTRAN L)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE, AMINO ACIDS NOS, ELECTROLYTES NOS (AMINOFLUID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD, CALF, DEPROT., LMW PORTION (SOLCOSERYL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLOFENOXATE HYDROCHLORIDE (LUCIDRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITICOLINE (NICHOLIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCINE MAX SEED OIL (INTRALIPOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFMETAZOLE SODIUM (CEFMETAZON)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM (EPIRENAT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN (ALEVIATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICERGOLINE (SALUMOSIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524649-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0412USA00582</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>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DESQUAMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOCIN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFCAPENE PIVOXIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PONTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFACLOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524650-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA03465</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER PYLORI IDENTIFICATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THERAPEUTIC PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040515</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
        <drugtreatmentduration>143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
        <drugtreatmentduration>143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040614</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524651-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0411GBR00169</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PEMPHIGOID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEMPHIGUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040621</drugenddate>
        <drugtreatmentduration>77</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524652-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0412GBR00035</companynumb>
    <primarysource>
      <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>FAHR'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524653-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-0411ESP00002</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETIT MAL EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHIAL HYPERACTIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BRONCHIAL HYPERACTIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BRONCHIAL HYPERACTIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PETIT MAL EPILEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524654-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0412USA00420</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021026</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021104</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021210</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021218</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021026</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021104</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021210</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021218</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021026</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021104</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021210</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021218</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524655-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0412FRA00015</companynumb>
    <primarysource>
      <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>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040515</drugenddate>
        <drugtreatmentduration>258</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE SODIUM SUCCINATE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040223</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSYNTROPIN</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040223</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524656-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0301USA02085</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST WALL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COSTOCHONDRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED ACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBULA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL FUNCTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATIC FEVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL ODOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VEIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEO-BI-FLEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HOT FLUSH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030103</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524657-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA03466</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OSTEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VOGT-KOYANAGI-HARADA SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524658-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA02990</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524659-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00070</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</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>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040617</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524660-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA01687</companynumb>
    <primarysource>
      <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>LUMBAR VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021127</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARNAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVAMIN (PROCHLORPERAZINE MESYLATE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031220</drugenddate>
        <drugtreatmentduration>1005</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC EFFECT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031220</drugenddate>
        <drugtreatmentduration>1005</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031220</drugenddate>
        <drugtreatmentduration>1005</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031220</drugenddate>
        <drugtreatmentduration>1005</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524661-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA01013</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCUMORAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524662-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020417</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0204USA02050</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCAL SWELLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524663-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0412USA00629</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MENINGITIS ASEPTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524664-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0304USA00832</companynumb>
    <primarysource>
      <qualification>3</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN VASCULAR NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVERSION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GANGLION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENOPAUSAL SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE WITH AURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANNICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOSOMATIC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORTICOLLIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AEROBID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19681217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19630611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030810</drugenddate>
        <drugtreatmentduration>14671</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524665-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20000112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-00010882</companynumb>
    <primarysource>
      <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>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVE INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991201</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991201</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524666-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0402USA01051</companynumb>
    <primarysource>
      <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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL TINEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040127</drugenddate>
        <drugtreatmentduration>821</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEANAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524667-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0412FRA00016B1</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>-14</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGOHYDRAMNIOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL AGENESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524668-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0412FRA00016M</companynumb>
    <primarysource>
      <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>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGOHYDRAMNIOS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524669-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00614</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID BRUIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLAUSTROPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERMITTENT CLAUDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAMMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMAL PRESSURE HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINITIS TRICHOMONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011009</drugenddate>
        <drugtreatmentduration>677</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRENTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AQUAPHOR OINTMENT</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRY SKIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524670-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00857</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524671-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00759</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>120</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACQUIRED DIAPHRAGMATIC EVENTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIAPHRAGMATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000510</drugenddate>
        <drugtreatmentduration>405</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001102</drugenddate>
        <drugtreatmentduration>573</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010225</drugenddate>
        <drugtreatmentduration>322</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010927</drugenddate>
        <drugtreatmentduration>214</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TALWIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010927</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010912</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011010</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011011</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010201</drugenddate>
        <drugtreatmentduration>536</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010901</drugenddate>
        <drugtreatmentduration>214</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010201</drugenddate>
        <drugtreatmentduration>536</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010901</drugenddate>
        <drugtreatmentduration>214</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524672-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00728</companynumb>
    <primarysource>
      <qualification>1</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURED COCCYX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOARSENESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEBORRHOEIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKELETAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PAPILLOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524673-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00712</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID BRUIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIDIDYMAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL FUNCTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524674-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00786</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>129</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC OUTLET OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-CARDIAC CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REGURGITATION OF FOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTRICTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR WALL THICKENING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524675-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00788</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER IN SITU</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHONDROMALACIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL TRACT ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE BODY IN JOINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO POSITIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORGARD</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRAX CAPSULES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTINEOPLASTIC (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524676-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00813</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>111</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COSTOCHONDRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL OCCULT BLOOD POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524677-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00802</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULAR PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURICEF</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990823</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524678-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00816</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM POOR R-WAVE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESSENTIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOLLICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEARFULNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010228</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524679-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030414</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0304USA01437</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010326</drugenddate>
        <drugtreatmentduration>532</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELOCON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE PAMOATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURATUSS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIPEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE CITRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524680-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0311USA02557</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENOPAUSAL SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL DRYNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSMENORRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001125</drugenddate>
        <drugtreatmentduration>257</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001125</drugenddate>
        <drugtreatmentduration>257</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MITRAL VALVE PROLAPSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NERVOUSNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001125</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524681-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0312USA01725</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PAPILLOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524682-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00934</companynumb>
    <primarysource>
      <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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANEURYSM RUPTURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICITIS PERFORATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFAECATION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIANAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIRECTAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOPERITONEUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS ANI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524683-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00925</companynumb>
    <primarysource>
      <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 ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERIAL EMBOLUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID BRUIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCHROMIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PERITONEAL ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTEBRAL ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPONDYLITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010624</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524684-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040219</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0402USA01452</companynumb>
    <primarysource>
      <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>ACUTE SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS EROSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMATOSIS CYSTOIDES INTESTINALIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021114</drugenddate>
        <drugtreatmentduration>1218</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROPIPATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031114</drugenddate>
        <drugtreatmentduration>3956</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRIXORAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</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>MAGNESIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524685-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00885</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>ABDOMINAL ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE MB INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISIONAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNORING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524686-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00882</companynumb>
    <primarysource>
      <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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHONDROMALACIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KERATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPETROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESIC OR ANESTHETIC (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MURO 128 OPHTHALMIC OINTMENT</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIFICIAL TEARS</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524687-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040226</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0402USA01953</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL WALL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS NECK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAN MYOCARDIAL PERFUSION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEBORRHOEIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TELANGIECTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENOSYNOVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020126</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524688-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040611</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0406USA01553</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INGUINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL EXAMINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN-D</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROSTATIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLENDIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524689-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00049</companynumb>
    <primarysource>
      <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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </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>DETROL LA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VAGIFEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524690-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA01026</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524691-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03003</companynumb>
    <primarysource>
      <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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524692-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041008</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00266</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ROTATOR CUFF SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILIBININ</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYNARA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524693-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03589</companynumb>
    <primarysource>
      <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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY ATHEROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPEN WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040527</drugenddate>
        <drugtreatmentduration>557</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040527</drugenddate>
        <drugtreatmentduration>557</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-ESTRADIOL</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL MSD LP</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGYRAX (MECLIZINE HYDROCHLORIDE)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PNEUMOVAX (PNEUMOCOCCAL 14V POLYSACCHARIDE VACCINE)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524694-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03966</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONNECTIVE TISSUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROBID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524695-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0411AUS00240</companynumb>
    <primarysource>
      <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>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARPAL TUNNEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND CODEINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524696-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00486</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE IMMEASURABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPORAL ARTERITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL XINAFOATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524697-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA04251</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>114</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METATARSALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EXOSTOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524698-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA02966</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROSCOPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL NERVE TRANSPOSITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524699-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00080</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524700-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00242</companynumb>
    <primarysource>
      <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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010917</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524701-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00260</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524702-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA02530</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524703-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA02319</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524704-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA01045</companynumb>
    <primarysource>
      <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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TENDONITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524705-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00316</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524706-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0412GBR00054</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524707-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-MERCK-0412SWE00010</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524708-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00313</companynumb>
    <primarysource>
      <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524709-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00447</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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040208</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIMBITROL TABLETS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524710-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00631</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COSTOCHONDRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAINFUL RESPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULCERIN (CIMETIDINE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULCERIN (CIMETIDINE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGYRAX (MECLIZINE HYDROCHLORIDE)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGYRAX (MECLIZINE HYDROCHLORIDE)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOPHYLLINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524711-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00722</companynumb>
    <primarysource>
      <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[COMPOSITION UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524712-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00523</companynumb>
    <primarysource>
      <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>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524713-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00558</companynumb>
    <primarysource>
      <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990922</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524714-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00650</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524715-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04267</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524716-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03250</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>123</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLENDIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524717-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00630</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>107</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL ABRASION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACK DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991201</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUDAFED S.A.</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COUGH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524718-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00307</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524719-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00504</companynumb>
    <primarysource>
      <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>1369</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524720-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00508</companynumb>
    <primarysource>
      <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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
        <drugtreatmentduration>367</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524721-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00425</companynumb>
    <primarysource>
      <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>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY RESTENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524722-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00381</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACK DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524723-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524724-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00730</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARPAL TUNNEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524725-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041211</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00432</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524726-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-RB-1173-2004</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>1 DOSE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGEAL CANDIDIASIS</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGEAL CANDIDIASIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDINAVIR SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OESOPHAGEAL CANDIDIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524728-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041006164</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GANGLION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
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      <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>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEO</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEO</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEO</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEO</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524729-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041200195</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524730-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041200442</companynumb>
    <primarysource>
      <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>PSORIASIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4524731-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041200445</companynumb>
    <primarysource>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>68.27</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOVENOUS MALFORMATION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>04G013A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4524732-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041201645</companynumb>
    <primarysource>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMYLOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <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>RHEUMATOID ARTHRITIS</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KELNAC</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524733-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20041003337</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMCONCOR</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRAMIL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZOLAN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAMET</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524734-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NSADSS2003012792</companynumb>
    <primarysource>
      <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>HISTOPLASMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524735-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>K200401809</companynumb>
    <primarysource>
      <qualification>3</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>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAB</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>19901</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERVOXAN (VINBURNINE) CAPSULE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEMIGOXINE NATIVELLE (DIGOXIN) TABLET</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN (PREVISCAN)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTOXIFYLLINE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRESERVISION (DIETARY SUPPLEMENTS)() 4 U</medicinalproduct>
        <drugdosagetext>4 U, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040417</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524737-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>K200401844</companynumb>
    <primarysource>
      <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>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLINERGIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEMADRIN (PROCYCLIDINE) TABLET, 15MG</medicinalproduct>
        <drugauthorizationnumb>9818</drugauthorizationnumb>
        <drugdosagetext>15 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>5 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BESITRAN (SERTRALINEHYDROCHLORIDE) TABLET, 300 MG</medicinalproduct>
        <drugdosagetext>300 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROVEL (IRBESARTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAMET (LORMETAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM (NICOUMALONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524740-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>K200401841</companynumb>
    <primarysource>
      <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>ASPHYXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTAL</medicinalproduct>
        <drugbatchnumb>A30061D</drugbatchnumb>
        <drugauthorizationnumb>18887</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTAL</medicinalproduct>
        <drugbatchnumb>A30061D</drugbatchnumb>
        <drugauthorizationnumb>18887</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOFORTE (BECLOMETASONE DIPROPIONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-HISTAMINE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524742-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AZAFR200400214</companynumb>
    <primarysource>
      <qualification>1</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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CREPITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugauthorizationnumb>50794</drugauthorizationnumb>
        <drugdosagetext>75 MG/M2 (100 MG, DAILY X 7 DAYS), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040926</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524744-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-600</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEGIONELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>15 MG 1 X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>40 MG 2 X PER 1 MTH, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524745-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-599</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA MYCOPLASMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>2 MG 1 X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>4 MG 1 X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>6 MG 1 X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARFENIL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524746-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-598</companynumb>
    <primarysource>
      <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>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>7.5 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524747-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-360</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG 2 X PER 1 WK, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524748-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20041005909</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR PSEUDOANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugbatchnumb>03330822</drugbatchnumb>
        <drugdosagetext>04.4 ML IN 050 ML DILUENT AT 04.1 ML/H</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugbatchnumb>03330822</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE</medicinalproduct>
        <drugbatchnumb>04330030</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524749-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040909135</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524750-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041201310</companynumb>
    <primarysource>
      <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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIHEXYPHENIDYL HCL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524751-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040501364</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PROLACTIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALACTORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC POLYPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFERTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITUITARY TUMOUR BENIGN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020901</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524752-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041200425</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEVASE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524753-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20041106660</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugbatchnumb>03330822</drugbatchnumb>
        <drugdosagetext>05.0 ML IN 050 ML DILUENT AT 04.0 ML/H</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugbatchnumb>03330822</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE</medicinalproduct>
        <drugbatchnumb>04330030</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACE INHIBITOR NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524754-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>240636</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugauthorizationnumb>20986</drugauthorizationnumb>
        <drugdosagetext>24 IU, QD, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID FLEXPEN (INSULIN ASPART) SOLUTION FOR INJECTION, 100U/ML</medicinalproduct>
        <drugdosagetext>36 IU, QD, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STESOLID (DIAZEPAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524755-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12754685</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>WARFARIN DECREASED TO 35 MG WEEKLY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524756-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12780573</companynumb>
    <primarysource>
      <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>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARATHYROID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARATHYROID TUMOUR BENIGN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>SUBSTITUTION WITH CALCIPARINE ON 30-SEP-2004</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIPARINE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524757-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040422</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12567707</companynumb>
    <primarysource>
      <qualification>3</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABATACEPT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALAGEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19681001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524758-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-12779849</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031028</drugenddate>
        <drugtreatmentduration>1</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>20031028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031028</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031028</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANEF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANEF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTMONORM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTMONORM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMAZOLE</medicinalproduct>
        <drugindication>HYPERTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031028</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031028</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENISTIL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031028</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031028</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524759-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040427</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12579025</companynumb>
    <primarysource>
      <qualification>3</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFUSE LARGE B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOSPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABATACEPT</medicinalproduct>
        <drugdosagetext>BLINDED THERAPY STARTED ON 02-MAY-2001</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELAFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040418</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524760-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12786083</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>GERM CELL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugindication>GERM CELL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugindication>GERM CELL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524761-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-12779849</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031028</drugenddate>
        <drugtreatmentduration>1</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>20031028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031028</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031028</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANEF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANEF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTMONORM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTMONORM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMAZOLE</medicinalproduct>
        <drugindication>HYPERTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031028</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031028</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENISTIL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031028</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031028</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524762-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>240785</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID 30 MIX CHU FLEXPEN (INSULIN ASPART) SUSPENSION FOR INJECTION</medicinalproduct>
        <drugauthorizationnumb>21172</drugauthorizationnumb>
        <drugdosagetext>8 IU, QD, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID CHU (INSULIN ASPART) SOLUTION FOR INJECTION, 100U/ML</medicinalproduct>
        <drugdosagetext>5 - 14 IU QD, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTRIA (TRICHLORMETHIAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KINEDAK (EPALRESTAT)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524763-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>240733</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN DETEMIR</medicinalproduct>
        <drugauthorizationnumb>20986</drugauthorizationnumb>
        <drugdosagetext>36 U, QD, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID (INSULIN ASPART) SOLUTION FOR INJECTION, 100U/ML</medicinalproduct>
        <drugdosagetext>58 IU, QD, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524764-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SGB1-2004-00438</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>1.4</patientweight>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGRYLIN</medicinalproduct>
        <drugauthorizationnumb>20333</drugauthorizationnumb>
        <drugdosagetext>4 MG DAILY; 1MG</drugdosagetext>
        <drugindication>ESSENTIAL THROMBOCYTHAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524765-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040902</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ATO-04-0798</companynumb>
    <primarysource>
      <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>TRISENOX</medicinalproduct>
        <drugauthorizationnumb>21248</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524766-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2004-035724</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>19596</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>ANGIOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>19596</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>ANGIOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONTRAST MEDIA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524767-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-2004-032006</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSPASM CORONARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>19596</drugauthorizationnumb>
        <drugdosagetext>11 ML, 1 DOSE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524768-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-10854</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>I MG/KG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524769-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-FF-00555FF</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugdosagetext>40 MG (40 MG), PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524770-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-09778AU</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugdosagetext>18 MCG (18 MCG, 1 DAILY), IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL (PERINDOPRIL) (TA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524771-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-ES-00230ES</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugauthorizationnumb>21527</drugauthorizationnumb>
        <drugdosagetext>(20 MCG, 3 IH/6H) ,IH ; ONCE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL (SALMETEROL) (AE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE (FLUTICASONE) (AE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEGURIL (FUROSEMIDE) (TA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524772-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NLWYE170203NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>75 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524773-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SEWYE255903DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRE-ECLAMPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524774-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE705612OCT04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACINETOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST WALL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
        <drugtreatmentduration>718</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524775-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE243430NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOCILLINE (PIPERACILLIN/TAZOBACTAM, INJECTION)</medicinalproduct>
        <drugauthorizationnumb>50684</drugauthorizationnumb>
        <drugdosagetext>4.5 G X 2X PER 1 DAY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHOPNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX (LINEZOLID, 0)</medicinalproduct>
        <drugdosagetext>600 MG 2X PER 1 DAY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHOPNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPASFON (PHLOROGLUCINOL/TRIMETHYLPHLOROGLUCINOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYTONADIONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSOLVAN-200 (URSODEOXYCHOLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B (VITAMIN B)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524776-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE237526NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN FISSURES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>1 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>11 G 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>75 MG 2X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
        <drugtreatmentduration>438</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>40 MG 2X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARMIDEX (ANASTROZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM (BROMAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERCIAN (GYAMEMAZINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524777-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SGB1-2004-00434</companynumb>
    <primarysource></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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRE-ECLAMPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGRYLIN</medicinalproduct>
        <drugauthorizationnumb>20333</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>THROMBOCYTOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524778-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-122507-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN-FRACTION, SODIUM SALT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKINE CHRONO /CZE/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEHYDRO SANOL TRI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETILEPRINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEET PHOSPHO SODA SOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINOMEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALIZAPRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTIMEL VANILLA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERFUSALGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICONAZOLE NITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMEFREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROPUNDIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFUROXIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGFILGRASTIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524779-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-122956- NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS NEUROSENSORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESBYACUSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>15 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>15 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524780-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TOR 2004-0030</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FARESTON</medicinalproduct>
        <drugauthorizationnumb>20497</drugauthorizationnumb>
        <drugdosagetext>120 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIFLURIDINE</medicinalproduct>
        <drugdosagetext>800 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040910</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL HYDRATE</medicinalproduct>
        <drugdosagetext>90 MG INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040823</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524781-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-DE-05758GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANENCEPHALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULATION DISORDER NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORCIPRENALINE (ORCIPRENALINE  SULFATE) (NR) (ORCIPRENALINE  SULFATE)</medicinalproduct>
        <drugauthorizationnumb>16402</drugauthorizationnumb>
        <drugdosagetext>IU</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524782-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-ES-00229ES</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugauthorizationnumb>21527</drugauthorizationnumb>
        <drugdosagetext>(20 MCG, 3 IH/6H) IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORMOTEROL (FORMOTEROL) (AE) (TOLIPROLOL-HCL, DIPYRIDAMOLE-HCL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE (FLUTICASONE) (AE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE (THEOPHYLLINE) (KA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORASEMIDE (TORASEMIDE) (KA)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524783-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-DE-05331DE</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST INTERFERENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
        <drugauthorizationnumb>21162</drugauthorizationnumb>
        <drugdosagetext>STRENGTH:  80MG TELMISARTAN, 12.5MG HYDROCHLOROTHIAZID (SEE TEXT) PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC (NR)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524784-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-DE-06101BY</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
        <drugauthorizationnumb>21162</drugauthorizationnumb>
        <drugdosagetext>80 MG (NR) PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFEXIN (CEFALEXIN MONOHYDRATE) (NR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMAL (NR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND (CANDESARTAN CILEXETIL) (NR)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524785-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200311372JP</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BASE EXCESS 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 LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEASLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KELNAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLETON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524786-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413490JP</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APLACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASLON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE-ALPHA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON DEFICIENCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524787-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031205</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200311471JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>DOSE: 8MG/WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTEBAN</medicinalproduct>
        <drugdosagetext>DOSE: 50-75</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONALON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC /JPN/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERSANTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAZEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUZYM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYDOXAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524788-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413230JP</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44.2</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 CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524789-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041008</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200417720US</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>STENT PLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524790-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VIS10176.2004</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.3273</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL OCCULT BLOOD POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABYRINTHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROCALCINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREPYLORIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISICOL</medicinalproduct>
        <drugauthorizationnumb>21097</drugauthorizationnumb>
        <drugdosagetext>48 G QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLONOSCOPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugindication>ANTIINFLAMMATORY THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGIOTENSIN CONVERTING ENZYME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBENECID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524791-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020913</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0002489</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHYOL</medicinalproduct>
        <drugauthorizationnumb>20221</drugauthorizationnumb>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RADIOTHERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524792-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0002492</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHYOL</medicinalproduct>
        <drugauthorizationnumb>20221</drugauthorizationnumb>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021021</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524793-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20021120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0002495</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DESQUAMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHYOL</medicinalproduct>
        <drugauthorizationnumb>20221</drugauthorizationnumb>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524794-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030821</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0002503</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHYOL</medicinalproduct>
        <drugauthorizationnumb>20221</drugauthorizationnumb>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524795-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030804</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0002493</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHYOL</medicinalproduct>
        <drugauthorizationnumb>20221</drugauthorizationnumb>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RADIOTHERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524796-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0002486</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHYOL</medicinalproduct>
        <drugauthorizationnumb>20221</drugauthorizationnumb>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RADIOTHERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524797-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-USFACT00054</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FACTIVE</medicinalproduct>
        <drugauthorizationnumb>21158</drugauthorizationnumb>
        <drugdosagetext>QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION BACTERIAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524798-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1000110</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.4514</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HYPOGAMMAGLOBULINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXANDRIN</medicinalproduct>
        <drugauthorizationnumb>13718</drugauthorizationnumb>
        <drugdosagetext>5 MG;QD;PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAROXOLYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAPLEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524799-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04020740</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CD4 LYMPHOCYTES DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL LINE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMMUNICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL VOLUME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STARING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID (THALIDOMIDE) (50 MILLIGRAM, CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>150-200 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>650 MG, X4D, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>65 MG, X4D, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>65 MG, X4D, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031222</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524800-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004DE16369</companynumb>
    <primarysource>
      <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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SMEAR TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREE HAEMOGLOBIN PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC URAEMIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASMAPHERESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALTEPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOLSIDOMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524801-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04120142</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID (THALIDOMIDE) (50 MILLIGRAM, CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524802-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04060266</companynumb>
    <primarysource>
      <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>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID (THALIDOMIDE) (50 MILLIGRAM, CAPSULES)</medicinalproduct>
        <drugbatchnumb>0211W</drugbatchnumb>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>50 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524803-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04110626</companynumb>
    <primarysource></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>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524804-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04120053</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524805-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040818</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BR10918</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPLICTIL</medicinalproduct>
        <drugdosagetext>100 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040816</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELLARIL</medicinalproduct>
        <drugdosagetext>100 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040816</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELLARIL</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENERVA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524806-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2223</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINIC ACID DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugbatchnumb>58007D</drugbatchnumb>
        <drugauthorizationnumb>87425</drugauthorizationnumb>
        <drugdosagetext>300MG  1/DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524807-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04110123</companynumb>
    <primarysource>
      <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>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID (THALIDOMIDE) (50 MILLIGRAM, CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MG, AT BEDTIME, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524808-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-0007123</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AIDS ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EARLY SATIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIUM AVIUM COMPLEX INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS RELAPSING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MORBILLIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugauthorizationnumb>21356</drugauthorizationnumb>
        <drugdosagetext>300 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (THOMAPYRIN N)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIREX (SUMATRIPTAN SUCCINATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBENECID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524809-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D01200404475</companynumb>
    <primarysource></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>ANTI-HBS ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY RELATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASBURICASE - SOLUTION</medicinalproduct>
        <drugdosagetext>0.2 MG/KG - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524810-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200420734BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FAT EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugauthorizationnumb>19537</drugauthorizationnumb>
        <drugdosagetext>500 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANDIDURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugauthorizationnumb>19537</drugauthorizationnumb>
        <drugdosagetext>500 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524811-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BR16309</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>803</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASPHYXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE VIA BREAST MILK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO PAIN STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINOSORO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524812-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421094BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524813-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>118</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMTAN</medicinalproduct>
        <drugdosagetext>200 MG 5 TIMES DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE SYMMETREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524814-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.3075</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIRIONAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIROSETH</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524816-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.0906</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>50MG  QAM  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>300 MG QHS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE NA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISACODYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APAP TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE NA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524818-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE  50</medicinalproduct>
        <drugdosagetext>50MG  BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524819-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>500MG INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHYTONADIONE</medicinalproduct>
        <drugdosagetext>10MG INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INTERNATIONAL NORMALISED RATIO INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHROCAPS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524820-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>100MG  TID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIVALPROEX SODIUM</medicinalproduct>
        <drugdosagetext>250MG  TID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524821-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.3597</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524823-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXTROAMPHETAMINE 10MG  MALLINKROFT</medicinalproduct>
        <drugdosagetext>10MG  BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524824-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12650123</companynumb>
    <primarysource>
      <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>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>450 MG Q3W IV 31JUL2003-09OCT2003 (ON-STUDY) 450 MG Q3W IV 20-NOV-2003-(OFF STUDY)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>350 MG Q3W IV 31JUL2003-09OCT2003 (ON STUDY) 350 MG Q3W IV 20-NOV-2003 (OFF STUDY)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON GAMMA</medicinalproduct>
        <drugdosagetext>THERAPY FROM 31-JUL-2003 TO 27-OCT-2003</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031027</drugenddate>
        <drugtreatmentduration>89</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19700101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524825-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040909</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-BRISTOL-MYERS SQUIBB COMPANY-12697959</companynumb>
    <primarysource>
      <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>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDREA</medicinalproduct>
        <drugdosagetext>1 MG ONCE DAILY  THEN 0.5 MG TWICE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOCYTHAEMIA</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524826-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>0.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE GLUCONATE</medicinalproduct>
        <drugdosagetext>SEVERAL MLS</drugdosagetext>
        <drugindication>ANTIBACTERIAL PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524827-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414005BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.1324</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECONGESTANT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-HISTAMINE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524828-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415146BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>289554</drugbatchnumb>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>440 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524829-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12788808</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>THERAPY FROM 05-JUL-2004 TO 19-NOV-2004 (CYC 6) CUM DOSE=540 MG</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ENDOMETRIAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>THERAPY FROM 05-JUL-2004 TO 19-NOV-2004 (CYC 6) CUM DOSE=1620 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOMETRIAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>THERAPY FROM 05-JUL-2004 TO 19-NOV-2004 (CYC 6) CUM DOSE=480 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOMETRIAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524830-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12786430</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>THERAPY INITIATED 13-SEP-04. 17 COURSES TO DATE, TOTAL DOSE ADMIN. THIS COURSE=6122MG.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>THERAPY INITIATED 13-SEP-04. 17 COURSES TO DATE, TOTAL DOSE ADMIN. THIS COURSE=1826MG.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>THERAPY INITIATED 13-SEP-04. 17 COURSES TO DATE, TOTAL DOSE ADMIN. THIS COURSE=665MG.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugdosagetext>13-SEP-04 (1ST DOSE). 17 COURSES TO DATE, TOTAL DOSE ADMIN. TO DATE 6300 GY. [EXTERNAL BEAM, 3D]</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEOCIN T</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELSYM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXATIVES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524831-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12779138</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>INITIAL TX DATE: 17-SEP-04. 1932MG IS TOTAL DOSE ADM THIS COURSE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>INITIAL TX DATE: 17-SEP-04. 136MG TOTAL DOSE ADM THIS COURSE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugdosagetext>INITIAL TX DATE: 17-SEP-04. 174 MG TOTAL DOSE ADM THIS COURSE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugdosagetext>TOTAL DOSE ADM THIS COURSE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524832-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415588BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORIGINAL ALKA-SELTZER TABLETS</medicinalproduct>
        <drugbatchnumb>A4FO</drugbatchnumb>
        <drugdosagetext>1300 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>289034E</drugbatchnumb>
        <drugdosagetext>81 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>289034E</drugbatchnumb>
        <drugdosagetext>81 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (PURITAN BRAND)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524833-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12777116</companynumb>
    <primarysource>
      <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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATATONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>0.5/DAY = DOSAGE FORM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELISOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERESTA</medicinalproduct>
        <drugdosagetext>0.5 TWICE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524834-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12785812</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524835-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-BRISTOL-MYERS SQUIBB COMPANY-12780466</companynumb>
    <primarysource>
      <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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524836-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12786349</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040728</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040804</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL-D3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524837-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415774BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524838-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12782777</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524839-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.5964</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1500 MG/M2 IV; 150 MG (Q 3 WEEKS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1500 MG/M2 IV; 150 MG (Q 3 WEEKS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1500 MG/M2 IV; 150 MG (Q 3 WEEKS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1500 MG/M2 IV; 150 MG (Q 3 WEEKS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIROLACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524840-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12790291</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIXY321</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524841-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-12755302</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>CYCLE 1: 03-AUG-2004</drugdosagetext>
        <drugindication>BRONCHIAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>CYCLE 1: 03-AUG-2004</drugdosagetext>
        <drugindication>BRONCHIAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
        <drugdosagetext>CYCLE 1: 03-AUG-2004</drugdosagetext>
        <drugindication>BRONCHIAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON</medicinalproduct>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>FOR GASTRIC PROTECTION</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC+CHOLESTYRAMINE</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL XINAFOATE</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524842-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12783056</companynumb>
    <primarysource>
      <qualification>1</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>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040406</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040330</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524843-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12779237</companynumb>
    <primarysource>
      <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>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>AUC6 OR AUC5EDTA</drugdosagetext>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>AUC6 OR AUC5EDTA</drugdosagetext>
        <drugindication>PERITONEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugindication>PERITONEAL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PERITONEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugdosagetext>2 DOSE FORM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524844-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12788691</companynumb>
    <primarysource>
      <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>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ CAPS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugadministrationroute>048</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>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CENTRAL NERVOUS SYSTEM LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDINAVIR SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIMAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISPHOSPHONATES</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524845-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>10CC PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524846-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-240845</companynumb>
    <primarysource>
      <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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>4.8 MG (SEVEN DOSES)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INTRA-ABDOMINAL HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEPIRUDIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>THROMBOCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524847-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210887</companynumb>
    <primarysource>
      <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>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>250 MG, Q2W</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524848-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524849-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210086</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>375 MG, Q2W, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYLCLINE (MINOCYCLINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR (SALMETEROL XINAFOATE, FLUTICASONE PROPIONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL (ALBUTEROL SULFATE, ALBUTEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIPEN (EPINEPHRINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524850-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46.7205</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>150 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>150 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524851-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.0906</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugdosagetext>62.5 MG PO TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERSTITIAL LUNG DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugdosagetext>62.5 MG PO TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KCL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OROMORPH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORINAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-THYROXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524854-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.8842</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE STOOLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>600 MG/M2 EVERY 2 WEEKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>600 MG/M2 EVERY 2 WEEKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>600 MG/M2 EVERY 2 WEEKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>600 MG/M2 EVERY 2 WEEKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>600 MG/M2 EVERY 2 WEEKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>600 MG/M2 EVERY 2 WEEKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugdosagetext>60 MG/M2 EVERY 2 WEEKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugdosagetext>60 MG/M2 EVERY 2 WEEKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugdosagetext>60 MG/M2 EVERY 2 WEEKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugdosagetext>60 MG/M2 EVERY 2 WEEKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugdosagetext>60 MG/M2 EVERY 2 WEEKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugdosagetext>60 MG/M2 EVERY 2 WEEKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524859-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SOLVAY-00304004259</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19484</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UFT</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 800 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990407</drugenddate>
        <drugtreatmentduration>329</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CREON</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 9 GRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC INSUFFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000601</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <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>19980514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990602</drugenddate>
        <drugtreatmentduration>385</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LONGES</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 20 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 20 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980514</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524860-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SOLVAY-00304004262</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20076</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 2.5 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CREON</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 9 GRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC INSUFFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000601</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LONGES</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 20 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 20 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALESION</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 20 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000222</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524861-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>3 TABS PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524864-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040820</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-SOLVAY-00304002880</companynumb>
    <primarysource>
      <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>AMBLYOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: UNK. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>KLINEFELTER'S SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524865-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19990924</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SOLVAY-00399001310</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3144</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>27.7</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICES OESOPHAGEAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CREON</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 3 G. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTIC FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 12 MILLILITRE(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTIC FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTERONON-R</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 4 GRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTIC FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYMERON K1</medicinalproduct>
        <drugdosagetext>DAILY DOSE: .6 GRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTIC FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 2 DOSAGE FORM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTIC FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 0.5 GRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTIC FIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950620</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524866-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040820</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-SOLVAY-00304002880</companynumb>
    <primarysource>
      <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>AMBLYOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: UNK. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>KLINEFELTER'S SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524868-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE 20 MG TORPHARM (APOTEX)</medicinalproduct>
        <drugbatchnumb>GM 7913</drugbatchnumb>
        <drugdosagetext>20 MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524870-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12767034</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>136</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524871-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020418</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-11832466</companynumb>
    <primarysource>
      <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>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STADOL</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STADOL</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524872-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12779898</companynumb>
    <primarysource>
      <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>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>TONSIL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLIZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524873-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12790408</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
        <drugdosagetext>ONE TIME DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020325</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524874-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12789426</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040608</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040608</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACYT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040615</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524876-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BRISTOL-MYERS SQUIBB COMPANY-12705299</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED: PLACEBO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524877-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004-1807</companynumb>
    <primarysource>
      <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>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NYDRAZID (ISONAZID)</medicinalproduct>
        <drugauthorizationnumb>8662</drugauthorizationnumb>
        <drugindication>DISSEMINATED TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIMACTANE</medicinalproduct>
        <drugindication>DISSEMINATED TUBERCULOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524879-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004-1805</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugauthorizationnumb>75903</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>SINGLE DOSE OF 10MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POST PROCEDURAL VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPIVACAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524882-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004-1806</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QRS COMPLEX PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugauthorizationnumb>70302</drugauthorizationnumb>
        <drugdosagetext>OVERDOSE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE MALEATE</medicinalproduct>
        <drugdosagetext>OVERDOSE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524885-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20030703364</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.33</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030226</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030225</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030225</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>003</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030225</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030225</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030225</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDROGEL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030225</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030225</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030225</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030225</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030225</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030225</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030225</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030225</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030225</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARDONATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030225</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524894-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004-1812</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugauthorizationnumb>70302</drugauthorizationnumb>
        <drugdosagetext>4 MG DAILY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE MALEATE</medicinalproduct>
        <drugdosagetext>100 MG DAILY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBULISED SALBUTAMOL AND IPRATROPIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524896-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004-1814</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugauthorizationnumb>74478</drugauthorizationnumb>
        <drugdosagetext>10 MG ON ALL OCCASIONS</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugindication>AGORAPHOBIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524899-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200418802US</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN</medicinalproduct>
        <drugdosagetext>DOSE: TOTAL DOSE FOR 2 CYCLES: 560 MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: TOTAL DOSE 174 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>DOSE: 483 MG GIVEN ON 22-OCT-04, 29-OCT-04, AND 05-NOV-04. TOTAL=1449MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524900-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413720JP</companynumb>
    <primarysource>
      <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>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524901-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421851GDDC</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPERPIGMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLODRONIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMONACIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524902-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200418381US</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>D4C108</drugbatchnumb>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524905-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004-1813</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugauthorizationnumb>74478</drugauthorizationnumb>
        <drugdosagetext>10MG (2 DOSE) IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugdosagetext>150MG O.M. + 75MG O.N</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524907-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M2004-1815</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugauthorizationnumb>74376</drugauthorizationnumb>
        <drugdosagetext>50MG TDS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPPERMINT OIL MENTHA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL AND CHLORTHALIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL-CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524908-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414046FR</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECOTIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRATE DE BETAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SMECTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524910-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-240864</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>39</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID CHU PENFILL</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524912-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000119</companynumb>
    <primarysource>
      <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>INFECTED CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P01050</drugbatchnumb>
        <drugdosagetext>30 UG QW IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524913-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHNY2004CA02170</companynumb>
    <primarysource>
      <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>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUCKLEY'S DM DECONGESTANT(NCH)(DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEP</medicinalproduct>
        <drugdosagetext>1 TSP, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOBLOC (METOPROLOL TARTRATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524915-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-240850</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN L</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524916-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000181</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524917-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>003658</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugauthorizationnumb>76356</drugauthorizationnumb>
        <drugdosagetext>40.00 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugauthorizationnumb>76356</drugauthorizationnumb>
        <drugdosagetext>40.00 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524919-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000107</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROSPINAL FLUID LEAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524920-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1002762</companynumb>
    <primarysource></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>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>37.5 MG QD AND 12.5 MG PRN AGITATION, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>37.5 MG QD AND 12.5 MG PRN AGITATION, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA AND LEVODOPA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524921-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000179</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</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>20001101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524922-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100772</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING THORACIC ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL/PSEUDOEPHEDRINE (PARACETAMOL, PSEUDOEPHEDRINE)</medicinalproduct>
        <drugdosagetext>2 TABLETS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASAL CONGESTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524923-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000182</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BURNING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE STINGING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</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>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; UW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524925-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE742702DEC04</companynumb>
    <primarysource>
      <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>NEPHRECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>5 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524926-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100581</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GANGRENE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEG AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR PERIPHERAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE (MENTHOL, METHYL SALICYLATE, EUCALYPTOL, THYMOL)</medicinalproduct>
        <drugdosagetext>ORAL TOPICAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524927-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-03-013541</companynumb>
    <primarysource>
      <qualification>5</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>CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524929-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000247</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL 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>20020401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524931-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100256</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROLAIDS (MAGNESIUM HYDROXIDE, CALCIUM CARBONATE)</medicinalproduct>
        <drugbatchnumb>59672V</drugbatchnumb>
        <drugdosagetext>1 TABLET 5-6 TIMES QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB (CELECOXIB)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL (GLUCOSE MONOHYDRATE, ISPAGHULA HUSK)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524934-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000253</companynumb>
    <primarysource></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>PATELLA 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>19981102</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>4524935-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000251</companynumb>
    <primarysource></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>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</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>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</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>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524937-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>20041200498</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>75243</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524938-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000264</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</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>19970501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524939-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>201278</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>131.5431</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</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>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICATION (NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524940-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-05-0757</companynumb>
    <primarysource>
      <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>COLON CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>74949</drugauthorizationnumb>
        <drugdosagetext>100-225 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524941-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004092144</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugauthorizationnumb>9866</drugauthorizationnumb>
        <drugdosagetext>RECTAL</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>PROCTITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524942-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097884</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>40 MG 1 D ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKGO BILOBA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D (CALCIUM PHOSPHATE, CALCIUM SODIUM LACTATE, ERG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B-KOMPLEX ^LECIVA^ (CALCIUM PANTOTHENATE, NICOTINAMIDE, PYRIDOXINE HYD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3 TRIGLYCERIDES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524943-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-10-1485</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.5338</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>74949</drugauthorizationnumb>
        <drugdosagetext>150 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524944-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098839</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524945-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004073851</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPHANE 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 SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524946-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004075170</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.6068</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS (ASCORBIC ACID, ERGOCALCIFEROL, FOLIC ACID, NICOTINAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524947-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004088893</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>40 MG (40 MG) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524948-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-DE-05980GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRIDOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
        <drugauthorizationnumb>19085</drugauthorizationnumb>
        <drugdosagetext>IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORAMORPH SR</medicinalproduct>
        <drugdosagetext>75 MG, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE (FUROPSEMIDE)</medicinalproduct>
        <drugdosagetext>IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE</medicinalproduct>
        <drugdosagetext>100 MG (EVERY 6 HOURS),</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYGEN (OXYGEN)</medicinalproduct>
        <drugdosagetext>IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524949-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040302</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL068278</companynumb>
    <primarysource>
      <qualification>1</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>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524950-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-PRA100578</companynumb>
    <primarysource>
      <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>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGFILGRASTIM</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524951-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-13038RO</companynumb>
    <primarysource>
      <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>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>8 ML (WRONG DOSE)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524952-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AL000802</companynumb>
    <primarysource></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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>74342</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COCAINE</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524953-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AL000583</companynumb>
    <primarysource></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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>74342</drugauthorizationnumb>
        <drugdosagetext>1 MG; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>80 MG; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>160 MG; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524954-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US096518</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</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>PULMONARY MALFORMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524955-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041023</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-US097121</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524956-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US102285</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>L003821</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041202</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLATE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524957-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE218819NOV04</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVATREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524958-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-UK101236</companynumb>
    <primarysource>
      <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 FEBRILE NEUTROPHILIC DERMATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PERIPHERAL BLOOD STEM CELL APHERESIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524959-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AL000915</companynumb>
    <primarysource></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>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugauthorizationnumb>74869</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARISOPRODOL</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524960-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE260406DEC04</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VENOUS OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524963-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AL001672</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUSSIN CF</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUSSIN CF</medicinalproduct>
        <drugindication>INFLUENZA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUSSIN CF</medicinalproduct>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524965-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US097519</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARVOVIRUS B19 SEROLOGY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040922</drugenddate>
        <drugtreatmentduration>547</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>4524966-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-AMGEN-UK101110</companynumb>
    <primarysource>
      <qualification>3</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>NEULASTA</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPRAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524967-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US101608</companynumb>
    <primarysource>
      <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>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524968-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
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    <companynumb>GXKR2004US00473</companynumb>
    <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>ADRENOCORTICAL INSUFFICIENCY ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>80399</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>LIVER DISORDER</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN (WARFARIN)</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4524971-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2004US00471</companynumb>
    <primarysource>
      <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>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS NEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>64076</drugauthorizationnumb>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524974-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-US101788</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524976-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE248401DEC04</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524977-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GRWYE208317NOV04</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS ESCHERICHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMEBUTINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524978-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NLWYE257403DEC04</companynumb>
    <primarysource>
      <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>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524979-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE251102DEC04</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524980-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NLWYE257303DEC04</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524981-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US101358</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CALCIFICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524983-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US101286</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>181.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524984-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ESWYE254202DEC04</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TEMPORAL ARTERITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
        <drugtreatmentduration>201</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OS-CAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELEGILINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA</medicinalproduct>
        <drugdosagetext>300/75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524985-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099397</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE (MENTHOL, METHYL SALICYLATE, EUCALYPTOL, THYMOL)</medicinalproduct>
        <drugdosagetext>ALMOST ONE BOTTLE ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524987-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>003687</companynumb>
    <primarysource>
      <qualification>4</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 FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER IN SITU</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524990-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>003682</companynumb>
    <primarysource>
      <qualification>4</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>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524991-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>003681</companynumb>
    <primarysource>
      <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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OGEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524994-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>003685</companynumb>
    <primarysource>
      <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>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>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524996-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004091118</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524997-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>003677</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19931213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19931213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19931213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4524999-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099657</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.1637</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER (ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525000-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1002316</companynumb>
    <primarysource></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>HUNTINGTON'S CHOREA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>100MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>100MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HUNTINGTON'S CHOREA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>100MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEMANTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE WITH VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA/DOCUSATE</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>BISACODYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENEFIBER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOTAXIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROSE 5% NORMAL SALINE SOLUTION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525003-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1003511</companynumb>
    <primarysource></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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>12.5MG HS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>12.5MG HS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HALLUCINATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>12.5MG HS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA AND LEVODOPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525006-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101243</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4525007-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DL2004309</companynumb>
    <primarysource>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RUPTURED ECTOPIC PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>04001011409</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041106</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041107</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>4525009-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101492</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525013-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103486</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINUTAB SINUS MAXIMUM STRENGTH WITHOUT DROWSINESS (PARACETAMOL, PSEUDO</medicinalproduct>
        <drugbatchnumb>163221</drugbatchnumb>
        <drugdosagetext>1 TABLET 1-2 TIMES A MONTH, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUS CONGESTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (POTASSIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525016-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>003696</companynumb>
    <primarysource>
      <qualification>4</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 FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4525019-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101548</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>40 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990120</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugbatchnumb>C300935</drugbatchnumb>
        <drugdosagetext>200 MG (200 MG 1 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER (ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4525020-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>003697</companynumb>
    <primarysource>
      <qualification>4</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>BREAST CANCER FEMALE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001001</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001001</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001001</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>4525021-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1690</companynumb>
    <primarysource>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>74949</drugauthorizationnumb>
        <drugdosagetext>100-550MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
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        <drugenddate>20041101</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
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        <drugdosagetext>100-550MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990901</drugstartdate>
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        <drugenddate>20041101</drugenddate>
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  <safetyreport>
    <safetyreportid>4525023-3</safetyreportid>
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    <patient>
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        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
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        <drugdosagetext>300 MG QHS ORAL</drugdosagetext>
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        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
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        <drugstartdate>20040908</drugstartdate>
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        <drugenddate>20040926</drugenddate>
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      <drug>
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        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
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      <drug>
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      <drug>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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    <safetyreportid>4525024-5</safetyreportid>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
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    <companynumb>2004084512</companynumb>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
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    </patient>
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    <safetyreportid>4525025-7</safetyreportid>
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    <sender>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugauthorizationnumb>76192</drugauthorizationnumb>
        <drugdosagetext>150 MCG Q WK SUBCUTANEOU</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>1200 MG QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525026-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15849</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUTISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALCOHOLIC PSYCHOSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONTOMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALCOHOLIC PSYCHOSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERENACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALCOHOLIC PSYCHOSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALCOHOLIC PSYCHOSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EURODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALCOHOLIC PSYCHOSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525027-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16094</companynumb>
    <primarysource>
      <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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTUBATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>3600 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPROMEL</medicinalproduct>
        <drugdosagetext>9000 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HIRNAMIN</medicinalproduct>
        <drugdosagetext>150 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERCINE</medicinalproduct>
        <drugdosagetext>140 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZALIN</medicinalproduct>
        <drugdosagetext>300 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525028-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004BR17224</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELMAC / HTF 919A</medicinalproduct>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
        <drugtreatmentduration>43200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLANTABEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERIDIAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROGOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525029-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099521</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DRAMAMINE</medicinalproduct>
        <drugdosagetext>4-5 TABLETS QD PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MOTION SICKNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON (IRON)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525030-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099632</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZARONTIN SYRUP</medicinalproduct>
        <drugauthorizationnumb>80258</drugauthorizationnumb>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525031-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004091922</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUDAFED 12 HOUR</medicinalproduct>
        <drugbatchnumb>09924VA</drugbatchnumb>
        <drugdosagetext>1-4 TABLETS QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUS CONGESTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM (RISEDRONATE SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525033-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-06735-01</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
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        <drugstartdate>20040801</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525034-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BOEHRINGER INGELHEIM PHARMMACEUTICALS, INC.-2004-BP-13187NB</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDICON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRUFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALMYLAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPENON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>4525035-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-BP-10283BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100.24</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>403268A,3C0214</drugbatchnumb>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>403268A,3C0214</drugbatchnumb>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>403268A,3C0214</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITALIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIQUID OXYGEN (WITH EXERTION)</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525036-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BOEHRINGER INGELHEIM PHARMMACEUTICALS, INC.-2004-BP-13097BP</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugindication>COMPLICATIONS OF TRANSPLANTED KIDNEY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO (BLIND)</medicinalproduct>
        <drugindication>COMPLICATIONS OF TRANSPLANTED KIDNEY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525037-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-BP-12184BP</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>40 MG/80 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLESTIPOL HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGULAR INSULIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE NASAL SPRAY</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>NASAL CONGESTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19790101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525038-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-BP-10393BP</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZMACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VERTIGO</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525039-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BOEHRINGER INGELHEIM PHARMMACEUTICALS, INC.-2004-BP-13193BR</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXIGENOTERAPIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525041-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102402</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51.7101</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLTERODINE TARTRATE</medicinalproduct>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>4 MG (4 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVASTIGMINE TARTRATE (RIVASTIGMINE TARTRATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525045-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099586</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.8122</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLTERODINE TARTRATE</medicinalproduct>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>4 MG (4 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525048-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0301USA01091</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL SKIN TAGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROCYSTIC BREAST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020515</drugenddate>
        <drugtreatmentduration>419</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SURFAK</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525050-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103902</companynumb>
    <primarysource>
      <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>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525053-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0412USA01117</companynumb>
    <primarysource>
      <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>SINUS ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041204</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525054-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0411CAN00172</companynumb>
    <primarysource>
      <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>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525055-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0301USA01113</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525056-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004234382US</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>27.2158</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>(200 MG 4-8 DAILY)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPHENAMINE (CHLORPHENAMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN (GUAIFENESIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSEUDOEPHEDRINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525059-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004076262</companynumb>
    <primarysource></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>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugindication>VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525061-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0205USA01984</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>131</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK LEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLAVICLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSION POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COR PULMONALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB IMMOBILISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTRICTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MONARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN ES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010228</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525062-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA01808</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>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOLOBID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020925</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOLOBID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525063-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020514</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0205USA01793</companynumb>
    <primarysource>
      <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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-CARDIAC CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULITIS CERVICAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525065-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099940</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN KAPSEAL</medicinalproduct>
        <drugauthorizationnumb>84349</drugauthorizationnumb>
        <drugdosagetext>500 MG (500 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19680101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>500 MG (500 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL (ETHANOL)</medicinalproduct>
        <drugdosagetext>ONE TO TWO DRINKS DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525067-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101771</companynumb>
    <primarysource>
      <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>SUDDEN CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>300 MG (300 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525069-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004075214</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.3284</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL FLUCTUATING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>8762</drugauthorizationnumb>
        <drugdosagetext>300 MG (100 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM (MONTELUKAST SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525072-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004IL16566</companynumb>
    <primarysource>
      <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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525073-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004JP17522</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLAST CRISIS IN MYELOGENOUS LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040314</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525074-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004ES16369</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASPIRATION PLEURAL CAVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EWING'S SARCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STI</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EWING'S SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525076-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00846</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICHOMONIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEREX FORTE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN EXPECTORANT W/ CODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040529</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525077-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004095844</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525079-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098648</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.3993</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (POTASSIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN (VALSARTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAXALONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525081-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103347</companynumb>
    <primarysource>
      <qualification>1</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>21341</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525083-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102544</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525086-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0412USA01008</companynumb>
    <primarysource>
      <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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC HAEMORRHAGE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBROXOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE-S</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENATETRENONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOCYSTEINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525088-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104151</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525090-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102104</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM RECURRENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugdosagetext>4 MG (2 MG, 1 IN 2 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARISOPRODOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525093-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_25454_2004</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugauthorizationnumb>18602</drugauthorizationnumb>
        <drugdosagetext>DF</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525095-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0301USA02079</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED ACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC VARICES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE ROOT COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOULDER DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DECOMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525097-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096748</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG (1 IN 1 D)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525101-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>203408</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525102-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0307FRA00005</companynumb>
    <primarysource>
      <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>ALVEOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTRICTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORETHINDRONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525104-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00791</companynumb>
    <primarysource>
      <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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE HEART DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELTASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCANBID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525106-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>206795</companynumb>
    <primarysource></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>30 UG;QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011018</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>4525107-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00814</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTINIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER TRABECULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCAPNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </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>4525108-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00655</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGLE CLOSURE GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARTILAGE HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525110-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00841</companynumb>
    <primarysource>
      <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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS FIBROSING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLLAGEN-VASCULAR DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATOMYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL MOTILITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525115-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>171486</companynumb>
    <primarysource>
      <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>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P01020</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525119-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>206825</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525123-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415859BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugbatchnumb>282554A</drugbatchnumb>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>440 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525127-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415872BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REACTION TO DRUG EXCIPIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REACTION TO FOOD ADDITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDOL</medicinalproduct>
        <drugbatchnumb>287914D</drugbatchnumb>
        <drugdosagetext>1000/120/30 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSMENORRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525130-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00710</companynumb>
    <primarysource>
      <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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATOPHYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROGENIC BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDREA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEO-BI-FLEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525132-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415701BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.0187</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>260153A</drugbatchnumb>
        <drugdosagetext>325 MG , Q4HR, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525136-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415553BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugbatchnumb>281454A</drugbatchnumb>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext> SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugbatchnumb>281454A</drugbatchnumb>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext> SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEN-INDAPAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL /FRA/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENEDIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525138-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03948</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525140-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00883</companynumb>
    <primarysource>
      <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</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER INFECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER IN SITU</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL EYE NAEVUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOLYMPHATIC HYDROPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLANTAR FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEASONAL ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTEBROBASILAR INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL MSD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525144-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421117BWH</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROTININ</medicinalproduct>
        <drugauthorizationnumb>20304</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525146-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421116BWH</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROTININ</medicinalproduct>
        <drugauthorizationnumb>20304</drugauthorizationnumb>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525150-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA01227</companynumb>
    <primarysource>
      <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>ACTINIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TINEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIDERMAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA ANNULARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL BED BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525152-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE763706DEC04</companynumb>
    <primarysource></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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>3.375 G 1X PER 6 HR, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABDOMINAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugdosagetext>50 MG DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525156-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE718001DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>122.58</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEVERE ACUTE RESPIRATORY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT FLUCTUATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUG USED IN DIABETES (DRUG USED IN DIABETES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIAC THERAPY (CARDIAC THERAPY)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525159-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA00341</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
        <drugtreatmentduration>44</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DERMATOMYOSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525160-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0304USA00739</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA HAEMOLYTIC AUTOIMMUNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS EROSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROGENIC BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRACHEOBRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010501</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010501</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OS-CAL + D</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </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>REGLAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN-D</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SWELLING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SWELLING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESSALON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525163-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE876805MAR03</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIMETAPP</medicinalproduct>
        <drugauthorizationnumb>12436</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROBITUSSIN CF (GUAIFENESIN/DEXTROMETHORPHAN/PHENYLPROPANOLAMINE, SYRUP</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525168-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE259520JUL04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.33</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525171-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>235809K04USA</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525174-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00790</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>161</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVERSION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURED COCCYX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTOSE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MERALGIA PARAESTHETICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC PROTRUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FALL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVBID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATONINA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525181-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00631</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUTY ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRO-DUR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030522</drugenddate>
        <drugtreatmentduration>679</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LECITHIN AND PROTEIN (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030522</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</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>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM LA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPOTRIAD</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATIC FUNCTION ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STRESS SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525184-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00805</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>140</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA HAEMOPHILUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTMENOPAUSAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINEA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010418</drugenddate>
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        <drugadministrationroute>065</drugadministrationroute>
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        <drugstartdate>19990101</drugstartdate>
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      <drug>
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        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
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        <drugstartdate>20020101</drugstartdate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
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      <drug>
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        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
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        <drugstartdate>20030601</drugstartdate>
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        <drugadministrationroute>048</drugadministrationroute>
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        <drugstartdate>19990101</drugstartdate>
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        <medicinalproduct>PRILOSEC</medicinalproduct>
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        <medicinalproduct>EVISTA</medicinalproduct>
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        <medicinalproduct>ZOLOFT</medicinalproduct>
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        <medicinalproduct>LESCOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
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        <drugstartdate>19990722</drugstartdate>
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      <drug>
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        <medicinalproduct>COREG</medicinalproduct>
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    <receiver></receiver>
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      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
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        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
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        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
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        <drugenddate>20040101</drugenddate>
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      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
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        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
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        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040528</drugstartdate>
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    <safetyreportid>4525199-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
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    <sender>
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    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>KNEE OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
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      <drug>
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        <medicinalproduct>VIOXX</medicinalproduct>
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        <drugstartdateformat>102</drugstartdateformat>
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        <medicinalproduct>LIPITOR</medicinalproduct>
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        <medicinalproduct>AVANDIA</medicinalproduct>
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        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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    <safetyreportid>4525201-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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      <qualification>1</qualification>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
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        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
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        <medicinalproduct>ADVIL</medicinalproduct>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
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        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
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        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525204-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PH-MERCK-0412PHL00003</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525206-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03209</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HYDROCHLORIDE</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>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525208-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03954</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525209-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03202</companynumb>
    <primarysource>
      <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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525211-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0412AUS00002</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525214-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0412CAN00020</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525216-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-12786653</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040430</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525218-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12553376</companynumb>
    <primarysource>
      <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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>THERAPY DATES: 18-MAR-2004</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040318</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>THERAPY DATES: 18-MAR-2004</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040318</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON GAMMA</medicinalproduct>
        <drugdosagetext>THERAPY DATES: 18-MAR-2004</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040320</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLESTID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIBID DM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040309</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525219-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12784229</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPH NODE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugindication>RHABDOMYOSARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugindication>RHABDOMYOSARCOMA</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugindication>RHABDOMYOSARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugindication>RHABDOMYOSARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACTINOMYCIN</medicinalproduct>
        <drugindication>RHABDOMYOSARCOMA</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugindication>RHABDOMYOSARCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525221-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BRISTOL-MYERS SQUIBB COMPANY-12730503</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525222-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12780490</companynumb>
    <primarysource>
      <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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040506</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525224-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12760963</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRISTOPEN CAPS 500 MG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SKIN ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040918</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUNGIZONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SKIN ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040918</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAMMAZINE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040918</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SKIN ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040918</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SKIN ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040918</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LODALES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NERISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EOSIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525225-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12783783</companynumb>
    <primarysource>
      <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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525226-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031222</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-354748</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRANIAL NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOLYMPHATIC HYDROPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC STRESS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VESTIBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LARIAM</medicinalproduct>
        <drugdosagetext>23 TABLETS DISPENSED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUDAFED S.A.</medicinalproduct>
        <drugindication>RESPIRATORY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030415</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525227-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00080</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MASTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030217</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030217</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525229-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0412AUS00017</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525230-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00455</companynumb>
    <primarysource></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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525231-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00225</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIGAMENT INJURY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525232-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-MERCK-0412POL00002</companynumb>
    <primarysource>
      <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>ISCHAEMIC CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SPONDYLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525233-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00489</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525235-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PH-MERCK-0412PHL00004</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525236-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20041201139</companynumb>
    <primarysource>
      <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>FUNDOPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREPULSID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREPULSID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREPULSID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREPULSID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525237-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20041001058</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOSOCOMIAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREPULSID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETIC GASTROPARESIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525239-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00632</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525240-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19960426</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-62310</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOKET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIGASON</medicinalproduct>
        <drugdosagetext>PATIENT GIVEN 25MG DEC1982 - OCT1983, THEN GIVEN 35MG DEC1987-NOV 1988.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19821215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19881115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525241-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20011130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-302932</companynumb>
    <primarysource>
      <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>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS INFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COSTOCHONDRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOLLICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INGROWING NAIL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INGUINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENIS DEVIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PILONIDAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS ANI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOPOLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEBORRHOEIC DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEMINAL VESICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PAPILLOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPORTS INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINEA PEDIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19910515</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19921029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930401</drugenddate>
        <drugtreatmentduration>155</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19941015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19951116</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980827</drugenddate>
        <drugtreatmentduration>121</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugindication>SINOBRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBITUSSIN AC</medicinalproduct>
        <drugindication>SINUS CONGESTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRACYCLINE</medicinalproduct>
        <drugdosagetext>STOPPED WHILST ON AZITHROMYCIN.</drugdosagetext>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOLOG</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>1 CONCOMITANT DRUG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DHEA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIBID</medicinalproduct>
        <drugindication>SINOBRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIBID DM</medicinalproduct>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCOLATE</medicinalproduct>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTEX LA</medicinalproduct>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM A-D</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXICYCLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPRELAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAPROX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000523</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525244-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20011207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-303133</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GESTATIONAL DIABETES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020922</drugenddate>
        <drugtreatmentduration>336</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011203</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020929</drugenddate>
        <drugtreatmentduration>266</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525246-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01036</companynumb>
    <primarysource>
      <qualification>4</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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525247-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040909</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-380241</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SECRETION DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPERPIGMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DRAINAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040805</drugenddate>
        <drugtreatmentduration>129</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
        <drugtreatmentduration>119</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040805</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525249-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00720</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TEMPORAL ARTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGOLARYNGEAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525251-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00695</companynumb>
    <primarysource>
      <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>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525252-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00694</companynumb>
    <primarysource>
      <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>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK INJURY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525256-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>235822K04USA</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</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>20040811</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525258-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040924</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01111</companynumb>
    <primarysource>
      <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIPIDS INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525259-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00937</companynumb>
    <primarysource>
      <qualification>1</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>VYTORIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525261-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00633</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525262-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00635</companynumb>
    <primarysource>
      <qualification>4</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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525263-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00634</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525265-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01037</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525266-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00607</companynumb>
    <primarysource>
      <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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525267-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00545</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525269-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-388160</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBANDRONIC ACID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
        <drugtreatmentduration>312</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>GIVEN DAILY FOR FOUR FOLLOWING DAYS EVERY 14 DAYS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
        <drugtreatmentduration>312</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525270-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004092939</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525271-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-ROCHE-388099</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOPYON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRIDOCYCLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
        <drugtreatmentduration>291</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
        <drugtreatmentduration>291</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525272-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-388271</companynumb>
    <primarysource>
      <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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEMADEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EDECRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAROXOLYN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525274-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-388084</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</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>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525275-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041103943</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525276-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00608</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525277-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20041200493</companynumb>
    <primarysource>
      <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525278-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041002826</companynumb>
    <primarysource>
      <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>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>TINEA VERSICOLOUR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOGLIBOSE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525280-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-381266</companynumb>
    <primarysource>
      <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>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040728</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHINESE HERBAL MEDICINE</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS SYOUSAIKOTOU.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040710</drugenddate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHINESE HERBAL MEDICINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
        <drugtreatmentduration>198</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525281-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CIP04002438</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugauthorizationnumb>20835</drugauthorizationnumb>
        <drugdosagetext>35 MG ONCE WEEKLY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDREA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525282-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-381769</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040815</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525285-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-384701</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT LOSS POOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525287-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-ROCHE-383020</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</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>20040629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROPRAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NERISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AERIUS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525288-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-387238</companynumb>
    <primarysource>
      <qualification>1</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>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DALACIN</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONTOMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525289-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-385980</companynumb>
    <primarysource>
      <qualification>1</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>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDUCTION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugdosagetext>STRENGTH REPORTED AS 2.5ML.</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICE BCG</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040315</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZMACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525294-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-387274</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525295-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-385107</companynumb>
    <primarysource>
      <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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>ROUTE: LOCAL (SKIN, NAIL AND WOUND). FORM: EMULGEL</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUMIRELAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIALGIREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525297-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-388377</companynumb>
    <primarysource>
      <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>ALCOHOL POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525298-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-388482</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COD LIVER OIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525299-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000241</companynumb>
    <primarysource></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>AVONEX</medicinalproduct>
        <drugdosagetext>QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020913</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525300-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ROCHE-388439</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ILEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>ADMINISTERED ON DAYS 1-14 FOLLOWED BY 7 DAYS REST IN EACH CYCLE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITICAN</medicinalproduct>
        <drugdosagetext>PRN.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525303-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-388368</companynumb>
    <primarysource>
      <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>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040803</drugenddate>
        <drugtreatmentduration>130</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIAPRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040802</drugenddate>
        <drugtreatmentduration>129</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIAPRIDE</medicinalproduct>
        <drugdosagetext>RECHALLENGE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THERALENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040803</drugenddate>
        <drugtreatmentduration>130</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040804</drugenddate>
        <drugtreatmentduration>128</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LARGACTIL</medicinalproduct>
        <drugdosagetext>DISCONTINUED ON 03 AUGUST 2004, REINTRODUCED ON 13 AUGUST 2004.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040817</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525304-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-388504</companynumb>
    <primarysource>
      <qualification>1</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>XELODA</medicinalproduct>
        <drugdosagetext>FOR 3 DAYS FOLLOWED BY ONE WEEK REST</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040330</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040323</drugenddate>
        <drugtreatmentduration>127</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525305-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-MERCK-0412DNK00004</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUTANEOUS LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525307-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000245</companynumb>
    <primarysource></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>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525308-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200418855US</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAMPYLOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>CORONARY ANGIOPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCUVITE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525311-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>198404</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P30046</drugbatchnumb>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525316-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000545</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL EVOKED POTENTIALS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVINZA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525320-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414490FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAFORAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525321-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419213US</companynumb>
    <primarysource>
      <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>PUPILS UNEQUAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>INFLUENZA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525322-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419244US</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525323-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413580EU</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IATROGENIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN LISPRO</medicinalproduct>
        <drugbatchnumb>FF3Z36A</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOSMINA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENOUS INSUFFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040520</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525324-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414561FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EQUANIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525325-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419340US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525326-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419365US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>D083</drugbatchnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRO PATCH</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA                                   /USA/</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525327-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000577</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEELCHAIR USER</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>4525328-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200417620US</companynumb>
    <primarysource>
      <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>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041003</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525331-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>185927</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525333-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419101US</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO REACTION ON PREVIOUS EXPOSURE TO DRUG</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETRIUM</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUVELLE</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525338-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040825</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200416393US</companynumb>
    <primarysource>
      <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>BLOOD IRON DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>9467</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BLOOD DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PINDOLOL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLTX</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
        <drugindication>THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525339-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040806</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200412559JP</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOBAY</medicinalproduct>
        <drugdosagetext>DOSE: 3 TABLETS/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEZATOL</medicinalproduct>
        <drugdosagetext>DOSE: 2TABLETS/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANIRAPID</medicinalproduct>
        <drugdosagetext>DOSE: 1TABLET/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEROCRAL</medicinalproduct>
        <drugdosagetext>DOSE: 3TABLETS/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBELLAR INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE-A</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525341-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19951211</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-96121394</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEPHROBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19920219</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSMEGEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEPHROBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19920222</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSMEGEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19920401</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSMEGEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920522</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525342-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100270</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525343-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041202305</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525344-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041200206</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN INTRACRANIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525345-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041100017</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLIGHTED OVUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525346-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041007157</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525348-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-JNJFOC-20040906002</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION MISSED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugbatchnumb>03DB367</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040903</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525349-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004066266</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTRIGLYCERIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>06 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE (QUETIAPINE FUMRATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM (ESCITALOPRAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXCARBAZEPINE (OXCARBAZEPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES (ANTIHYPERTENSIVES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-DIOVAN (HYDROCHLOROTHIAZIDE, VALSARTARN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTAZEM HYDROCHLORIDE (DILTAZEM HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN (CLINDAMYCIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISRADIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL  HYDROCHLORIDE (QUINAPRIL HYDCROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE (ARIPIPRAZOLE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525350-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE03600</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIBACEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGIMERCK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOVER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCOL</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIXED HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525351-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00078</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525352-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-MERCK-0412SWE00012</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>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031219</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525353-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12786786</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugdosagetext>DOSAGE: DAILY; ^SOMETIMES UP TO 8 PILLS A DAY^</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525354-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20011109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0354954A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47.62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000601</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525358-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105547</companynumb>
    <primarysource>
      <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>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>200 MG (100 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525360-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102186</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525364-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004095675</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR CALCIFICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SILDENAFIL  (SILDENAFIL)</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525369-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004071674</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>50 MG, AS NECESSARY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525373-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103032</companynumb>
    <primarysource></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>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>21131</drugauthorizationnumb>
        <drugdosagetext>600 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525378-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104519</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525379-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020327</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0365440A</companynumb>
    <primarysource>
      <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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525380-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535567A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.6</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525381-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536385A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525382-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536577A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CANCER PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041206</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525383-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536602A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugbatchnumb>AD0702</drugbatchnumb>
        <drugdosagetext>2TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WATER PILL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525387-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536666A</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525388-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536676A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525389-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536770A</companynumb>
    <primarysource>
      <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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>150MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525390-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536830A</companynumb>
    <primarysource>
      <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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525391-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19910717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GLAXOSMITHKLINE-B0151603A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
        <drugdosagetext>4G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOXACILLIN SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900420</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525392-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19920128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-B0157001A</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
        <drugdosagetext>6G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525393-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0345846A</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLALIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
        <drugdosagetext>1CAP PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORMADINONE ACETATE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CAROTID ARTERY STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORNER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CAROTID ARTERY STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CAROTID ARTERY STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARNACULIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URALYT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROTROPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525394-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000543</companynumb>
    <primarysource></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>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</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>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</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>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PILL TO STOP SMOKING</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525398-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000541</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525399-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB03786</companynumb>
    <primarysource>
      <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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOPLASMA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REBOUND EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugdosagetext>1400MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABNORMAL BEHAVIOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
        <drugtreatmentduration>47</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525400-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0349717A</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOGORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525403-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000265</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525406-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GLAXOSMITHKLINE-B0350529A</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FURABID</medicinalproduct>
        <drugdosagetext>100MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICROGYNON 30</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525407-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0351246A</companynumb>
    <primarysource>
      <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugdosagetext>.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STOMACH DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525408-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0351247A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN 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>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugdosagetext>.5G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERENACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROXAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGIZONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA ASPERGILLUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSULFAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041009</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525409-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359017A</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MICROCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525410-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359019A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMIGRAN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525411-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359025A</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041128</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525412-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359026A</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARAPRIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TOXOPLASMOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFADIAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525413-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359041A</companynumb>
    <primarysource>
      <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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugdosagetext>150MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>204</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525414-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359042A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
        <drugtreatmentduration>87</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525415-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359043A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>33.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>8MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>1G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>250MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040614</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525416-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359044A</companynumb>
    <primarysource>
      <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>HOARSENESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BECOTIDE</medicinalproduct>
        <drugdosagetext>2PUFF TWICE PER DAY</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugdosagetext>5MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugdosagetext>2PUFF AS REQUIRED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525418-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359045A</companynumb>
    <primarysource>
      <qualification>5</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>LIP ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugdosagetext>500MCG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN</medicinalproduct>
        <drugdosagetext>400MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525419-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359046A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL REFLEX DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BECONASE</medicinalproduct>
        <drugbatchnumb>B85</drugbatchnumb>
        <drugdosagetext>50MCG SINGLE DOSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525420-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359048A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRE-EXISTING CONDITION IMPROVED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugdosagetext>10ML UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
        <drugtreatmentduration>83</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>10ML PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525421-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359049A</companynumb>
    <primarysource>
      <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>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugdosagetext>2UNIT TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTORETIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525422-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0359071A</companynumb>
    <primarysource>
      <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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTIDE DISKUS</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAXIZON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOKUNALIN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITH</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KIPRES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULTANOL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525423-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0359081A</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525424-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0359139A</companynumb>
    <primarysource>
      <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>DYSURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JOSIR</medicinalproduct>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TROSPIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525425-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0359188A</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>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>1G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMYCINE</medicinalproduct>
        <drugdosagetext>80MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENTEROCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OFLOCET</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENTEROCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODOPAR</medicinalproduct>
        <drugdosagetext>187.5MG EIGHT TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525426-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-GLAXOSMITHKLINE-B0359286A</companynumb>
    <primarysource>
      <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>AFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIANOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE DISKUS</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugdosagetext>75MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLVON</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPRAM</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNIFYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>70MG WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIMAGON-D3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>18MCG PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>2.5MG UNKNOWN</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLVON</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525427-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000260</companynumb>
    <primarysource></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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P30082</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525428-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F04200400200</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FONDAPARINUX SODIUM</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040506</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>75MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
        <drugdosagetext>175MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEMANTINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALEX</medicinalproduct>
        <drugdosagetext>40MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANEF</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALORON</medicinalproduct>
        <drugdosagetext>108MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIPLATELET THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>300MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAROTEN</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040506</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPASMO-URGENIN</medicinalproduct>
        <drugdosagetext>5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525429-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GLAXOSMITHKLINE-B0360093A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugdosagetext>1TAB THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACOVIL</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>4525430-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-GLAXOSMITHKLINE-B0360519A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFUROXIME AXETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISEDRONIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4525432-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041200666</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525433-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-JNJFOC-20040702353</companynumb>
    <primarysource>
      <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>BONE TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525434-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041103945</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERITONEAL TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25MG - 50MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4525435-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041102173</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDRONEL</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIXICAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPECIAFOLDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525438-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040817</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12673521</companynumb>
    <primarysource>
      <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>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTILATION/PERFUSION SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>AUC 5 OR AUC EDTA4 ON DAY 8</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HCL</medicinalproduct>
        <drugdosagetext>DAYS 1 AND 8</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525439-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000259</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.4514</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</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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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041127</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSOLINE</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>4525446-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000257</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>POLYMENORRHOEA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>THYROID DISORDER</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>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030501</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>20030501</drugstartdate>
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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>PROVIGIL (MODAFINAL)</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXPAPRO (ESCITALOPRAM OXALATE)</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
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  <safetyreport>
    <safetyreportid>4525449-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000254</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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      <reaction>
        <reactionmeddrapt>GALLBLADDER OPERATION</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>20040325</drugstartdate>
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  <safetyreport>
    <safetyreportid>4525452-8</safetyreportid>
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    <companynumb>2004BI000248</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
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        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
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        <drugstartdate>20020201</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugindication>MULTIPLE SCLEROSIS</drugindication>
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  <safetyreport>
    <safetyreportid>4525454-1</safetyreportid>
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      <qualification>3</qualification>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
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      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <reaction>
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        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020527</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>60 GY</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020605</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525456-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20041202707</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>50-100 MG TRANSPLACENTAL/TRANSMAMMRY DAILY</drugdosagetext>
        <drugindication>MATERNAL DRUGS AFFECTING FOETUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>TRANSPLACENTAL/TRANSMAMMARY</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URBANIL</medicinalproduct>
        <drugdosagetext>TRANSPLACENTAL/TRANSMAMMARY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525461-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHR-03-007598</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU/M2, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525469-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-028454</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020522</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525472-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24381</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>40 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>20 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525476-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24450</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525479-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW14422</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>5 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASERETIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525482-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>205920</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41.7309</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</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>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</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>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NALTREXONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525484-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>204484</companynumb>
    <primarysource>
      <qualification>5</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 TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHIFT TO THE LEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SECTRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525487-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>203476</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC MARGINAL ZONE LYMPHOMA</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>20030915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QVAR MDI</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525495-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0307GBR00186</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASOPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ANTRAL VASCULAR ECTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ANGIODYSPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL HAEMOGLOBIN CONCENTRATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL VOLUME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>20386</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030814</drugenddate>
        <drugtreatmentduration>113</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND CODEINE PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE/MG TRISILICATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DANTHRON/DOCUATE NA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIMETHICONE (+) HYDROTALCITE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUSS04</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525498-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0410USA02798</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>20386</drugauthorizationnumb>
        <drugdosagetext>25 MG/DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONEALFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM ASPARTATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525503-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0411USA03469</companynumb>
    <primarysource></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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRIDOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>20829</drugauthorizationnumb>
        <drugdosagetext>10 MG/DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030723</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>20829</drugauthorizationnumb>
        <drugdosagetext>10 MG/DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANDOLAPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525508-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0407USA02167</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>20829</drugauthorizationnumb>
        <drugdosagetext>10 MG/DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
        <drugtreatmentduration>319</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAINTATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIPHYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525512-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0402GBR00218</companynumb>
    <primarysource></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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugauthorizationnumb>21042</drugauthorizationnumb>
        <drugdosagetext>25 MG/DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040219</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525513-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0410GBR00029</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD UREA DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL HAEMOGLOBIN CONCENTRATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugauthorizationnumb>21042</drugauthorizationnumb>
        <drugdosagetext>25 MG/DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
        <drugtreatmentduration>103</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525518-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0404GBR00065</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BASOPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ELECTROLYTES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTED SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACROCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL VOLUME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>20386</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>20386</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>20386</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>20386</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>20386</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND CODEINE PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525520-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0411USA03492</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BILE DUCT CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>20386</drugauthorizationnumb>
        <drugdosagetext>25 MG/DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
        <drugtreatmentduration>1187</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525521-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0411GBR00082</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>20386</drugauthorizationnumb>
        <drugdosagetext>PO; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>20386</drugauthorizationnumb>
        <drugdosagetext>PO; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>20386</drugauthorizationnumb>
        <drugdosagetext>PO; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525524-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0411USA03908</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugauthorizationnumb>11664</drugauthorizationnumb>
        <drugdosagetext>2 MG/TID, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRAIN OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040306</drugenddate>
        <drugtreatmentduration>110</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INJ EDOTECARIN</medicinalproduct>
        <drugdosagetext>13 MG/M[2], PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040217</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525529-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0411USA03928</companynumb>
    <primarysource>
      <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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAB ETORICOXIB</medicinalproduct>
        <drugauthorizationnumb>21042</drugauthorizationnumb>
        <drugdosagetext>30 MG/DAILY/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>325 MG /PRN/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAB PLACEBO</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>15 MG/DAILY/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL ARTHRITIS EXTENDED RELIE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525535-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0406GBR00245</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOTAL CHOLESTEROL/HDL RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugauthorizationnumb>21042</drugauthorizationnumb>
        <drugdosagetext>25 MG/DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040527</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525541-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0406USA02667</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS EROSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugdosagetext>5 MG/DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040506</drugenddate>
        <drugtreatmentduration>246</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BAYASPIRIN (ASPIRIN)</medicinalproduct>
        <drugdosagetext>100 MG/DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040506</drugenddate>
        <drugtreatmentduration>1127</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANDEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERISLON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBILAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELTOUCH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALLIKREIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525543-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12784278</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525558-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCOMYST</medicinalproduct>
        <drugdosagetext>SOLUTION</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525562-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RACHEPINEPHRINE</medicinalproduct>
        <drugdosagetext>SOLUTION</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE</medicinalproduct>
        <drugdosagetext>SOLUTION</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525566-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENICILLIN G SODIUM</medicinalproduct>
        <drugdosagetext>INJECTABLE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAFCILLIN SODIUM</medicinalproduct>
        <drugdosagetext>INJECTABLE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525572-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN 0.2% OINTMENT</medicinalproduct>
        <drugdosagetext>TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525574-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCOMYST</medicinalproduct>
        <drugdosagetext>SOLUTION</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugdosagetext>TABLET</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525578-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
        <drugdosagetext>INJECTABLE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525589-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALAVERT</medicinalproduct>
        <drugdosagetext>TABLET</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525594-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugdosagetext>TABLET</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525597-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugdosagetext>INJECTABLE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFOTAN</medicinalproduct>
        <drugdosagetext>INJECTABLE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525600-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAFCIT</medicinalproduct>
        <drugdosagetext>SOLUTION</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAFCIT</medicinalproduct>
        <drugdosagetext>INJECTABLE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525603-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugdosagetext>TABLET</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIMADYL</medicinalproduct>
        <drugdosagetext>CAPSULE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525607-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
        <drugdosagetext>INHALANT</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525612-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101.6057</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>10MG  QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>10MG   BID    ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEMANTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525616-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugindication>SYSTEMIC ANTIVIRAL TREATMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXIVIR   700 MGM   BID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525621-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525624-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSPASM CORONARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL COLD AND SINUS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525627-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.246</patientweight>
      <patientsex>2</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 DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1000MG  Q24H INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugdosagetext>1000 MG Q24H INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525629-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugbatchnumb>DEA#BM7400372</drugbatchnumb>
        <drugdosagetext>1 A DAY</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525630-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERURICAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>235 MG DAY 1 INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525631-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.8435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugdosagetext>1 SHOT  EVERY 3 MONTHS  INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041210</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525633-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPERSONALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEREALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATIONS, MIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>100 MG TWICE DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>100 MG TWICE DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525634-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITALIA EXTERNAL PAINFUL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>300/150 MGM ONE Q 12 HOURS</drugdosagetext>
        <drugindication>ACCIDENTAL NEEDLE STICK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIXIVAN</medicinalproduct>
        <drugdosagetext>800 MGM  EVERY 8 HOURS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525636-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>117.9352</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGICAL PROCEDURE REPEATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>1 TAB DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040718</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525642-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040827</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2004ES00440</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE MB INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN E INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN I INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN TRIHYDRATE</medicinalproduct>
        <drugauthorizationnumb>64076</drugauthorizationnumb>
        <drugdosagetext>500 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACTERIAL INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525646-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2004GB00458</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPROLACTINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugauthorizationnumb>70302</drugauthorizationnumb>
        <drugdosagetext>10 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MOOD ALTERED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
        <drugdosagetext>175 - 75 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>37.5 MG, BIW, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYTETRACYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPICYCLINE (TETRACYCLINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525652-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2004GB00456</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugauthorizationnumb>18740</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>40 UNITS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN (LOSARTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN (METFORMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMOL (DEXTROPROPOXYPHENE HYDROCHLORIDE, PARACETAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525658-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100646</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORPHENIRAMINE/PARACETAMOL/PSEUDOEPHEDRINE (PARACETAMOL, PSEUDOEPHED</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525659-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1693</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>75972</drugauthorizationnumb>
        <drugdosagetext>500MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525765-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0282397-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
        <drugtreatmentduration>216</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030821</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525768-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-04P-087-0282681-00</companynumb>
    <primarysource></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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL ADMINISTRATION COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASOLAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTROPHIC CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19921108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASOLAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOSAPRIDE CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>P MAGEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIBENZOLINE SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTROPHIC CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525769-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0282473-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>31.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525770-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0282423-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CLONIC CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CLONIC CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525772-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0281597-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN ETHYLSUCCINATE ORAL SUSPENSION</medicinalproduct>
        <drugbatchnumb>08344VA</drugbatchnumb>
        <drugdosagetext>250MG/5ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525773-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0282472-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOXITIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525774-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0280784-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTIPHOSPHOLIPID ANTIBODIES POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <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>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</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>UNSPECIFIED MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525776-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0282639-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYTETRACYCLINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPATROPIUM BROMIDE</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525778-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0282288-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>121</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</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>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRMATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE EDISYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</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>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PILOCARPINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRY MOUTH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525779-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0282399-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.542</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040709</drugenddate>
        <drugtreatmentduration>524</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525781-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0264232-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040608</drugenddate>
        <drugtreatmentduration>343</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPRANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030608</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030608</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMAN MIXTARD</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040608</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040414</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525821-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0312USA00476</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE DELAYED UNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525823-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20010618</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-01061779</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525826-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00196</companynumb>
    <primarysource>
      <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>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525827-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0412FRA00025</companynumb>
    <primarysource>
      <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>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUINDIONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525828-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0411FRA00082</companynumb>
    <primarysource>
      <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>CEREBRAL ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALE PATTERN BALDNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525829-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00909</companynumb>
    <primarysource>
      <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>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525831-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-MERCK-0412DNK00009</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525832-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040826</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0408USA02143</companynumb>
    <primarysource>
      <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>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOTHIEPIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525840-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0205USA02119</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY RESTENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL HAEMORRHAGIC</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>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF LIBIDO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-CARDIAC CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525846-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0205USA02109</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>161</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANCER PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CLUSTER HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525847-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020411</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0204USA01392</companynumb>
    <primarysource>
      <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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525848-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20011024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-01104488</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC INDUCED ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPOTEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000901</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND CODEINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525850-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0205USA02097</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULATION TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC FOOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUTY ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYASTHENIA GRAVIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPEN ANGLE GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR GRAFT OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVASTATIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525853-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00741</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ATOPIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INNER EAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY GLAND CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
        <drugtreatmentduration>586</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELOCON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525855-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA04026</companynumb>
    <primarysource>
      <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>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010525</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUMARIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010525</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010525</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010613</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010613</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010613</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERISLON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010613</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010613</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUVOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525857-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00758</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>128</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOARSENESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORAZEPATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCERIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE AND TRIAMTERENE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPACET 100</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525860-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040408</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0404USA00963</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIXED HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020312</drugenddate>
        <drugtreatmentduration>611</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TREMOR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROSTAT</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525861-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0402USA00066</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTION TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011211</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525865-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030923</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0309USA02506</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BOWEL SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM DUODENAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HYPOMOTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTOSE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVEDO RETICULARIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALABSORPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CORTICAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINE ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010910</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010910</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19931101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19911101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELAFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEBETA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525866-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0407USA00560</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</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 CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020728</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525867-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00607</companynumb>
    <primarysource>
      <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>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525869-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00052</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>111</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CAUDA EQUINA SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZBROMARONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOLSIDOMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLDIGOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERBUTALINE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LERCANIDIPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL XINAFOATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XIPAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN HUMAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525870-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00103</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525871-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00308</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040922</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525877-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03726</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040106</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525879-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03808</companynumb>
    <primarysource>
      <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>RENAL ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[COMPOSITION UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525880-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA04030</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>INTENTIONAL MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525881-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA04079</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525882-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA02618</companynumb>
    <primarysource>
      <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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARAFON FORTE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525883-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03968</companynumb>
    <primarysource>
      <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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010325</drugenddate>
        <drugtreatmentduration>355</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525885-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15852</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CORTICOTROPHIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CORTISOL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARATHYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPONDYLITIC MYELOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525886-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE04093</companynumb>
    <primarysource>
      <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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugdosagetext>5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEMIPARESIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugdosagetext>2.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>900MG/DAY</drugdosagetext>
        <drugindication>HEMIPARESIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525888-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004PL16417</companynumb>
    <primarysource>
      <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>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>1500 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525889-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CH16569</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE INVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIGASTRIC DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYSEROSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPENTHIXOL</medicinalproduct>
        <drugdosagetext>5 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugindication>MANIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>1500 MG/D</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525890-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BR16449</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525892-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004IT16233</companynumb>
    <primarysource>
      <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>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAREG</medicinalproduct>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525893-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004RU16547</companynumb>
    <primarysource>
      <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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARLODEL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROLACTINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>87840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARLODEL</medicinalproduct>
        <drugdosagetext>0.625 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525895-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004PL16419</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>500 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525896-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004HK16428</companynumb>
    <primarysource>
      <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>ASEPTIC NECROSIS BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRRADIATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSULFAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525898-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004PL16418</companynumb>
    <primarysource>
      <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>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>1250 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525899-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004CZ17123</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIFE SUPPORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FTY720 VS MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>76320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525900-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004PL04136</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>1800 MG/D</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
        <drugtreatmentduration>14400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525902-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004US16262</companynumb>
    <primarysource>
      <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>CSF PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>360 MG/D</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MG/D</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugdosagetext>50 MG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugdosagetext>5 MG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>30 MG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZOSIN HCL</medicinalproduct>
        <drugdosagetext>9 MG/D</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525903-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04448</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525904-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004US16265</companynumb>
    <primarysource>
      <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>CSF PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MG/D</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugdosagetext>150 MG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>20 MG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525906-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004US16264</companynumb>
    <primarysource>
      <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>CSF PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>150 MG/D</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugdosagetext>50 MG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>30 MG EVERY OTHER DAY</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMAN GROWTH HORMONE, RECOMBINANT</medicinalproduct>
        <drugdosagetext>0.5 MG/KG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>100 MG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>500 MG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>120 MG/D</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525907-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00230</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525908-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0412AUS00031</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525910-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15632</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETAZIDINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>9 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
        <drugtreatmentduration>21600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525911-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12937</companynumb>
    <primarysource>
      <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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525913-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA02773</companynumb>
    <primarysource>
      <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 PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525914-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0412AUS00037</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[COMPOSITION UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[COMPOSITION UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525916-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00191</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC EFFECT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOZOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525917-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03820</companynumb>
    <primarysource>
      <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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DROOLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525919-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00858</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020213</drugenddate>
        <drugtreatmentduration>121</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525920-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00086</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525922-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA01968</companynumb>
    <primarysource>
      <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>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525924-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040617</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004CA08705</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXTROMETHORPHAN HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLURAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525925-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0412AUS00047</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525927-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-MERCK-0412DNK00006</companynumb>
    <primarysource>
      <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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525928-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-0412ESP00017</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525930-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03824</companynumb>
    <primarysource>
      <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525932-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00901</companynumb>
    <primarysource>
      <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>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
        <drugtreatmentduration>993</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525933-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00891</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525934-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00780</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525935-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0412FRA00029</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
        <drugtreatmentduration>432</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYDROGESTERONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE AND CHOLECALCIFEROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525936-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01088</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525937-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00949</companynumb>
    <primarysource>
      <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>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525938-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-MERCK-0412THA00002</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>13</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031110</drugenddate>
        <drugtreatmentduration>55</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPENEM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031030</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031007</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031009</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTYRAMINE RESIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031029</drugenddate>
        <drugtreatmentduration>44</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030919</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525939-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00723</companynumb>
    <primarysource>
      <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>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525940-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00713</companynumb>
    <primarysource>
      <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>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525951-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00926</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525952-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.5547</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>1 CAPSULE DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525953-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>1 TABLET DAY</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525954-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.7298</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>200 MG  ONE TIME INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525955-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>150MG   ONCE A DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>150MG   ONCE A DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>150MG   ONCE A DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041210</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525956-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525957-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AORTIC DISSECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLODRONATE   800 MG</medicinalproduct>
        <drugdosagetext>1600  QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525958-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>1 TABLET  AS NEEDED ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525959-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.5244</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>7.5 MG ONCE DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>7.5 MG ONCE DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS AND MINERALS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525961-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES  0410USA50152</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.8122</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY ATHEROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDIASTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugauthorizationnumb>21042</drugauthorizationnumb>
        <drugdosagetext>25 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525962-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES  0410USA50152</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL WEDGE PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugauthorizationnumb>21042</drugauthorizationnumb>
        <drugdosagetext>25 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525963-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.7913</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>ZOLOFT</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041210</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525964-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.1324</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>400MG  5X/D  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COMPLEX PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041209</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525965-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOZXAZOSIN   2 MGM</medicinalproduct>
        <drugdosagetext>1 DAILY</drugdosagetext>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOZXAZOSIN   2 MGM</medicinalproduct>
        <drugdosagetext>1 DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVOSTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525966-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41.7309</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
        <drugdosagetext>ONCE MONTH INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525967-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103.8737</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>50 MG  AT BEDTIME ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525968-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>100MG  BID  SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN  5 MG/TABLET  BARR</medicinalproduct>
        <drugdosagetext>5MG  QD  UD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525969-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>105.2345</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
        <drugdosagetext>3.75   ONCE A MONTH  INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
        <drugdosagetext>3.75   ONCE A MONTH  INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040228</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525970-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>17.2367</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL XR 25</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041205</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525971-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0358496A</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>96</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugauthorizationnumb>20405</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM GLUCEPTATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM SALT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525972-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0357406A</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTIOUS MONONUCLEOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO REACTION ON PREVIOUS EXPOSURE TO DRUG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MORBILLIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXIL</medicinalproduct>
        <drugauthorizationnumb>62216</drugauthorizationnumb>
        <drugindication>PHARYNGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CROMOGLYCATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525973-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0358575A</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>20207</drugauthorizationnumb>
        <drugdosagetext>50 MG/M2/ PER DAY/ INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIOTEPA</medicinalproduct>
        <drugdosagetext>250 MG/M2/ PER DAY/ INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>PER DAY/ INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEM CELL TRANSPLANT INFUSION (STEM CELL TRANSPLANT)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525974-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0358577A</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN INFUSION (MELPHALAN)</medicinalproduct>
        <drugauthorizationnumb>20207</drugauthorizationnumb>
        <drugdosagetext>50 MG/M2/ PER DAY/ INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIOTEPA</medicinalproduct>
        <drugdosagetext>250 MG/M2/ PER DAY/ INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>PER DAY/ INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEM CELL TRANSPLANT (STEM CELL TRANSPLANT)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525975-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0358578A</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>20207</drugauthorizationnumb>
        <drugdosagetext>50 MG/M2/ PER DAY/ INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIOTEPA</medicinalproduct>
        <drugdosagetext>250 MG/M2/ PER DAY/ INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>PER DAY/ INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEM CELL TRANSPLANT (STEM CELL TRANSPLANT)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525977-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0358579A</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>20207</drugauthorizationnumb>
        <drugdosagetext>50 MG/M2/ PER DAY/ INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIOTEPA</medicinalproduct>
        <drugdosagetext>250 MG/M2/ PER DAY/ INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>PER DAY/ INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEM CELL TRANSPLANT (STEM CELL TRANSPLANT)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525978-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041101851</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR PSEUDOANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; ABCIXIMA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETEPLASE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEBUTOLOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525979-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041200686</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKYLOSING SPONDYLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525980-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041200805</companynumb>
    <primarysource>
      <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>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVING THERPY FOR ONE YEAR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525981-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041201037</companynumb>
    <primarysource>
      <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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFUSE ALVEOLAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>2 DOSES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525982-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20041201171</companynumb>
    <primarysource>
      <qualification>3</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>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COR PULMONALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugdosagetext>4TH DOSE</drugdosagetext>
        <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>2</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525983-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-JNJFOC-20041201173</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>8 INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETHAMETASONE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETORICOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525984-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20040909277</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL 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>
      </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>049</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525985-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105878</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.46</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>8 INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>5MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525986-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041006297</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</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>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525987-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>APCDSS2002001059</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPPORTUNISTIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020903</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020304</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTECADIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTECADIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPERAZON</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020910</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPERAZON</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020910</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METILON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRAL INTRAVENOUS NUTRITION MAINTENANCE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525988-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040900431</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA VIRAL</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>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>7 TABLETS WEEKLY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>7 TABLETS WEEKLY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>750 MG, 4 TO 5 TABLETS DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525989-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20040909274</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CANDIDA 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>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>START DATE ^APPROXIMATELY 2002^</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525990-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041001020</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <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>
      </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>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEDACORT</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525991-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040810109</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>124.74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMYOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIFEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIFEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBERCON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS</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>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525992-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105907</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SJOGREN'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525993-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-0256</companynumb>
    <primarysource>
      <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>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugdosagetext>(4-8 MG QD)</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>DETOXIFICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4525995-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0358580A</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>20207</drugauthorizationnumb>
        <drugdosagetext>50 MG/M2/ PER DAY/ INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIOTEPA</medicinalproduct>
        <drugdosagetext>250 MG/M2/ PER DAY/ INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>PER DAY/ INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEM CELL TRANSPLANT (STEM CELL TRANSPLANT)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526001-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-122693-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>DF VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040323</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526004-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.0593</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>150MG   DAILY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>150MG   DAILY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABITRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526005-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.4003</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DESQUAMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>20MG  EVERY DAY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041211</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526008-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugbatchnumb>4HO81016</drugbatchnumb>
        <drugdosagetext>1 TO 2 TABS  EVERY 12 HOURS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526010-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.6892</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE   .075 MG    MOVA</medicinalproduct>
        <drugdosagetext>,075 MG   QD  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526011-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugdosagetext>ONE  DAILY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSIMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMHRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526014-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
        <drugdosagetext>2GRAM   Q24H   INTRAVENOU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526016-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>ASTHENIA</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>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>2   DAY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526017-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugdosagetext>1800MG/M2  1HR, DAYS 1-5   INTRAVENOU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>EWING'S SARCOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>100 MG/M2   1HR, DAYS 1-5    INTRAVENOU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526021-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210766</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>5 MG/KG, Q2W INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (POTASSIUM NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL (OXYCODONE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526027-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210763</companynumb>
    <primarysource>
      <qualification>2</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>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526029-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410655</companynumb>
    <primarysource>
      <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>BOTULISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX PURIFIED NEUROTOXIN COMPLEX</medicinalproduct>
        <drugindication>SKIN WRINKLING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526031-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410654</companynumb>
    <primarysource>
      <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>BOTULISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugindication>SKIN WRINKLING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526033-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410652</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BOTULISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMYOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS FLACCID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugindication>SKIN WRINKLING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526036-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410657</companynumb>
    <primarysource>
      <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>BOTULISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROMUSCULAR BLOCKADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugindication>SKIN WRINKLING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526039-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-029882</companynumb>
    <primarysource>
      <qualification>5</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>OESOPHAGEAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001201</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526042-3</safetyreportid>
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    <transmissiondate>20050328</transmissiondate>
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    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-031875</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47.6</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526047-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.7913</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>50MG  PER DAY</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>50MG  PER DAY</drugdosagetext>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526049-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>75 MG  ONCE DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>75 MG  ONCE DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526052-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.173</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>500MG  QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHOLANGITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526055-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>25  DAILY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>25  DAILY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041212</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526057-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE  200 MG  UDL</medicinalproduct>
        <drugdosagetext>800 MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>2.5 MG  DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </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>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526059-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25MG  DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENIERE'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031231</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25MG  DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TINNITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031231</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25MG  DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VERTIGO</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031231</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526066-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>225 MG TO 150 MG TO 112 MG TO 75 MG TO 37.5 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526068-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.4003</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>1 TABLET DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041209</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526070-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413568JP</companynumb>
    <primarysource>
      <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>ENTEROCOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>THYMOMA MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRIPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>THYMOMA MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526072-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0407USA00060</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.7507</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>11664</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>11664</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INJ EDOTECARIN</medicinalproduct>
        <drugdosagetext>23.1 MG/Q3W/IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE (+) TRIMETHOPRI</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526073-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50.5</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>04B154A</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>04B154A</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040609</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526075-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>44.4525</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>10 MG PO Q DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526078-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCOAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>7.5 MG PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526095-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526097-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526098-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CH16235</companynumb>
    <primarysource>
      <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>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIANOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>20 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugdosagetext>20 MG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugdosagetext>20 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>20 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIMAGON-D3</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>18 UG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>30 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORTIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLVON</medicinalproduct>
        <drugdosagetext>30 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPRAM</medicinalproduct>
        <drugdosagetext>20 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1825</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugdosagetext>20 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE DISKUS</medicinalproduct>
        <drugdosagetext>1 MG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNIFYL</medicinalproduct>
        <drugdosagetext>600 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526100-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.3597</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC DRIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526102-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.9978</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526106-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.1626</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugdosagetext>300MGM PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>3TC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526115-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.3388</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugdosagetext>150MG   DAILY  BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526116-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPERGILLOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN/HYDROCODONE 5/500MG</medicinalproduct>
        <drugdosagetext>1-2 TABS PO Q4HR PRN; MAX 8 IN 24 HR PERIOD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526117-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12758876</companynumb>
    <primarysource>
      <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>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugbatchnumb>03C00465/03C00519</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040629</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040629</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040629</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526118-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12787297</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugindication>COLON CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526119-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LS-BRISTOL-MYERS SQUIBB COMPANY-12781571</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugdosagetext>3RD COURSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugdosagetext>3RD COURSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>3RD COURSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
        <drugtreatmentduration>67</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526120-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugbatchnumb>4C0831G2</drugbatchnumb>
        <drugdosagetext>600MG  TWICE DAY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugbatchnumb>4C0831G2</drugbatchnumb>
        <drugdosagetext>600MG  TWICE DAY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUCOUS MEMBRANE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugbatchnumb>4E0856F</drugbatchnumb>
        <drugdosagetext>600MG  TWICE DAY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugbatchnumb>4E0856F</drugbatchnumb>
        <drugdosagetext>600MG  TWICE DAY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUCOUS MEMBRANE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526121-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12787628</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526122-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugdosagetext>1800MG/M2   1HR,DAYS 1-5   INTRAVENOU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>EWING'S SARCOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>100 MG/M2   1HR, DAYS1-5    INTRAVENOU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526123-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.1637</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugdosagetext>25 MG   DAY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526124-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.46</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSULFAN</medicinalproduct>
        <drugdosagetext>58MG  Q 6HRS   INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugdosagetext>1812 MG   Q 6HRS   INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTEPLASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASPOFUNGIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN ISOPHANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGULAR INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MISCELLANEOUS MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYTONADIONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN-TAZOBACTAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESPONSE TO MEDICATION FORM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALT + SODA MOUTHWASH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SCOPOLAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM POLYSTYRENE SULFONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526125-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526126-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYTUSSIN AC COUGH SYRUP (SUGAR FREE), MGP PRODUCT CODE 8045</medicinalproduct>
        <drugbatchnumb>26397A</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526129-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORICIDIN D SRT</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKA-SELTZER PLUS EFFERVESCENT TABLETS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXATRIM SUSTAINED RELEASE CAPSULES</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONE REPLACEMENT THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526131-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>CORICIDIN D (CHLORPHENIRAMINE/PHENYLPROPANOLAMINE/AS  TABLETS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526134-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.5338</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGRAPHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORICIDIN D SRT</medicinalproduct>
        <drugbatchnumb>6-AJB-1000</drugbatchnumb>
        <drugdosagetext>2 TABS/2 DOSE ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19971231</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526135-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORICIDIN D SRT</medicinalproduct>
        <drugdosagetext>2 PILLS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTIVE (NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526137-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.7403</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORICIDIN D SRT</medicinalproduct>
        <drugdosagetext>2 TABS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19620101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORICIDIN D SRT</medicinalproduct>
        <drugdosagetext>2 TABS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19620101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526140-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VESTIBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORICIDIN D SRT</medicinalproduct>
        <drugdosagetext>2-3 PILLS QD</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970322</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFRIN</medicinalproduct>
        <drugdosagetext>NAS AER SPRAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIFED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526145-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>7470</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEPTOCAINE</medicinalproduct>
        <drugauthorizationnumb>20971</drugauthorizationnumb>
        <drugdosagetext>1 CARPULE INJECTED</drugdosagetext>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPINEPHRINE 1:100,000</medicinalproduct>
        <drugindication>NERVE BLOCK</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526149-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PERC20040067</companynumb>
    <primarysource>
      <qualification>2</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugauthorizationnumb>40330</drugauthorizationnumb>
        <drugdosagetext>25 TABS ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526151-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PERC20040068</companynumb>
    <primarysource>
      <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>ANOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPIL FIXED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugauthorizationnumb>40330</drugauthorizationnumb>
        <drugdosagetext>80 TABS  ONCE  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526155-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PERC20040070</companynumb>
    <primarysource>
      <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>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET    UNKNOWN    UNKNOWN</medicinalproduct>
        <drugauthorizationnumb>40330</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526157-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PERC20040069</companynumb>
    <primarysource>
      <qualification>2</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>ANOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugauthorizationnumb>40330</drugauthorizationnumb>
        <drugdosagetext>60 TABS  ONCE  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526158-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-00858</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUILLAIN-BARRE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>5.00 MG, IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT (ERYTHROPOIETIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526159-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04090290</companynumb>
    <primarysource>
      <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>PREGNANCY OF PARTNER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSMISSION OF DRUG VIA SEMEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526160-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04100840</companynumb>
    <primarysource>
      <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>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>50 MG, QHS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040912</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526161-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DROOLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASKED FACIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>10 MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GUAIFENESIN/DEXTROMETHORPHAN</medicinalproduct>
        <drugdosagetext>600MG/30MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040209</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526162-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE721701DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATOMYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>100 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENTRICULAR TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040430</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KAVEPENIN (PHENOXYMETHYLPENICILLIN POTASSIUM,  )</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040418</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526163-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.9874</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>ONCE-TWICE Q6 HR PRN PAIN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526165-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SEWYE262407DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526166-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43.3185</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN-SR</medicinalproduct>
        <drugdosagetext>20 MG   2 TAB PO QAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526167-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE913019JUL04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AEROMONA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALOSPORINS AND RELATED SUBSTANCES (CEPHALOSPORNS AND RELATED SUBST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526169-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-CN-00438CN</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugauthorizationnumb>19085</drugauthorizationnumb>
        <drugdosagetext>20 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526170-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>133.8111</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN (HUMAN)</medicinalproduct>
        <drugdosagetext>14GM IV INFUSED OVER 6 HRS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POLYNEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN W/ MINERALS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526171-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-09778AU</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugdosagetext>18 MCG (18 MCG, 1 DAILY)</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL (PERINDOPRIL) (TA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526172-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>20.8655</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REFACTO  RZ KIT</medicinalproduct>
        <drugbatchnumb>20918ASIA</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REFACTO</medicinalproduct>
        <drugbatchnumb>20434ASIA</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526173-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>17.2367</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS C POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD</medicinalproduct>
        <drugbatchnumb>0313OAX11</drugbatchnumb>
        <drugdosagetext>15 GRAMS   IV   INTRAVENOU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>IMMUNODEFICIENCY COMMON VARIABLE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD</medicinalproduct>
        <drugbatchnumb>LE08C004AA</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD</medicinalproduct>
        <drugbatchnumb>LE08C009AA</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD</medicinalproduct>
        <drugbatchnumb>LE08CO18AA</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD</medicinalproduct>
        <drugbatchnumb>LE08D006AA</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD</medicinalproduct>
        <drugbatchnumb>LE08D018AA</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD</medicinalproduct>
        <drugbatchnumb>LE08D020AA</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD</medicinalproduct>
        <drugbatchnumb>LE08D021AB</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD</medicinalproduct>
        <drugbatchnumb>LE08D031AA</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD</medicinalproduct>
        <drugbatchnumb>LE08D038AA</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD</medicinalproduct>
        <drugbatchnumb>LE08D043AA</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD</medicinalproduct>
        <drugbatchnumb>LE08D044AA</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD</medicinalproduct>
        <drugbatchnumb>LE08D051AA</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD</medicinalproduct>
        <drugbatchnumb>LE08D057AB</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD</medicinalproduct>
        <drugbatchnumb>LE08D059AA</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD</medicinalproduct>
        <drugbatchnumb>LE08D065AB</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD</medicinalproduct>
        <drugbatchnumb>LE08D067AA</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD</medicinalproduct>
        <drugbatchnumb>LE08D084AA</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526174-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CREPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IVIG   6 GRAM VIALS    ZLB</medicinalproduct>
        <drugdosagetext>32 GRAMS   ONCE    INTRAVENOU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>THROMBOCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IV FLUIDS</medicinalproduct>
        <drugdosagetext>75 ML/HR   INTRAVENOU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526175-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-CN-00437CN</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugdosagetext>80 MG (80 MG, OD)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040919</drugenddate>
        <drugtreatmentduration>105</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORINAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526176-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>105511ISR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>89519</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526177-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>105515ISR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>89519</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526178-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420571BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.4723</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTION INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526179-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-115381-NL</companynumb>
    <primarysource></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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031004</drugstartdate>
        <drugtreatmentduration>75</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARNOC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMFEBUTAMONE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526181-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-122995-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGICAL PROCEDURE REPEATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>45 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526183-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-120831-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTROPHIA MYOTONICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugauthorizationnumb>18776</drugauthorizationnumb>
        <drugdosagetext>8 MG ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031205</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031205</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031206</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugdosagetext>50 UG ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031205</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugindication>ANALGESIC EFFECT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031205</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031205</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>EPHEDRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526184-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04120092</companynumb>
    <primarysource></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>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>50 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526186-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A01200405971</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NALIDIXIC ACID</medicinalproduct>
        <drugauthorizationnumb>17430</drugauthorizationnumb>
        <drugdosagetext>250 MG QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526187-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_23034_2003</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALLERGY TO PLANTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugauthorizationnumb>18998</drugauthorizationnumb>
        <drugdosagetext>5 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19880101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CROMOLYN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINIPRESS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526188-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031219</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200311542JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <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>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFREE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>DOSE: 4MG/WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031104</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526189-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040507</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200411605JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN S</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AUTOIMMUNE THYROIDITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APLACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>DOSE: 4MG/WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040302</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526190-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414237FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OGAST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526192-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>25740</companynumb>
    <primarysource>
      <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>APPLICATION SITE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDARA</medicinalproduct>
        <drugauthorizationnumb>20723</drugauthorizationnumb>
        <drugdosagetext>1 SACHET, 3 TOTAL, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>CONDYLOMA ACUMINATUM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526193-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE04176</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMYOTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN G INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLANGIOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS ANTIGEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER PYLORI IDENTIFICATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS E ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGAMMAGLOBULINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENZEN</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugdosagetext>8 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENZEN</medicinalproduct>
        <drugdosagetext>16 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040206</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526195-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-07696-01</companynumb>
    <primarysource>
      <qualification>2</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>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugdosagetext>5 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>15 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>5 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526196-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE06361</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>39</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLEMENT FACTOR INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATOMYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUADRIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugdosagetext>4 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODEOXYCHOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>S.M. POWDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROVITAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526197-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040820</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200412369BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>5 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526198-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19970624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S97-US-00371-01</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.8644</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIA URINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COSTOVERTEBRAL ANGLE TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAPUBIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY SEDIMENT PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROBILIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MONUROL</medicinalproduct>
        <drugauthorizationnumb>50717</drugauthorizationnumb>
        <drugdosagetext>3 G ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROBID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORDETTE-21</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALESSE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526199-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-0095PO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PONSTEL</medicinalproduct>
        <drugauthorizationnumb>15034</drugauthorizationnumb>
        <drugdosagetext>250 MG, QD, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526200-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-0079 PO FOLLOW UP 1</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PONSTEL</medicinalproduct>
        <drugauthorizationnumb>15034</drugauthorizationnumb>
        <drugdosagetext>1000 MG/BID/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PONSTEL</medicinalproduct>
        <drugauthorizationnumb>15034</drugauthorizationnumb>
        <drugdosagetext>1000 MG/BID/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>100 MG/ BID/ PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>100 MG/ BID/ PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526201-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SO4-UKI-07885-01</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK SECOND DEGREE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526202-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>167-20785-04120176</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE - PHARMION (THALIDOMIDE) (100 MILLIGRAM, CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>720 MG, DAILY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526203-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414236FR</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCOMMODATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMAUROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGRAPHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>TONSILLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROFENID</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526204-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200422007GDDC</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULINS AND ANALOGUES</medicinalproduct>
        <drugbatchnumb>SO04T10</drugbatchnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN (INSULIN PUMP)</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526205-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414530FR</companynumb>
    <primarysource></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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MALARONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LODALES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROVEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YOHIMBINE ^HOUDE^</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INIPOMP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERMIXON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526206-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414568FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DERINOX</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILOMAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PNEUMOREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBROXOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526207-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421912GDDC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SALPINGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SALPINGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526208-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421985GDDC</companynumb>
    <primarysource>
      <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 INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526209-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413616EU</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCHAL RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRAIN ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526210-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414611FR</companynumb>
    <primarysource></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>BRAIN ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRAIN ABSCESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugindication>PNEUMONITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugindication>BRAIN ABSCESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526211-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-029419</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLIMARA</medicinalproduct>
        <drugauthorizationnumb>20375</drugauthorizationnumb>
        <drugdosagetext>0.045/.015 MG.D, CONT, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>40 MG/D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526212-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200413350BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526213-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>167-20785-04120147</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE - PHARMION (THALIDOMIDE) (50 MILLIGRAM, CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>375 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>175 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE (RISEDRONATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCEOS (LEKOVIT CA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE (BECLOMETHASONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB (CELECOXIB)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE (DOMPERIDONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIXTARD (INITARD)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526214-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-029419</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLIMARA</medicinalproduct>
        <drugauthorizationnumb>21258</drugauthorizationnumb>
        <drugdosagetext>0.045/.015 MG/D, CONT, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>40 MG/D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526215-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200413524BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXB95A1</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFIDIPINE ER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526216-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A044-002-005341</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE (BENDROFLUAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL (PERINDOPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526217-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>004-041206</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.3993</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>EXTREMITY NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IATROGENIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASEPT 4% CHLORHEXIDINE GLUCONATE</medicinalproduct>
        <drugauthorizationnumb>19125</drugauthorizationnumb>
        <drugdosagetext>TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PREOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526218-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200415553BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.1626</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526219-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200417562BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108.8633</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526220-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-CAN-06657-01</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.3993</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED CELL DISTRIBUTION WIDTH INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELLS URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
        <drugauthorizationnumb>20401</drugauthorizationnumb>
        <drugdosagetext>360 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
        <drugdosagetext>240 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526221-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102312</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48.0813</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE (METHOL, METHYL SALICYLATE, EUCALYPTOL, THYMOL)</medicinalproduct>
        <drugdosagetext>1/8 OF A CUP, BID, ORAL TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DENTAL DISORDER PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COOL MINT LISTERINE POCKETPAKS (MENTHOL, METHYL SALICYLATE, EUCALYPTOL</medicinalproduct>
        <drugbatchnumb>20982L</drugbatchnumb>
        <drugdosagetext>ONE STRIP, PRN, ORLA TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRY MOUTH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC AICD (ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526222-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040806</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200417571BWH</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PREGNANCY OF PARTNER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526223-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004DE15544</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>800 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>64800</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PKC412</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>64800</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526224-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100741</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.3075</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IATROGENIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUDAFED 12 HOUR</medicinalproduct>
        <drugbatchnumb>00184VA</drugbatchnumb>
        <drugdosagetext>2 TABLETS 2-3X A DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE (ENLAPRIL MALEATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE (ESOMEPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIMETICONE, ACTIVATED (SIMETCONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526225-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004CH14834</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
        <drugtreatmentduration>1188</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENITEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODURETIC 5-50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID HUMAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526226-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>K200401838</companynumb>
    <primarysource>
      <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>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA GENITAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>19901</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN (FLUINDIONE) TABLET, 20 MG</medicinalproduct>
        <drugdosagetext>20 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526227-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040806</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200417609BWH</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE DRUG EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526228-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101527</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84.369</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGLE CLOSURE GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUDAFED 12 HOUR</medicinalproduct>
        <drugbatchnumb>04652V</drugbatchnumb>
        <drugdosagetext>UNSPECIFIED, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526229-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200324678BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.8748</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATECTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATECTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUSE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526230-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05929</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</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>MEROPEN</medicinalproduct>
        <drugauthorizationnumb>50706</drugauthorizationnumb>
        <drugdosagetext>1 G DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>AGRANULOCYTOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SELOKEN</medicinalproduct>
        <drugdosagetext>60 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BASEDOW'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugdosagetext>30 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BASEDOW'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHIMAZOLE</medicinalproduct>
        <drugdosagetext>80 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BASEDOW'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526231-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100575</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.1428</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE ANTISEPTIC MOUTHWASH (MENTHOL, METHYL SALICYLATE, EUCALYPTOL</medicinalproduct>
        <drugbatchnumb>192N3C</drugbatchnumb>
        <drugdosagetext>1 MOUTHFUL QD 1-2 TIMES PER WEEK, ORAL TOPICAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DENTAL DISORDER PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN (VALSARTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526232-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP06087</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526233-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24749</companynumb>
    <primarysource>
      <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>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>20578</drugauthorizationnumb>
        <drugdosagetext>10.8 MG DAILY SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526234-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02882</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugauthorizationnumb>17970</drugauthorizationnumb>
        <drugdosagetext>20 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526235-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200410979BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENIS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONTANEOUS PENILE ERECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DELAYED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAROXOLYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526236-7</safetyreportid>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCARBAZINE</medicinalproduct>
        <drugdosagetext>PREV. THERAPY: JAN91-MAR92 MAR88-MAR89</drugdosagetext>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VDS</medicinalproduct>
        <drugdosagetext>PREV. THERAPY: MAR88-MAR89</drugdosagetext>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19910101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIMUSTINE HCL</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19910101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THP-ADRIAMYCIN</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19910101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOBUZOXANE</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970916</drugenddate>
        <drugtreatmentduration>469</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526243-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12784914</companynumb>
    <primarysource>
      <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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC MICROANGIOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugdosagetext>INTERRUPTED PREVIOUSLY FOR 2 MONTHS DUE TO PANCREATITIS, RESUMED</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAQUINAVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526244-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004US16268</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CSF PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>3 MG/D</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVONORGESTREL AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugindication>DYSMENORRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>240 MG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG/D</drugdosagetext>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526245-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040315</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004204274CH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXANTHEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPONIT (NITROGLYCERIN) PATCH</medicinalproduct>
        <drugauthorizationnumb>20146</drugauthorizationnumb>
        <drugdosagetext>1 PATCH, QD, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENITEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORBIDILAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOREM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526246-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12738464</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>LOADING DOSE (680 MG): TOOK 27 CC IVPB PRIOR TO EVENTS, STOPPED AFTER 10 MIN.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>GIVEN 1 HOUR BEFORE CETUXIMAB</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>GIVEN 1 HR BEFORE CETUXIMAB</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>GIVEN 1 HR BEFORE CETUXIMAB INFUSION</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>GIVEN 1 HR BEFORE CETUXIMAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526247-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-12771911</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526248-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040804</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-12661120</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>INITIAL TX DATE: 18-JUN-04. PT REC'D 7 DOSES AT THE TIME OF THE EVENT.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugdosagetext>PRE-2001.</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCAINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526249-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004FR15396</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER REMOVAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY ATHEROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMORAL ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUGULAR VEIN DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERIOR VENA CAVAL OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR BYPASS GRAFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VEIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESERNIL</medicinalproduct>
        <drugindication>FACIAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526250-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>MPS1-10291</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDURAZYME</medicinalproduct>
        <drugdosagetext>0.58 MG/KG QWK IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MUCOPOLYSACCHARIDOSIS I</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526251-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SP-2004-001954</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMETEC 10</medicinalproduct>
        <drugauthorizationnumb>21286</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526252-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0011</companynumb>
    <primarysource>
      <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>ENCEPHALITIS VIRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELESTONE</medicinalproduct>
        <drugauthorizationnumb>14215</drugauthorizationnumb>
        <drugdosagetext>0.5 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR, NOSE AND THROAT EXAMINATION ABNORMAL</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLIXONASE (FLUTICASONE PROPIONATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526253-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099825</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSPASM CORONARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXTROMETHORPHAN/PARACETAMOL/PSEUDOEPHEDRINNE (PARACETAMOL, PSEUDOEPHE</medicinalproduct>
        <drugdosagetext>4 TABS TWICE IN 3 HOURS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526254-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-240856</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENFILL N CHU</medicinalproduct>
        <drugdosagetext>4 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>6+4+4=14 IU/QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526255-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02398</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYTACAND</medicinalproduct>
        <drugauthorizationnumb>21093</drugauthorizationnumb>
        <drugdosagetext>1 DF DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>1 DF DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DI-ANTALVIC</medicinalproduct>
        <drugdosagetext>6 DF DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NON STEROID ANTIINFLAMMATORY DRUG</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TROXERUTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAMUDOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526256-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>23100208</companynumb>
    <primarysource>
      <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>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>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARGATROBAN</medicinalproduct>
        <drugauthorizationnumb>20883</drugauthorizationnumb>
        <drugdosagetext>60 MG DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARGATROBAN</medicinalproduct>
        <drugdosagetext>20 MG DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADICUT</medicinalproduct>
        <drugdosagetext>60 MG DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTCILLIN</medicinalproduct>
        <drugdosagetext>2 G DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCEOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526257-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05024</companynumb>
    <primarysource></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>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACECOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPOCA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526258-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>MPS1-10292</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDURAZYME</medicinalproduct>
        <drugdosagetext>0.58 MG/KG  QWK  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MUCOPOLYSACCHARIDOSIS I</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526259-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE06679</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>125 MG BID; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDREX SEMI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEKSAVIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINIFOM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526260-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>MPS1-10293</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDURAZYME</medicinalproduct>
        <drugdosagetext>0.58 MG/KG  QWK  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526261-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04P-056-0281274-00</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMERASE CHAIN REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>40 MG , SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526262-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2004AU01498</companynumb>
    <primarysource>
      <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>LICHEN SCLEROSUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
        <drugtreatmentduration>30240</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABEX</medicinalproduct>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526263-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05832</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>25 MG DAILY; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELIRIUM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHYTHMY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZELASTINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TALION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC ^GLAXO WELLCOME^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAC B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERDIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526264-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE06623</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTIBODY TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROPHORESIS PROTEIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEMPHIGOID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENZEN</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugdosagetext>4 MG QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENZEN</medicinalproduct>
        <drugdosagetext>8 MG QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FONLIPOL</medicinalproduct>
        <drugdosagetext>2 DP DAILY; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>1 DF QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOCOLPHA CAP</medicinalproduct>
        <drugdosagetext>500 MG QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDIATENSYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526265-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES  0411PHL00027</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INJ PRIMAXIN (IMIPENEM/CILASTATN SODIUM)</medicinalproduct>
        <drugauthorizationnumb>50587</drugauthorizationnumb>
        <drugdosagetext>500 MG/QH6 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABDOMINAL INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526266-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-10-1191</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>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>180 UG QW</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526267-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>MPS1-10294</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDURAZYME</medicinalproduct>
        <drugdosagetext>43.5 MG QWK  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031217</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526268-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2004AU01663</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.0151</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEMICAL BURN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEMICAL POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS CHEMICAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISUDYNE</medicinalproduct>
        <drugauthorizationnumb>21119</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELLARIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRAMIL</medicinalproduct>
        <drugdosagetext>20 MG DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE ACETONIDE</medicinalproduct>
        <drugdosagetext>6 MG DAILY EYE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526269-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040805</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>MPS1-10229</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>20</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDURAZYME</medicinalproduct>
        <drugdosagetext>11.6 MG QWK  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MUCOPOLYSACCHARIDOSIS I</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040318</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526270-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES  0411PHL00026</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>BILIARY ANASTOMOSIS COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugauthorizationnumb>50587</drugauthorizationnumb>
        <drugdosagetext>500 MG/Q6H IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABDOMINAL INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526271-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBR-2004-0001397</companynumb>
    <primarysource>
      <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>DELUSIONAL DISORDER, PERSECUTORY TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALLADONE</medicinalproduct>
        <drugauthorizationnumb>21044</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALLADONE</medicinalproduct>
        <drugauthorizationnumb>21044</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugdosagetext>20 MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASAFLOW</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL, (SODIUM BICARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZOLAN (TRAZODONE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526273-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>0400046EN0020P</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>27</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLOSSAL NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IIIRD NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCASPAR</medicinalproduct>
        <drugdosagetext>2500 IU/M2 Q14D</drugdosagetext>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugdosagetext>2 MG/M2 Q7D</drugdosagetext>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>6 MG/M2 DAYS 1 AND 15</drugdosagetext>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>1 MG/KG</drugdosagetext>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040803</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526275-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES  0411PHL00025</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugauthorizationnumb>50587</drugauthorizationnumb>
        <drugdosagetext>500 MG/Q6H IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABDOMINAL INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526276-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ST-2004-008157</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMETEC</medicinalproduct>
        <drugauthorizationnumb>21286</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526277-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19981125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SOLVAY-00302000385</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>839</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>42.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPEMIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 2 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19971214</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CREON</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 3 G. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19971208</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MITOMYCIN C</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 4 MG. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526278-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040422</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SOLVAY-00304001150</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIURIA</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>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE ADHESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOPEN</medicinalproduct>
        <drugdosagetext>DAILY DOSE: UNK. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CREON</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 3 G. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980429</drugenddate>
        <drugtreatmentduration>224</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CREON</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 3 G. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980916</drugenddate>
        <drugtreatmentduration>73</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAC B</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 9 GRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTESTINAL FUNCTIONAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970929</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 25 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHOLANGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19971014</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 24 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980109</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PL</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 9 GRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980108</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526279-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040315</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004204274CH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXANTHEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPONIT</medicinalproduct>
        <drugauthorizationnumb>20146</drugauthorizationnumb>
        <drugdosagetext>1 PATCH,QD,TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENTEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORBIDILAT - SLOW RELEASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOREM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526280-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040310</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004202204PT</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITRADISC(NITROGLYCERIN) PATCH</medicinalproduct>
        <drugauthorizationnumb>20146</drugauthorizationnumb>
        <drugdosagetext>TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526282-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13111</companynumb>
    <primarysource>
      <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526283-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040405</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>001261</companynumb>
    <primarysource>
      <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>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>40197</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526284-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SOLVAY-00204004325</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDUCTIVE DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 4 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040421</drugenddate>
        <drugtreatmentduration>203</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526285-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0411GBR00233</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.7403</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SILENT MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugauthorizationnumb>21042</drugauthorizationnumb>
        <drugdosagetext>25 MG/DAILY/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041002</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526286-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SOLVAY-00204004311</companynumb>
    <primarysource>
      <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>ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 2 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 4 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 6 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM AUROTHIOMALATE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 50 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526287-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D0045323A</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOVATE</medicinalproduct>
        <drugauthorizationnumb>19323</drugauthorizationnumb>
        <drugdosagetext>TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BASISCREME (FORMULATION UNKNOWN) (BASISCREME)</medicinalproduct>
        <drugdosagetext>TOPICAL   (DURATION: YEARS)</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRALAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPICAL SKIN PREPARATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526288-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040715</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>002039</companynumb>
    <primarysource>
      <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>ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>40197</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526289-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INDIFFERENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
        <drugbatchnumb>P4015</drugbatchnumb>
        <drugdosagetext>20 MG  ONCE DAIL   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTRIGLYCERIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526290-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-UK098182</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POIKILOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN INTRAVENOUS (HUMAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIFEDIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526291-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-US101138</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPARATHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE-ALPHA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526292-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040715</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>002045</companynumb>
    <primarysource>
      <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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>40197</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526293-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-UK100335</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</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>4526294-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>002179</companynumb>
    <primarysource>
      <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>ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>40197</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526295-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>002216</companynumb>
    <primarysource>
      <qualification>4</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>ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>40197</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROPIPATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AYGESTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETRIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIPATCH</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000802</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526296-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.5129</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>20 MG PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526297-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.978</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENERIC CHOLESTYRAMINE</medicinalproduct>
        <drugdosagetext>1 SCOOP PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BILIARY CIRRHOSIS PRIMARY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526299-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US096999</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENITAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALDECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526300-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004PL16420</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>400 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526301-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004PL16422</companynumb>
    <primarysource>
      <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>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>300 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526302-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US097100</companynumb>
    <primarysource>
      <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>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526303-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.6788</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN/CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526304-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004PL16423</companynumb>
    <primarysource>
      <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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>250 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526305-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US097172</companynumb>
    <primarysource></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>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526306-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TNZFR200400115</companynumb>
    <primarysource>
      <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 UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL VARICES HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INNOHEP</medicinalproduct>
        <drugauthorizationnumb>20484</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INNOHEP</medicinalproduct>
        <drugauthorizationnumb>20484</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN (FLUINDIONE) (TABLETS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526307-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US097325</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 1 IN 1 WEEKS, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526308-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-2004-035279</companynumb>
    <primarysource>
      <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>IUCD COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEIZURE ANOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>41118C</drugbatchnumb>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526309-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US097640</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526310-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>5 MG 2 DAILY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526311-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2004-032367</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040302</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526312-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US098381</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>13</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION (UNSPECIFIED NON-STEROIDAL ANTI-INFLAMMATORY AG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526313-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2004-035835</companynumb>
    <primarysource>
      <qualification>1</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>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526314-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004PL16424</companynumb>
    <primarysource>
      <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>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>250 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526315-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004PL16431</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526316-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004PL16430</companynumb>
    <primarysource>
      <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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>240 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526317-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004PL16433</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526318-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VISP-NO-0412S-0504</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISIPAQUE</medicinalproduct>
        <drugauthorizationnumb>20351</drugauthorizationnumb>
        <drugdosagetext>100 ML, SINGLE DOSE, I.A.</drugdosagetext>
        <drugindication>ARTERIAL BYPASS OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN( HEPARINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAMANDOLE NAFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFLOMEDIL HYDROCHLORIDE (FONZYLANE0</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526319-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOGRAFT BONE GRAFTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526320-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003-01-0208</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL RETARDATION SEVERITY UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSMISSION OF DRUG VIA SEMEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAFERONPEG</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMANTADINE OR PLACEBO (BLINDED STUDY DRUG)</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526321-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0020</companynumb>
    <primarysource>
      <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>GENITAL PRURITUS FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELESTONE</medicinalproduct>
        <drugauthorizationnumb>14215</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTIM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMALINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040815</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526322-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-06-1139</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526323-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.7507</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>40 MG DAILY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>40 MG DAILY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526324-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>TEGRETOL</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526325-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20 MG Q AM</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526326-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2004-032788</companynumb>
    <primarysource>
      <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>ABDOMINAL WALL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAFERON (INTEFERON BETA - 1B) INJECTION, 250UG</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPASMEX (TROSPIUM CHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526327-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02464</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC DRUG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526328-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004PK02045</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIANOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugauthorizationnumb>19777</drugauthorizationnumb>
        <drugdosagetext>20 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugdosagetext>150 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLVON</medicinalproduct>
        <drugdosagetext>30 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041010</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPRAM B</medicinalproduct>
        <drugdosagetext>20 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE DISKUS</medicinalproduct>
        <drugdosagetext>1000 UG DAILY IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNIFYL</medicinalproduct>
        <drugdosagetext>600 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIMAGON-D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526329-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.1626</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCARDIA XL</medicinalproduct>
        <drugdosagetext>BID</drugdosagetext>
        <drugindication>HYPOTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526330-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-2004-035888</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CERVIX CARCINOMA STAGE 0</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IUCD COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVONORGESTREL</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526331-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004242928DE</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>138</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID SOLUTION, STERILE (LINEZOLID)</medicinalproduct>
        <drugauthorizationnumb>21131</drugauthorizationnumb>
        <drugdosagetext>1200 MG (600 MG, BID), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIBIONTA (ASCORBIC ACID, CALCIUM PANTOTHENATE, CYANOCOBALAMIN, NICO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENIUM (SELENIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC DL-ASPARTATE (ZINC DL-ASPARTATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIMETICONE, ACTIVATED (SIMETICONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN-FRACTION, SODIUM SALT (HEPARIN-FRACTION, SODIUM SALT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRITRAMIDE (PIRITRAMIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526332-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-2004-035887</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ECTOPIC PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JASMINE (DROSPIRENONE,  ETHINYLESTRADIOL) FILM TABLET</medicinalproduct>
        <drugauthorizationnumb>21098</drugauthorizationnumb>
        <drugdosagetext>1 TAB(S), 21D/28D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526333-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-2004-035916</companynumb>
    <primarysource>
      <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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPHTHALMOPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>21098</drugauthorizationnumb>
        <drugdosagetext>1 TAB(S), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526334-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101087</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRAMUSTINE PHOSPHATE SODIUM CAPSULE (ESTRAMUSTINE PHOSPHATE SODIUM)</medicinalproduct>
        <drugauthorizationnumb>18045</drugauthorizationnumb>
        <drugdosagetext>(CYCLICAL)</drugdosagetext>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL (DOCETAXEL)</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIALLERGIC AGENTS EXCL CORTICOSTEROIDS (ANTIALLERGIC AGENTS, EXCL CO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526335-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2004-035478</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IUCD COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>INSERTION UNSUCCESSFUL</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526336-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103051</companynumb>
    <primarysource>
      <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>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY ALLERGIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUNBURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugdosagetext>1 DOSE FORM, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040903</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugdosagetext>1 DOSE FORM (INTERVAL:  EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040903</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TROLAMINE (TROLAMINE)</medicinalproduct>
        <drugdosagetext>TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>SUNBURN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugdosagetext>TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>SUNBURN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID (ACETYLSALICYLIC ACID)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040903</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPASMINE (CRATAEGUS SPP FLOWER POWDER, VALERIANA OFFICINALIS ROOT DRY </medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040903</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526337-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0031</companynumb>
    <primarysource>
      <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugauthorizationnumb>50039</drugauthorizationnumb>
        <drugindication>BACTERIAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526338-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099917</companynumb>
    <primarysource>
      <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>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>10392</drugauthorizationnumb>
        <drugdosagetext>(50 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROPIVACAINE (ROPIVACAINE)</medicinalproduct>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUFENTANIL CITRATE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugdosagetext>INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEFOPAM (NEFOPAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526339-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02892</companynumb>
    <primarysource></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>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040405</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526340-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-603</companynumb>
    <primarysource></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>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>12.5 TABLET 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADANCOR (NICORANDIL)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>120 MG 1X PER 1 DAY, ORA</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>80 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>10 MG 2X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526341-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004094064</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>(40 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526342-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-602</companynumb>
    <primarysource>
      <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>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA LEGIONELLA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>3 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG 2X PER 1 WK, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526343-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103730</companynumb>
    <primarysource>
      <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>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDURA XL</medicinalproduct>
        <drugauthorizationnumb>19668</drugauthorizationnumb>
        <drugdosagetext>4 MG (4 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES (ANTIHYPERTENSIVES)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526344-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004093607</companynumb>
    <primarysource>
      <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>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE SODIUM SUCCINATE</medicinalproduct>
        <drugauthorizationnumb>9866</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, ONCE), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>URTICARIA GENERALISED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYZINE HCL</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>URTICARIA GENERALISED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE 0.9%</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526345-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-610</companynumb>
    <primarysource>
      <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>BLADDER NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>10 MG 1X PER 1 WK,</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526346-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-609</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BETA-D-GLUCAN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526347-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040924</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004066150</companynumb>
    <primarysource>
      <qualification>3</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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526348-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-611</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>4 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>6 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>8 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>TABLET, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526349-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CIP04002533</companynumb>
    <primarysource>
      <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>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugauthorizationnumb>20835</drugauthorizationnumb>
        <drugdosagetext>35 MG ONCE WEEKLY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION (BUPROPION)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526350-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210536</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AORTIC ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRODUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO DIAPHRAGM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS PELVIC VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>522 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPECITABINE (CAPECITABINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN (TAMSULOSIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIANSERIN (MIANSERIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526351-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004JP15641</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN G DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>20 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>10 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>2000 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
        <drugtreatmentduration>57600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>400 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>200 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>550 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>400 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>500 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>200 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
        <drugtreatmentduration>17280</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>130 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>130 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>150 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>100</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526352-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_25397_2004</companynumb>
    <primarysource>
      <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>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugauthorizationnumb>17794</drugauthorizationnumb>
        <drugdosagetext>2 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugdosagetext>5 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIPOLEPT ^AVENTIS^</medicinalproduct>
        <drugdosagetext>100 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUXAL</medicinalproduct>
        <drugdosagetext>225 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526353-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-2004-034948</companynumb>
    <primarysource>
      <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>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2 D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980609</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526354-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE705612OCT04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACINETOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPPORTUNISTIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
        <drugtreatmentduration>718</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526355-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE268909DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONGENITAL CARDIAC SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL CENTRAL NERVOUS SYSTEM ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROCEPHALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>UP TO 225MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040411</drugenddate>
        <drugtreatmentduration>782</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526356-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE737402DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>200 MG 3X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040421</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMAC (PANTOPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE (BUDESONIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526357-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE778707DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>200 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPRAVENTRICULAR EXTRASYSTOLES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAFUSOR (GLYCERYL TRINITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526358-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE766906DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILACTONE (FUROSEMIDE/SPIRONOLACTONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOREM (TORASEMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULATARD NPH HUMAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIMAGON (CALCIUM CARBONATE/COLECALCIFEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON (SODIUM PICOSULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526359-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE865109DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATLANSIL (AMIODARONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526360-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE761706DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASASANTIN (ACETYLSALICYLIC ACID/DIPYRIDAMOLE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526361-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CIP04002282</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>COLLAGEN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA PRIMARY ATYPICAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY MONILIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugauthorizationnumb>20835</drugauthorizationnumb>
        <drugdosagetext>2.5 MG DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugdosagetext>150 MG DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS (CANDESARTAN CILEXETIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX (TEPRENONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL (ALFACALCIDOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526362-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-123038-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPARIN-INDUCED THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DANAPAROID SODIUM</medicinalproduct>
        <drugauthorizationnumb>20430</drugauthorizationnumb>
        <drugindication>HEPARIN-INDUCED THROMBOCYTOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526363-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030716</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>5869</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DACRYOCANALICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DACRYOSTENOSIS ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>89519</drugauthorizationnumb>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526364-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ERP04000384</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD FIBRINOGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DANTRIUM</medicinalproduct>
        <drugauthorizationnumb>17443</drugauthorizationnumb>
        <drugdosagetext>25 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE CRAMP</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>12 G/M3, 1 ONLY, IV NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUBAIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526365-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004091192</companynumb>
    <primarysource>
      <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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCRINE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugauthorizationnumb>19835</drugauthorizationnumb>
        <drugdosagetext>70 MG</drugdosagetext>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526366-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535288A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ECOTRIN REGULAR STRENGTH TABLETS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOVITAMINOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526367-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535339A</companynumb>
    <primarysource>
      <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 DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE POLACRILEX</medicinalproduct>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE (MINT)</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526368-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535476A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE (MINT)</medicinalproduct>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526369-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535991A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CALCINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526370-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535995A</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITRUCEL SUGAR-FREE SUSPENSION ORANGE</medicinalproduct>
        <drugbatchnumb>02M273</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISTARIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526371-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536687A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICHINIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526372-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359117A</companynumb>
    <primarysource>
      <qualification>5</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>PARACETAMOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526373-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0359215A</companynumb>
    <primarysource>
      <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>HYPERPYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DERMOVATE</medicinalproduct>
        <drugdosagetext>1.67G PER DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYALONE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526374-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100417</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DUPUYTREN'S CONTRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>8762</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526375-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-10909</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</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>20031015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDYFERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL (TRIMETAZIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELISOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRIDERM (TRINITRINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFERALGAN CODEINE (PARACETAMOL, CODEINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADANCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRALEVURE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526376-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-10785</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL EXAMINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</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>20031015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDYFERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL (TRIMETAZIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELISOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRIDERM (TRINITRINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFU-K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFERALGAN CODEINE (PARACETAMOL CODEINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADANCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRALEVURE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526377-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>25675</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENOCORTICAL INSUFFICIENCY CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTONOMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMBOCOR</medicinalproduct>
        <drugauthorizationnumb>18830</drugauthorizationnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526378-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2004A00665</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN INTRACRANIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugauthorizationnumb>20011</drugauthorizationnumb>
        <drugdosagetext>3.75 MG (3.75 MG, 1 IN 1 M)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040102</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVE COIL (INTRAUTERINE CONTRACEPTIVE DEVICE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526379-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2004A01011</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>20406</drugauthorizationnumb>
        <drugdosagetext>15 MG (15 MG, 1 IN 1 D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040413</drugenddate>
        <drugtreatmentduration>77</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISINOR RETARD (DILTIAZEM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROLOSIN (TAMSULOSIN HYDROCHLORIDE) (CAPSULES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARVEZIDE (KARVEA HCT)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526380-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE261807DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULTRASOUND ANTENATAL SCREEN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIHEXYPHENIDYL HCL</medicinalproduct>
        <drugauthorizationnumb>6773</drugauthorizationnumb>
        <drugdosagetext>2MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>2MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526381-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE529820APR04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS SUPERFICIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS LIMB</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugbatchnumb>2003P0086</drugbatchnumb>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>6 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugbatchnumb>2003P1123</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>0.625 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040723</drugenddate>
        <drugtreatmentduration>194</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugdosagetext>5 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040723</drugenddate>
        <drugtreatmentduration>194</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE ACETONIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE ACETONIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526382-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE884707JUL04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>803</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE VIA BREAST MILK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EISEN-II-SULFAT (FERROUS SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM (MAGNESIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARTUSISTEN (FENOTEROL HYDROBROMIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526383-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE773514OCT04</companynumb>
    <primarysource>
      <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>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>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OROKEN (CEFIXIME, TABLET)</medicinalproduct>
        <drugauthorizationnumb>50621</drugauthorizationnumb>
        <drugdosagetext>200MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040814</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INNOHEP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTUM (CEFTAZIDIME PENTAHYDRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN (AMOXICILLIN SODIUM/CLAVULANATE POTASSIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYOSTACINE (PRISTINAMYCIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIPARINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526384-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12758868</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID PULSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugbatchnumb>03C00104</drugbatchnumb>
        <drugdosagetext>1ST DOSE 05-MAY-04 (785 MG), REC'D 26 ML, THERAPY DURATION 8 MINS.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040505</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526385-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040823</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12679718</companynumb>
    <primarysource>
      <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>BLOOD LACTIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
        <drugtreatmentduration>206</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526386-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE187709NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUGULAR VEIN DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPIL FIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugdosagetext>10 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXEL (MILNACIPRAN, ,0)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KARDEGIC (ACETYLSALICYLATE LYSINE, ,0)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSANXIA (PRAZEPAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526387-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12781803</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-DYDRAMOL</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971019</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526388-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12789673</companynumb>
    <primarysource>
      <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>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031127</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040218</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031127</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
        <drugtreatmentduration>124</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIBLASTINE</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031127</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARACYTINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040218</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040219</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031127</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECTOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERMIXON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC 325</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040221</drugenddate>
        <drugtreatmentduration>128</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPHREN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
        <drugtreatmentduration>124</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FASTURTEC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040121</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031127</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
        <drugtreatmentduration>124</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526389-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12784518</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugdosagetext>CONSUMER TOOK 40 TABLETS ON 02-DEC-2004</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526390-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-BRISTOL-MYERS SQUIBB COMPANY-12789269</companynumb>
    <primarysource>
      <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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART VALVE INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLEOMYCIN SULFATE</medicinalproduct>
        <drugindication>HODGKIN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>HODGKIN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MECHLORETHAMINE HCL</medicinalproduct>
        <drugindication>HODGKIN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCARBAZINE</medicinalproduct>
        <drugindication>HODGKIN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugindication>HODGKIN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugindication>HODGKIN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINBLASTINE SULFATE</medicinalproduct>
        <drugindication>HODGKIN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>-4000 CGY IN 20  FRACTIONS</drugdosagetext>
        <drugindication>HODGKIN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526391-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>140797USA</companynumb>
    <primarysource></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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIMOZIDE</medicinalproduct>
        <drugauthorizationnumb>17473</drugauthorizationnumb>
        <drugdosagetext>2 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPERSONALISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIMOZIDE</medicinalproduct>
        <drugauthorizationnumb>17473</drugauthorizationnumb>
        <drugdosagetext>2 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEREALISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526392-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20010515</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200100464</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MILRINONE LACTATE</medicinalproduct>
        <drugauthorizationnumb>75830</drugauthorizationnumb>
        <drugdosagetext>25.6 )) DAY, DR</drugdosagetext>
        <drugindication>CARDIAC FAILURE ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010514</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILRINONE LACTATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACARDI/PIMOBENDAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILLISOL/NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DIURETICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526393-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9373</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>11719</drugauthorizationnumb>
        <drugdosagetext>50 MG, IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526394-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-UK-01275UK</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugauthorizationnumb>20938</drugauthorizationnumb>
        <drugdosagetext>15 MG (ONCE AT NIGHT) , PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-DANTHRAMER (DORBANEX)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL-D3 (LEKOVIT CA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX (ALENDRONATE SODUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL (PANADEINE CO)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE (BICALUTAMIDE0</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526395-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-DE-04683GL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOREA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELMISARTAN (TELMISARTAN)</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN (ACERTYLSALICYLIC ACID)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526396-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-CN-00439CN</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugauthorizationnumb>19085</drugauthorizationnumb>
        <drugdosagetext>IN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526397-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12398NB</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugdosagetext>40 MG, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WYTENS (GUANABENZ ACETATE )(TA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE) (TA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TINELAC (SENNOSIDE A+B) (TA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUGLUCON(GLIBENCLAMIDE) (TA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC (ALLOPURINOL) (TA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW K (POTASSIUM CHLORIDE) (TA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN (WQRFARIN) (TA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE (PREDNISOLONE BESILATE) (TA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL (CICLOSPORIN) (KA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN (BROTIZOLAM) (TA)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526398-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030521</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-338560</companynumb>
    <primarysource>
      <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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526399-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SOLVAY-00304004264</companynumb>
    <primarysource>
      <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>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPROMEL 25</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 150 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMIG</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 2.5 MILLIGRAM(S) AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 1.5 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 15 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526400-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-FF-00622FF</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugauthorizationnumb>20938</drugauthorizationnumb>
        <drugdosagetext>1 TABLET EACH TWO DAYS, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROSULF (CHONDROITIN SULFATE SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526401-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040316</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-362034</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSMISSION OF DRUG VIA SEMEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040213</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526402-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040721</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-375212</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040507</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040507</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugindication>NERVOUSNESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526403-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-UK-01321UK</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS (PROFESS STUDY 00015/0205/1) (TELMISARTAN) (TA) (TELMISARTAN)</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL (AGGRENOX REFERENCE) (TA)</medicinalproduct>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO (PLACEBO)</medicinalproduct>
        <drugdosagetext>200/25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugdosagetext>10 MG (NR)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031202</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL (METOPROLOL) (TA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HCTZ/TRIAMTERONE (TA)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526404-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12063NB</companynumb>
    <primarysource></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>MICARDIS CAPSULES (TELMISARTIN) (KA)</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugdosagetext>20 MG (NR); PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG (NR); PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526405-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040819</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-382537</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULNA FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>ACTUAL DOSE WAS 1650 MG TWICE DAILY GIVEN FROM DAYS ONE TO FOURTEEN OF A THREE WEEK CYCLE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040827</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040827</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>ACTUAL DOSE WAS 225 MG.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040827</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALDECOXIB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALIZAPRIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIMENHYDRINATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAMILLAN LIQUIDUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAXIPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526406-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-388134</companynumb>
    <primarysource>
      <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>ARTERIAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA-2A</medicinalproduct>
        <drugdosagetext>DAY 11 AND 18</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACARBAZINE</medicinalproduct>
        <drugdosagetext>ON DAY 1</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>FREQ = SID</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>FREQ = SID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugdosagetext>FREQ = SID</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526407-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-383029</companynumb>
    <primarysource>
      <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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1MG IRREGULARLY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALGIN</medicinalproduct>
        <drugdosagetext>20 AS NEEDED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAUMAL</medicinalproduct>
        <drugdosagetext>20 AS NEEDED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526408-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-383539</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526409-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-07631NB</companynumb>
    <primarysource></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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BI-SIFROL TABLETS (PRAMIPEXOLE DIHYDROCHLORIDE) (TA)</medicinalproduct>
        <drugauthorizationnumb>20667</drugauthorizationnumb>
        <drugdosagetext>1 MG (0.5 MG); ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040727</drugenddate>
        <drugtreatmentduration>53</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>0.4 (0.4 MG); PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20 MG (NR); PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040727</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCHOL (FLUVASTATIN SODIUM) (TA)</medicinalproduct>
        <drugdosagetext>30 MG (NR); PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040727</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEODOPASOL (MADOPAR) (TA)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526410-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ROCHE-388291</companynumb>
    <primarysource>
      <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 BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526411-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-381711</companynumb>
    <primarysource>
      <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>ACUTE PRERENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBANDRONIC ACID</medicinalproduct>
        <drugdosagetext>SCHEDULED DOSE OF 50MG DAILY, WAS NOT TAKEN EVERY DAY DURING THIS PERIOD.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040906</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBANDRONIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040824</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LETROZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040906</drugenddate>
        <drugtreatmentduration>161</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-DANTHRAMER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOZINAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526412-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-388275</companynumb>
    <primarysource>
      <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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040906</drugenddate>
        <drugtreatmentduration>82</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040906</drugenddate>
        <drugtreatmentduration>82</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040906</drugenddate>
        <drugtreatmentduration>82</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>TAKEN PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526413-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-387359</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</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>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugdosagetext>DOSE FORM: INJECTABLE SOLUTION DOSAGE: 1/3 AMPULE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUPRANE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIMBEX</medicinalproduct>
        <drugdosagetext>FORM: INJECTABLE SOLUTION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELOCURINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTOTHAL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>75MG OVER 5 MINUTES THEN 50MG/HOUR. FORMULATION REPORTED AS LYOPHILISED.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526414-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040924</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8949</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>76108</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PNEUMOCOCCAL POLYSACCHARIDE VACCINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526415-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-386561</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PNEUMONIA FUNGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>URBASON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS 1-0-0</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS 1-0-0</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDAREX</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS 1-0-0</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASIN</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS 0-0-0-1</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELOC-ZOK MITE</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS 1/2-0-1/2</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORVATON</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS 0-0-1</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIQUAEMIN INJ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526416-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-388323</companynumb>
    <primarysource>
      <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>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENICILLIN G</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugdosagetext>REPORTED AS ^CYPHER STENT^.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZELNIDIPINE</medicinalproduct>
        <drugdosagetext>REPORTED AS CALBLOCK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526417-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>104595ISR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTINEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLEMENT FACTOR C4 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLATIRAMER ACETATE</medicinalproduct>
        <drugauthorizationnumb>20622</drugauthorizationnumb>
        <drugdosagetext>20 MILLIGRAM SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526418-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-388421</companynumb>
    <primarysource>
      <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>EAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526419-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-388408</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILGRASTIM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526420-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-388362</companynumb>
    <primarysource>
      <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>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARVOVIRUS B19 SEROLOGY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COKENZEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAKTARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526421-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>105543ISR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLATIRAMER ACETATE</medicinalproduct>
        <drugauthorizationnumb>20622</drugauthorizationnumb>
        <drugdosagetext>20 MILLIGRAM SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ICHTHAMMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526422-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-388532</companynumb>
    <primarysource>
      <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>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526423-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-388531</companynumb>
    <primarysource>
      <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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980315</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526424-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-388491</companynumb>
    <primarysource>
      <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>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DENOSINE IV</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CYTOMEGALOVIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MODACIN</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBRACIN</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROID NOS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOSUPPRESSANT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526425-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12790994</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLEOMYCIN</medicinalproduct>
        <drugindication>ANAPLASTIC LARGE CELL LYMPHOMA T- AND NULL-CELL TYPES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINBLASTINE SULFATE</medicinalproduct>
        <drugindication>ANAPLASTIC LARGE CELL LYMPHOMA T- AND NULL-CELL TYPES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCARBAZINE</medicinalproduct>
        <drugindication>ANAPLASTIC LARGE CELL LYMPHOMA T- AND NULL-CELL TYPES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526426-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-388659</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>250 MG TAKEN AM AND 1500 MG AT BEDTIME.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526427-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-388761</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526428-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-388610</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANCORON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526429-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-388786</companynumb>
    <primarysource>
      <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>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>PROTOCOL MANDATED DOSE: 1250MG/M2 DAILY IN 2 DIVIDED DOSES FOR 24 WEEKS.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugdosagetext>50MG/M2 IV BOLUS ONCE EVERY 3 WEEKS (MAX 8 CYCLES).</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>60MG/M2 WITH HYDRATION ONCE EVERY 3 WEEKS (MAX 8 CYCLES).</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526430-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-388544</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BASILAR MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526431-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2004A03845</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HYDROCHLORIDE (PIOGLITAZONE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HYDROCHLORIDE (PIOGLITAZONE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030501</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HYDROCHLORIDE (PIOGLITAZONE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040528</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HYDROCHLORIDE (PIOGLITAZONE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
        <drugtreatmentduration>102</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOGLIBOSE (VOGLIBOSE)</medicinalproduct>
        <drugdosagetext>0.6 MG OR PLACEBO (3 IN 1 D) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
        <drugtreatmentduration>159</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BASEN (VOGLIBOSE)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BASEN (VOGLIBOSE)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970501</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BASEN (VOGLIBOSE)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BASEN (VOGLIBOSE)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BASEN (VOGLIBOSE)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030727</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BASEN (VOGLIBOSE)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040402</drugenddate>
        <drugtreatmentduration>250</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPHANATE (ASPIRIN/DIALUMINATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCREAS EXTRACT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRENOXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526432-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-388600</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBIVOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526433-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AMGEN-US102318</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>P011436</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526434-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041201131</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUSTATINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MASTOCYTOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526435-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-UK101260</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FARMORUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXRAZOXANE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526436-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2004A03839</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATIC HEART DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>15 MG (15 MG, 1 IN 1 D) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>169</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526437-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP06107</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugauthorizationnumb>18240</drugauthorizationnumb>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PILSICAINIDE</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOSIN</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040108</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526438-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-10905</companynumb>
    <primarysource>
      <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>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPHILUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR RETARDATION</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>20031015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUPRED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL  (TRIMETAZIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELISOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRIDERM (TRINITRINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFU K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFERALGAN CODEINE (PARACETAMOL CODEINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADANCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRALEVURE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526439-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-10906</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</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>20031015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL (TRIMETAZIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELISOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRIDERM (TRINITRINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFU K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFERALGAN CODEINE (PARACETAMOL CODEINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADANCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRALEVURE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526440-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041202493</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREPULSID</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526441-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20041103326</companynumb>
    <primarysource>
      <qualification>1</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREPULSID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACENTERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTAZINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTAZINE</medicinalproduct>
        <drugdosagetext>1/2 TABLET/DAY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugdosagetext>4X1/2 WEEKLY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORUNO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISTRANEURIN</medicinalproduct>
        <drugdosagetext>1 DOSE NOCTURNAL</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELDEPRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAMET</medicinalproduct>
        <drugdosagetext>2 MG NOCTURNAL</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET CONTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET CONTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANIDIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526442-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA04051</companynumb>
    <primarysource>
      <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>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRUFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZULENE SULFONATE SODIUM AND LEVOGLUTAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM ASPARTATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEQUITAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526443-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-0412ESP00019</companynumb>
    <primarysource>
      <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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ARRHYTHMIA SUPRAVENTRICULAR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SPONDYLOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA SUPRAVENTRICULAR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPONDYLOSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526444-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-10830</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</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>20031015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDYFERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL (TRIMETAZIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELISOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRIDERM (TRINITRINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFU K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFERALGAN CODEINE (PARACETAMOL CODEINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADANCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRALEVURE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPLICONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526445-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040305</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0403USA00626</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE DELAYED UNION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526446-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00749</companynumb>
    <primarysource>
      <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>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526447-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00194</companynumb>
    <primarysource>
      <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>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526448-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413330GDS</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</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>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugdosagetext>100 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>20 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526449-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0412USA01286</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDOMET-M</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526450-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0410USA03499</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</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>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041009</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRUFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526451-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00045</companynumb>
    <primarysource>
      <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>ABNORMAL SENSATION IN EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL POLYPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526452-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410621BFR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLINDNESS CORTICAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILS UNEQUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugauthorizationnumb>19537</drugauthorizationnumb>
        <drugdosagetext>1500 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN (FLUINDIONE)</medicinalproduct>
        <drugdosagetext>20 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODOPAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526453-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-604</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>20 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG 2X PER 1 WK, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACENOCOCOUMAROL (ACENOCOUMAROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB (CELECOXIB)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526454-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041200968</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>125/150 MG</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CLUSTER HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CLUSTER HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526455-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041201320</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RAYNAUD'S PHENOMENON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPITOMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPITOMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPITOMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>MIGRAINE PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMIG</medicinalproduct>
        <drugdosagetext>15 TO 22 TABLETS PER MONTH</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526456-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-MERCK-0411BEL00009</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040816</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526457-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA04050</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>36</patientweight>
      <patientsex>2</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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACARODERMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</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>ETODOLAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E NICOTINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM ASPARTATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANATON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENATETRENONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSENN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526458-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0412GBR00008</companynumb>
    <primarysource>
      <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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUILLAIN-BARRE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526459-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0411THA00002M</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL BRAIN DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSMISSION OF DRUG VIA SEMEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE IIA HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526460-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00002</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526461-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03578</companynumb>
    <primarysource>
      <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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE THYROIDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040727</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526462-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-605</companynumb>
    <primarysource>
      <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>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugdosagetext>200 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONALON (ALENDRONATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526463-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0411THA00002B1</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL BRAIN DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSMISSION OF DRUG VIA SEMEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>TYPE IIA HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526464-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LB-MERCK-0412USA01132</companynumb>
    <primarysource>
      <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>MYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526465-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0412FRA00016M</companynumb>
    <primarysource>
      <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>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGOHYDRAMNIOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL AGENESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526466-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0412FRA00016B1</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>-14</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGOHYDRAMNIOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL AGENESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526467-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03378</companynumb>
    <primarysource>
      <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>ACTINIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031006</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526468-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE204303JUN04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN G DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN M DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCHROMIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugbatchnumb>2003P1123</drugbatchnumb>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugbatchnumb>2003P1123</drugbatchnumb>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040629</drugenddate>
        <drugtreatmentduration>155</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugbatchnumb>2003P1123</drugbatchnumb>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX (CALCIUM PANTOTHENATE/NICOTINAMIDE/PYRIDOXINE HYDROC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROGLYCINE SULFATE COMPLEX (FERROGLYCINE SULFATE COMPLEX)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE IN PLASTIC CONTAINER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS (CORTICOSTEROID NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526469-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE712801DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMTUZUMAB OZOGAMICIN (GEMTUZUMAB OZOGAMICIN, INJECTION)</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526470-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE722301DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROENDOCRINE CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROENDOCRINE CARCINOMA OF THE SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID GLAND CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>200 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSUM (PERINDOPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORTIS ^GOEDECKE^ (ATORVASTATIN CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL (PANTOPRAZOLE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526471-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA00939</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </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>RECTAL PROLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526472-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00657</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526473-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F01200403507</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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN - SOLUTION - 236 MG</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>236 MG Q3W INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE - TABLET - 1800 MG</medicinalproduct>
        <drugdosagetext>1800 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB OR PLACEBO - SOLUTION</medicinalproduct>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE (RAMIPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (ACETOMINOPHEN, CAFFEINE, CODEINE PHOSPHATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526474-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0205USA02090</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EROSIVE DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERNATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEHISCENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MONARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE AND TRIAMTERENE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526475-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00605</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CAUDA EQUINA SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010704</drugenddate>
        <drugtreatmentduration>504</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010704</drugenddate>
        <drugtreatmentduration>504</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MUSCLE CRAMP</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010813</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526476-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA03498</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBIN BLOOD INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPANTIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE V HYPERLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LONGES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOBAY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHYL ICOSAPENTATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZBROMARONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041031</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526477-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0412FRA00017</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>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE VALERATE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526478-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A04200401129</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>20839</drugauthorizationnumb>
        <drugdosagetext>300 MG LOADING DOSE FOLLOWED BY 75 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERIAL STENT INSERTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE - GRANULE</medicinalproduct>
        <drugdosagetext>3 TO 5 TEASPOONS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELOC-ZOC (METOPROLOL SUCCINATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELIX PLUS (RAMIPRIL + HYDROCHLOROTHIAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526479-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0412GBR00042</companynumb>
    <primarysource>
      <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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIMOPTIC</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>1784</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEZAFIBRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526480-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0412AUS00033</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526481-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0407USA01745</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EXOSTOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLTX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526482-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00061</companynumb>
    <primarysource>
      <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>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOEXIPRIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526483-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0412GBR00089</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040823</drugenddate>
        <drugtreatmentduration>589</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526484-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00570</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENZYMATIC THERAPY TRIMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526485-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03879</companynumb>
    <primarysource>
      <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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</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>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526486-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-0412ESP00021</companynumb>
    <primarysource>
      <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>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526487-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0411USA00847</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526488-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MERCK-0412ESP00020</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC DISPLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031030</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031030</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORNOXICAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC DISPLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030211</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526489-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00881</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526490-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-12783346</companynumb>
    <primarysource>
      <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>ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL CONDITION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCREATININAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugindication>DRUG DEPENDENCE</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTAZIDE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYTONADIONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROMOMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526491-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12786273</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACIDOSIS HYPERCHLORAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCREATININAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FARMORUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDIOXANE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>AGRANULOCYTOSIS</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526492-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12788147</companynumb>
    <primarysource>
      <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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDREA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526493-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12788337</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugdosagetext>FORMULATION:  SUSPENSION</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526494-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-MERCK-0412SWE00013</companynumb>
    <primarysource>
      <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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
        <drugtreatmentduration>580</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526495-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01521</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AORTIC ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR CALCIFICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526496-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0412GBR00086</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>BUNDLE BRANCH BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORLISTAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>WEIGHT CONTROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526497-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A01200405462</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXERCISE TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XATRAL XL - (ALFUZOSIN HYDROCHLORIDE) - TABLET PR - 10 MG</medicinalproduct>
        <drugauthorizationnumb>21287</drugauthorizationnumb>
        <drugdosagetext>10 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526498-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00534</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526499-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00736</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526500-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00911</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526501-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00543</companynumb>
    <primarysource>
      <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>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526502-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00753</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>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526503-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
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    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526504-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXANTHEM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugauthorizationnumb>9768</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
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    </patient>
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  <safetyreport>
    <safetyreportid>4526505-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00945</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4526506-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00856</companynumb>
    <primarysource>
      <qualification>2</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4526507-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA02667</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>4526508-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00932</companynumb>
    <primarysource>
      <qualification>1</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>LARYNGEAL OEDEMA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>4526509-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-115379-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHANOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>4526510-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
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    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01062</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>SUDDEN CARDIAC DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
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        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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  <safetyreport>
    <safetyreportid>4526511-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
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    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <qualification>5</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>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
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        <drugenddate>20040930</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>4526512-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
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      <qualification>3</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>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT RELATED SECONDARY MALIGNANCY</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
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        <drugstartdate>20030901</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASTET</medicinalproduct>
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        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CPT-11</medicinalproduct>
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        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
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  <safetyreport>
    <safetyreportid>4526513-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
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    <receivedateformat>102</receivedateformat>
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    <receiptdate>20041130</receiptdate>
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    <primarysource>
      <qualification>1</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>
      <reaction>
        <reactionmeddrapt>CULTURE THROAT POSITIVE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
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  <safetyreport>
    <safetyreportid>4526514-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
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      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
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        <drugcharacterization>1</drugcharacterization>
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        <drugcharacterization>1</drugcharacterization>
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        <drugstartdateformat>102</drugstartdateformat>
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    <safetyreportid>4526515-3</safetyreportid>
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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>ACCIDENTAL OVERDOSE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugcharacterization>1</drugcharacterization>
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    <safetyreportid>4526516-5</safetyreportid>
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      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
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        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>75MG/M2 QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY NO DOSE FORM</medicinalproduct>
        <drugdosagetext>X-RAY THERAPY</drugdosagetext>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OS-CAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526517-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1717</companynumb>
    <primarysource>
      <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>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526518-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0132</companynumb>
    <primarysource>
      <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>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526519-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0410USA02029</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040125</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040118</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON PHOSPHATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030412</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON PHOSPHATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030512</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIACIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030412</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIACIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030512</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030512</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030412</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040507</drugenddate>
        <drugtreatmentduration>138</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040208</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526520-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100364</companynumb>
    <primarysource>
      <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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PSEUDOEPHEDRINE (PSEUDOEPHEDRINE)</medicinalproduct>
        <drugauthorizationnumb>73585</drugauthorizationnumb>
        <drugdosagetext>60 MG, NIGHTLY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRIAPISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526521-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-BRISTOL-MYERS SQUIBB COMPANY-12786224</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GERM CELL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLEOMYCIN SULFATE</medicinalproduct>
        <drugdosagetext>30 MG BOLUS, 90 MG CONTINUOUS INFUSION DAYS 1 TO 3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GERM CELL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526522-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12775649</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GATIFLO TABS 100 MG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALONAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526523-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099650</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.8748</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROGAINE</medicinalproduct>
        <drugbatchnumb>96JRM</drugbatchnumb>
        <drugauthorizationnumb>19501</drugauthorizationnumb>
        <drugdosagetext>1 ML QD, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HYPOTRICHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526524-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003-10-2256</companynumb>
    <primarysource>
      <qualification>3</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>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030711</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>600 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526525-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1810</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>120 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTASES TO CENTRAL NERVOUS SYSTEM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526526-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2004-0017808</companynumb>
    <primarysource>
      <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>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>MG</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526527-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>209399</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>225 MG, Q2W, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040903</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX (MOMETASONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEBREX (CELECOXIB)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526528-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>139758USA</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHAPPED LIPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>81225</drugauthorizationnumb>
        <drugdosagetext>3429 MILLIGRAM INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>428 MILLIGRAM 1XWK INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>125 MILLIGRAM INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugdosagetext>772 MILLIGRAM INTRAVENOUS (NOS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELDENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526529-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041008</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA01381</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODAL ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526530-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00719</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BARRETT'S OESOPHAGUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARTILAGE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICOBRACHIAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOLISTHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRODIURIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN ES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526531-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040910</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PIR 0409024B</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BRAIN DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXTROSE 70%</medicinalproduct>
        <drugbatchnumb>J4E029</drugbatchnumb>
        <drugdosagetext>UT DICT</drugdosagetext>
        <drugindication>CARDIAC OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526532-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041201346</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>9.5255</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCRATCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEETHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO VERBAL STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>19842</drugauthorizationnumb>
        <drugdosagetext>1/2 TEASPOON Q 6 HOURS</drugdosagetext>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041128</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526534-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24744</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.152</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugdosagetext>10 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526535-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW13405</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.0083</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR COLOUR CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR TEXTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526536-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24951</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.4932</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>6 CYCLES</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526537-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW15493</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREUTZFELDT-JAKOB DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526538-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24380</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>200 MG HS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBATROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526539-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24585</companynumb>
    <primarysource>
      <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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>200 MG HS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARNATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526540-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040507</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW09561</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.6683</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATIONS, MIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>200 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>100 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARISOPRODOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526541-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-035865</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040731</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526542-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004094057</companynumb>
    <primarysource>
      <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>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG(10 MG, 1 IN 1), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526543-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0411USA50121</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98.8842</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugauthorizationnumb>21042</drugauthorizationnumb>
        <drugdosagetext>25 MG/DAILY/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526544-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004091442</companynumb>
    <primarysource>
      <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>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526545-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0410USA50161</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST INTERFERENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugauthorizationnumb>21042</drugauthorizationnumb>
        <drugdosagetext>25 MG/DAILY/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROITIN SULFATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNISOLIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN (+) PHENYLEPHRINE HY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE (+) TRIAMTER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCYAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526546-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004090950</companynumb>
    <primarysource>
      <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>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DESQUAMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>300 MG (300 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHINE (COLCHINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526547-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0358172A</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD STEM CELL HARVEST FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>14691</drugauthorizationnumb>
        <drugdosagetext>SEE DOSAGE TEXT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILGRASTIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526548-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004197251DE</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA PAROXYSMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVODOPA (LEVODOPA)</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENPROCOUMON (PHENPROCOUMON)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL (METROPOLOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526549-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101082</companynumb>
    <primarysource>
      <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>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL-ALVEOLAR HYPOVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugdosagetext>0.5 MG (0.5 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040904</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526550-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004235932US</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITRODISC</medicinalproduct>
        <drugauthorizationnumb>20146</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE (VENLAFAXINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL (ETHANOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526551-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PERC20040064</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugauthorizationnumb>40330</drugauthorizationnumb>
        <drugdosagetext>4-5 TABS DAILY</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
        <drugdosagetext>4-5 TABS DAILY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526552-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PERC20040065</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugauthorizationnumb>40330</drugauthorizationnumb>
        <drugdosagetext>36 TABS ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526553-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100443</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>50467</drugauthorizationnumb>
        <drugdosagetext>35 MG (1 DAY), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1250 MG /M2* 2 (1 DAY), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>1.4 MG/M*2 (1 DAY), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCARBAZINE (PROCARBAZINE HCL) (PROCARBAZINE HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>100 MG/M*2 (1 DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>40 MG/M*2, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>200 MG/M*2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLEOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANULOCYTE COLONY STIMULATING FACTOR (GRANULOCYTE COLONY STIMULATING </medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526554-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004235932US</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITRODISC</medicinalproduct>
        <drugauthorizationnumb>20146</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE (VENLAFAXINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL (ETHANOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526555-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100129</companynumb>
    <primarysource>
      <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>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTTIN(SIMVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFLENZA VACCINE (INFLUENZA VACCINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526556-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040920</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004234943US</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOSTINEX</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>0.25 MG, TWICE WEEKLY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPROLACTINAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
        <drugdosagetext>AS NEEDED, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526557-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100127</companynumb>
    <primarysource>
      <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>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>(20 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL (ENALAPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL (SALMETEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETASONE 9BECLAMETASONE0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAZINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526558-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210837</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTROPIN AQ</medicinalproduct>
        <drugauthorizationnumb>20522</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugindication>BODY HEIGHT BELOW NORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526559-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2002-03-0887</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>150 MCG QWK SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>1200 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFERGEN</medicinalproduct>
        <drugdosagetext>15 MCG QD SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugdosagetext>600 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526560-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PERC20040066</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugauthorizationnumb>40341</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526561-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004081551</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</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>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE SUBCUTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>50784</drugauthorizationnumb>
        <drugdosagetext>500 MG (1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM (MONTELUKAST SODIUM)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>300 MG (100 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCATEROL HCL</medicinalproduct>
        <drugdosagetext>0.1 MG (0.05 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526562-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004028779</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugauthorizationnumb>20779</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV TEST POSITIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE W/LAMIVUDINE (LAMIVUDINE, ZIDOVUDINE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV TEST POSITIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HIV TEST POSITIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugindication>HIV TEST POSITIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526563-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2004A01283</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>30 MG (30 MG, 1 D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030710</drugenddate>
        <drugtreatmentduration>113</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BASEN (VOGLIBOSE)</medicinalproduct>
        <drugdosagetext>0.9 MG (0.9 MG, 1 D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526564-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101069</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>50670</drugauthorizationnumb>
        <drugdosagetext>500 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526565-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPG2004A00337</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>30 MG (30 MG, 1 IN 1 D) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>125</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDYN (TRIOBE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526566-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004095874</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>50784</drugauthorizationnumb>
        <drugdosagetext>500 MG (1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOCISTEINE (CARBOCISTEINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TULBUTEROL HYDROCHLORIDE (TULOBUTEROL HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526567-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2004A01021</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526568-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004085168</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>25 MG (1 IN 1 D)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPAMPERONE (PIPAMPERONE)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526569-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-UK-01276UK</companynumb>
    <primarysource></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>VITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugauthorizationnumb>20938</drugauthorizationnumb>
        <drugdosagetext>15 MG (NR, NOT REPORTED) PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL (ATENOLOL) (NR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LACIDIPINE (LACIDIPINE) (NR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN (SIMVASTATIN) (NR)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526570-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004018500</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>21267</drugauthorizationnumb>
        <drugdosagetext>200 MG (DAILY), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040303</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROXINE (LEVOTHROXINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526571-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041200481</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526572-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041200762</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FASCIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVANIC</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526573-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12415AU</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERSANTIN</medicinalproduct>
        <drugauthorizationnumb>12836</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugdosagetext>600 MCG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOBUTAMINE (DOBUTAMINE) (NR)</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRAMIL (CITALOPRAM HYDROBROMIDE) (TA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL (PERINDOPRIL) (TA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX (FRUSEMIDE) (TA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPRO (ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT (BUDESONIDE/EFORMOTEROL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526574-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041006613</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526575-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041200673</companynumb>
    <primarysource>
      <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>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOXACIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>PELVIC INFLAMMATORY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugindication>PELVIC INFLAMMATORY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERCILON</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERCILON</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030402</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526576-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041102784</companynumb>
    <primarysource>
      <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>BLOOD IMMUNOGLOBULIN M DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAPTOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOCET</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOCET</medicinalproduct>
        <drugindication>PROSTATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030215</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526577-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041201285</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526578-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041105114</companynumb>
    <primarysource>
      <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>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>TINEA PEDIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040725</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIHEXYPHENIDYL HCL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526579-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-JNJFOC-20041200465</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RESTLESSNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIADEL</medicinalproduct>
        <drugdosagetext>800-0-400 MG/DAY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526580-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041201664</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO VERBAL STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526581-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041007451</companynumb>
    <primarysource>
      <qualification>1</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>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUXAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526582-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041105096</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>THE PATIENT TOOK 25 TABLETS AT ONE TIME</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526583-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20040702326</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</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>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE TANNATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE TANNATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE TANNATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE TANNATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE TANNATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE TANNATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE TANNATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE TANNATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROTIZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROTIZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROTIZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526584-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-13017BP</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>20636</drugauthorizationnumb>
        <drugdosagetext>(200 MG) PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE (DIDANOSINE) (NR)</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE (STAVUDINE) (NR)</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526585-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20040702328</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNITRAZEPAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIHEXYPHENIDYL HCL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIHEXYPHENIDYL HCL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIHEXYPHENIDYL HCL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIHEXYPHENIDYL HCL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIZOLAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031125</drugenddate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031006</drugstartdate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031006</drugstartdate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUAZEPAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031224</drugstartdate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUAZEPAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031224</drugstartdate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUAZEPAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031224</drugstartdate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUAZEPAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031224</drugstartdate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROTIZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROTIZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526586-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20040701116</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNITRAZEPAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526587-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102133</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
        <drugauthorizationnumb>20607</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIOCOLCHICOSIDE (THIOCOLCHICOSIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526588-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-123166-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>DF ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526589-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F01200403795</companynumb>
    <primarysource></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>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>(OXALIPLATIN) - SOLUTION - 85 MG/M2</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>136 MG Q2W, INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>3140 MG (2250 MG/M2 IN 48 HOURS, WEEKLY), INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXATIN (BROMAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAT FLAS (MIRTAZAPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526590-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103050</companynumb>
    <primarysource>
      <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>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEGENER'S GRANULOMATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugdosagetext>0.25 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugdosagetext>1 DOSE FORM (DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526591-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040423</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F01200400858</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>(OXALIPLATIN - SOLUTION - 290 MG</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>290 MG Q3W, INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>(CAPECITABINE) - TABLET - 2300 MG</medicinalproduct>
        <drugdosagetext>2309 MG TWICE DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTIUM (PANTOPRAZOLE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORSODYL MOUTHWASH (CHLORHEXIDINE GLUCONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXOLON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526592-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-04321NB</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugdosagetext>40 MG, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
        <drugtreatmentduration>127</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUGLUCON (GLIBENCLAMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER (FAMOTIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENFILL R (INSULIN HUMAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS (ETIZOLAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526593-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101613</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20919</drugauthorizationnumb>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526594-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-DE-06004GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE (PRAMIPEXOLE DIHYDROCHLORIDE) (PRAMIPEXOLE)</medicinalproduct>
        <drugauthorizationnumb>20667</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526595-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-CN-00603CN</companynumb>
    <primarysource></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>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugdosagetext>(18 MCG) IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526596-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200401449</companynumb>
    <primarysource>
      <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>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20919</drugauthorizationnumb>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526597-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE749503DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INITIAL INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>300 MG 1X PER 1 DAY</drugdosagetext>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROMIDE</medicinalproduct>
        <drugdosagetext>1200 MG 1X PER 1 DAY</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526598-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030423</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BRISTOL-MYERS SQUIBB COMPANY-12252367</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030327</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CENTRUM FORTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526599-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12786695</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ACNEIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526600-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004088706</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48.9885</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROSACEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>5 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugdosagetext>37.5-25 (UNKNOWN), UNKNOWN</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRACYCLINE</medicinalproduct>
        <drugdosagetext>250 MG (UNKNOWN) UNKNOWN</drugdosagetext>
        <drugindication>CHALAZION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMIQUIMOD</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526601-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12745543</companynumb>
    <primarysource>
      <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>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526602-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12786398</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERURICAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526603-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE317117OCT03</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SARCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS (SIROLIMUS, TABLET)</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030113</drugenddate>
        <drugtreatmentduration>1395</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUNOSUPPRESSIVE AGENTS</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526604-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040924</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-239521</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENFILL 30R CHU</medicinalproduct>
        <drugdosagetext>20 IU, QD</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENFILL 30R CHU</medicinalproduct>
        <drugdosagetext>24 IU, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
        <drugtreatmentduration>258</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITOROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
        <drugtreatmentduration>313</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIKORANMART</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
        <drugtreatmentduration>313</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040521</drugenddate>
        <drugtreatmentduration>187</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526605-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101618</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugindication>AGITATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526606-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE086726OCT04</companynumb>
    <primarysource></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>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>2 MG 1X PER 1 DAY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>2 MG 1X PER 1 DAY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526607-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE727102DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>12-15 NG/ML TARGET TROUGH LEVELS;</drugdosagetext>
        <drugindication>PANCREAS ISLET CELL TRANSPLANT</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>3-6 NG/MLTARGET TROUGH LEVELS</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>3-6 NG/MLTARGET TROUGH LEVELS</drugdosagetext>
        <drugindication>PANCREAS ISLET CELL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526608-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108178</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugbatchnumb>FF4J26C</drugbatchnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526609-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0403NLD00027</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugdosagetext>40 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBASPIRIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526610-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ENTC2004-0223</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugauthorizationnumb>21485</drugauthorizationnumb>
        <drugdosagetext>TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526611-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9173</companynumb>
    <primarysource>
      <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>EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugauthorizationnumb>75705</drugauthorizationnumb>
        <drugdosagetext>0.5 MG PER MINUTE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugauthorizationnumb>75705</drugauthorizationnumb>
        <drugdosagetext>0.5 MG PER MINUTE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526612-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04090016</companynumb>
    <primarysource>
      <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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>T-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526613-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04120160</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (VITAMINS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526614-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04120095</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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526615-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04120043</companynumb>
    <primarysource>
      <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 POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL PILLS(ORAL CONTRACEPTIVE NOS)</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526616-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04110323</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>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKAEMIA PLASMACYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMZAR 9GEMCITABINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN (OXALIPLATIN )</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT (ERYTHROPOIETIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526617-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04120179</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSPLENISM ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LANGERHANS' CELL GRANULOMATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugbatchnumb>0295W</drugbatchnumb>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALIGNANT HISTIOCYTOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526618-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04110443</companynumb>
    <primarysource>
      <qualification>1</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>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEXPECTED THERAPEUTIC DRUG EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URATE NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>50 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526619-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096592</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugbatchnumb>10334C</drugbatchnumb>
        <drugauthorizationnumb>5845</drugauthorizationnumb>
        <drugdosagetext>1 SOFIGEL Q 4-6H, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL ITCH STOPPING SPRAY (DIPHENHYDRAMINE, ZINC ACETATE)</medicinalproduct>
        <drugbatchnumb>14424C</drugbatchnumb>
        <drugdosagetext>UNSPECIFIED, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUG, UNSPECIFIED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALOXIFENE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE ACETONIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESLORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZELASTINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL XINAFOATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE A DAY PLUS IRON (FERROUS FUMARATE, VITAMINS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEO BI-FLEX (CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526620-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04110279</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>200 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526621-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20010618</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0349629A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN FISSURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugbatchnumb>170A60 SAMPLES</drugbatchnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010427</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526622-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-07630-01</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOREA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROXINE FREE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugdosagetext>5 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMNESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMNESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526623-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411107951</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BINGE EATING</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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>15 MG/1 DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT (SERTRAILINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINERALS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINE DERMAL PATCH (NICOTINE RESIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINELL GUM (NICOTINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTROL (NICOTINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526624-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0412895A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESYREL</medicinalproduct>
        <drugdosagetext>50MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugdosagetext>2MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526625-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-04432</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICROGESTIN FE 1.5/30</medicinalproduct>
        <drugbatchnumb>63103A03</drugbatchnumb>
        <drugauthorizationnumb>75548</drugauthorizationnumb>
        <drugdosagetext>1 TABLET, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040618</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526626-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S03-USA-05298-01</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</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>20031112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526627-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-07700-01</companynumb>
    <primarysource>
      <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>MYOCLONUS</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>AZITHROMYCIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526628-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>R301145-PAP-USA</companynumb>
    <primarysource>
      <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>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCREASE (PANCRELIPASE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526629-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0517853A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MIGRAINE</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>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETANUS VACCINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAIN MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526630-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003041388</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugauthorizationnumb>19835</drugauthorizationnumb>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526631-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_991232959</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>114</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC HYPEROSMOLAR COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GANGRENE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCOAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSULIN RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEG AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC DIABETES INSIPIDUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>15 MG/1 DAY</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>15 MG/1 DAY</drugdosagetext>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROLIXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL (HALOPERIDOL DECONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STELAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMACINOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC (OMEPRAZOLE RATIOPHARM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN (GABAPENTIN PFIZER)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DDAVP (DESMOPRESSIN ACETATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTANE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526632-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102875</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102.0593</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS (ASCORBIC ACID, ERGOCALCIFEROL, FOLIC ACID, NICOTINAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526633-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040819</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0522813A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HILAR LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY MEDIASTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RELAFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TENDONITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040813</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526634-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040820</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0522931A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUDIOMIL</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBYAX</medicinalproduct>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526635-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0534636A</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>BRUXISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>37.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526636-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535576A</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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOARSENESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526637-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535738A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526638-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0536049A</companynumb>
    <primarysource>
      <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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>500MG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugdosagetext>10MG FOUR TIMES PER DAY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVASEN</medicinalproduct>
        <drugdosagetext>325MG PER DAY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>20U TWICE PER DAY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugdosagetext>20MG TWICE PER DAY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>40MG TWICE PER DAY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526639-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105438</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (1 IN 1 D)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS (ASCORBIC ACID, ERGOCALCIFEROL, FOLIC ACID, NICOTINAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526640-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536501A</companynumb>
    <primarysource>
      <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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526641-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536553A</companynumb>
    <primarysource>
      <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>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526642-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536582A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526643-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536635A</companynumb>
    <primarysource>
      <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>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041204</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIVELLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>Q10</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526644-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536785A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFAZOLIN</medicinalproduct>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526645-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536834A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526646-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536869A</companynumb>
    <primarysource>
      <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 CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</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>HYDRALAZINE</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>4526647-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEPFP-E-20040004</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040709</drugenddate>
        <drugtreatmentduration>106</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRONCHORETARD</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526648-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0297034A</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY ASPHYXIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POSTPARTUM DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526649-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0335816A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL NEEDLE STICK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSOPTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040612</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugdosagetext>125MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MENINGITIS VIRAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040614</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOCHOL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYASPIRIN</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOTIC STROKE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVEGYL</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040612</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526650-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103043</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLTERODINE LA (TOLTERODINE)</medicinalproduct>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>4 MG (4 MG, DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE (QUININE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER (ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C (VITAMIN C)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526651-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>002#4#2004-00281</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PPA/CPM-75/8MG (OTC) (PHENYLPROPANOLAMINE HCL, CHLORPHENIRAMINE MALEAT</medicinalproduct>
        <drugauthorizationnumb>18809</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526652-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102455</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY BLADDER EXCISION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
        <drugauthorizationnumb>20597</drugauthorizationnumb>
        <drugdosagetext>OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>OPEN ANGLE GLAUCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526653-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040709</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0339025A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH BREATHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MODACIN</medicinalproduct>
        <drugdosagetext>1G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040718</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROCIN</medicinalproduct>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA ASPIRATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040718</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLDEM 3A</medicinalproduct>
        <drugdosagetext>1000ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040712</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUBVITAN N</medicinalproduct>
        <drugdosagetext>5ML PER DAY</drugdosagetext>
        <drugindication>HYPOVITAMINOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
        <drugtreatmentduration>47</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROSE</medicinalproduct>
        <drugdosagetext>300ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040718</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE SOLUTION</medicinalproduct>
        <drugdosagetext>200ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040718</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526654-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040722</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0340350A</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
        <drugdosagetext>2500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugdosagetext>.2MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INADEQUATE CONTROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
        <drugtreatmentduration>245</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526655-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040917</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0346465A</companynumb>
    <primarysource>
      <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>MORBID THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLEDOMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>219</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040127</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526656-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0346468A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UTEMERIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526657-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0347024A</companynumb>
    <primarysource>
      <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOUGHMAC E</medicinalproduct>
        <drugdosagetext>1.5G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugdosagetext>.25MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRECIPITATED CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>3000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugdosagetext>36MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEISHI-KA-JUTSUBU-TO</medicinalproduct>
        <drugdosagetext>7.5G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERCINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526658-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0347078A</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOMIPRAMINE HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>115</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040517</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>1.2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
        <drugtreatmentduration>122</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>20040624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040630</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526659-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0348459A</companynumb>
    <primarysource>
      <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>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL CONDITION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVAMIN</medicinalproduct>
        <drugdosagetext>5MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAI-KENCHU-TO</medicinalproduct>
        <drugdosagetext>2.5MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLANAX</medicinalproduct>
        <drugdosagetext>1.6MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AUTONOMIC NERVOUS SYSTEM IMBALANCE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UBRETID</medicinalproduct>
        <drugdosagetext>5MG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSENN</medicinalproduct>
        <drugdosagetext>1.5G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLONEL</medicinalproduct>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526660-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0349429A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART VALVE CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPROLACTINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SECONDARY HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSIVE SYMPTOM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugdosagetext>50MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXOTAN</medicinalproduct>
        <drugdosagetext>2MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRAMIDE</medicinalproduct>
        <drugdosagetext>13.33MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMICRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIRNAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEILAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN S</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041009</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526661-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M24747</companynumb>
    <primarysource>
      <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>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DYNASTAT</medicinalproduct>
        <drugdosagetext>40MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREOPERATIVE CARE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526662-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M24750</companynumb>
    <primarysource>
      <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>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DYNASTAT</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREOPERATIVE CARE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526663-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0357950A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <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>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>350MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PL</medicinalproduct>
        <drugdosagetext>1G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040922</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOMIRON</medicinalproduct>
        <drugdosagetext>33.33MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040922</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITH</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUZYM</medicinalproduct>
        <drugdosagetext>90MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040922</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODESOXYCHOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526664-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M24749</companynumb>
    <primarysource>
      <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>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DYNASTAT</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREOPERATIVE CARE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526665-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0358095A</companynumb>
    <primarysource>
      <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>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACTOR V DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN DEGRADATION PRODUCTS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAMYLASAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLACTACIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MORBILLIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ALKALOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT D3</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526666-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0358933B</companynumb>
    <primarysource>
      <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>PILONIDAL CYST CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TALIPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040212</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040326</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUCIDINE CAP</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040109</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040330</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>3UNIT PER DAY</drugdosagetext>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFUROXIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NECYRANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICLOTYMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBROXOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526667-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0359290A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERINEAL FISTULA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030924</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugdosagetext>1250MG TWICE PER DAY</drugdosagetext>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030924</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526668-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0359330A</companynumb>
    <primarysource>
      <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>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526669-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CIP04002635</companynumb>
    <primarysource></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>FOREIGN BODY TRAUMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOOL ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugauthorizationnumb>19651</drugauthorizationnumb>
        <drugdosagetext>1200 MG THREE TIMES DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526670-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0359394A</companynumb>
    <primarysource>
      <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>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugdosagetext>2PUFF PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY FUNCTION TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526671-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103610</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>122.4712</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526672-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103798</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.514</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>20 MG (10 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526673-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>206881</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS MENINGOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>300 MG, Q4W, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR (SALMETEROL XINAFOATE, FLUTICASONE PROPIONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL NEBULIZER (ALBUTEROL SULFATE, ALBUTEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526674-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103412</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526675-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102606</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>122.9248</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526676-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0360007A</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELISOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526677-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-GLAXOSMITHKLINE-B0360159A</companynumb>
    <primarysource>
      <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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>3.6G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526678-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-GLAXOSMITHKLINE-B0360220A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BILIARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASCITES INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526679-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-GLAXOSMITHKLINE-B0360641A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE VIA BREAST MILK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>240</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>240</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526680-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0045448A</companynumb>
    <primarysource>
      <qualification>1</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>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526681-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04US000538</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIPSYCHOTIC DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDUCTION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QRS COMPLEX PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugauthorizationnumb>18027</drugauthorizationnumb>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXACARBAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526682-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105362</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (1 IN 1 D)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS (ASCORBIC ACID, ERGOCALCIFEROL, FOLIC ACID, NICOTINAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526683-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004231552US</companynumb>
    <primarysource>
      <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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG QD), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TENDONITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526684-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>209683</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugdosagetext>1 ML, 1/WEEK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526685-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102895</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERIPARATIDE (TERIPARATIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (VITAMINS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526686-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102739</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.3899</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYL SALICYLIC ACID USP BAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM (ESCITALOPRAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN (CYANOCOBALAMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE (ISOSORBIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526687-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102655</companynumb>
    <primarysource></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>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL XINAFOATE (SALMETEROL XINAFOATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526688-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-240936</companynumb>
    <primarysource>
      <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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN N</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526689-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-0729</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEARFULNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC INDUCED ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>96-48 QWK SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>1000-800 MG/D ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030520</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526690-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102554</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.5547</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MONARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESILATE (DOXAZOSIN MEXILATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES (ANTIHYPERTENSIVES)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526691-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004224722US</companynumb>
    <primarysource>
      <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>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, QD), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040708</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526692-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>003701</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEASONALE</medicinalproduct>
        <drugauthorizationnumb>21544</drugauthorizationnumb>
        <drugdosagetext>1.00 TABLET, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526693-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000255</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020108</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>4526694-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102580</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.4003</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALOXIFENE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526695-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101311</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>(1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526696-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101276</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526697-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004240538US</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BURSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE (ESOMEPRAZOLE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526698-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004231236US</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCESSIVE EXERCISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG (QD), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>10 MG (QD), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN SODIUM</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN (METFORMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS (ERGOCALCIFEROL/ASCORBIC ACID, FOLIC ACID, THIAMINE HYDR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLTERODINE TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE W/CHONDROITIN SULFATES (ASCORBIC ACID, CHONDROITIN SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526699-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000544</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526700-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000428</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <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>20011201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</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>20040801</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>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526701-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>206730</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERIAL STENT INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</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>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526702-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041201489</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONGENITAL OSTEODYSTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAELYX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526703-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207232</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID 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>20010726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</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>20040104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526704-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041201089</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526705-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041201273</companynumb>
    <primarysource>
      <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>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR ASSOCIATED FEVER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INCADRONATE DISODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526706-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041000984</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.31</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST WALL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVERSION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0330362</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526707-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040906249</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0208374</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
        <drugindication>URINARY INCONTINENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>ONE HALF TABLET DAILY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>5 TO 7.5 MG THREE TIMES A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLORINEF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526708-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040606849</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0403131;0327193</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526709-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041202094</companynumb>
    <primarysource>
      <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>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINE CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DELIRIUM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZALTOPROFEN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugdosagetext>1-2 DOSAGE FORM/DAY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>0.5 - 1.5 G/DAY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM PICOSULFATE</medicinalproduct>
        <drugdosagetext>5-15 MG/DAY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526710-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20041202238</companynumb>
    <primarysource>
      <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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FUSION SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YAWNING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526711-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041202395</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRAIN DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0406244</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXICET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXICET</medicinalproduct>
        <drugdosagetext>1 EVERY 4 HOURS</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526712-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041103873</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526713-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105375</companynumb>
    <primarysource>
      <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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526714-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20041007347</companynumb>
    <primarysource>
      <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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526715-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20040804268</companynumb>
    <primarysource>
      <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>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOLOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBICOX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526716-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20040902762</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031016</drugenddate>
        <drugtreatmentduration>53</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXIDINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ANOREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROTIZOLAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526717-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207869</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.3993</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526718-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>204101</companynumb>
    <primarysource>
      <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>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P01042</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P01042</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526719-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000426</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY 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>20010619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P30089</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526720-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000258</companynumb>
    <primarysource></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>COLLAPSE OF LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEELCHAIR USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PILL (NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526721-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000427</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</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>20030301</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>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526722-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE697429NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526723-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000557</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</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>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>19980101</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>20030801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526724-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000574</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.8331</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL 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>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526725-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-JNJFOC-20041201336</companynumb>
    <primarysource>
      <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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
        <drugtreatmentduration>233</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRLEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE DISKUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE DISKUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526726-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000579</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</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>19990401</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>4526727-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>173802</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P01021</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526728-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>205869</companynumb>
    <primarysource></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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN CARDIAC DEATH</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>20030403</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>20040920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGRYLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE A DAY VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRO-DUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526729-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE697129NOV04</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANT SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PACEMAKER COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>5 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526730-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE867909DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OPTIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>20377</drugauthorizationnumb>
        <drugdosagetext>6 G 1X PER 72 HR, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>72</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526731-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE868109DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>100 MG 1X PER 1 DAY</drugdosagetext>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526732-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE365206APR04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.01</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AXILLARY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY LIVER ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY LYMPH GLAND ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVIT (VITAMINS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE ^LECIVA^ (TRIAMCINOLONE ACETONIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE (RAMIPRIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526733-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE191501NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMMUNICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLAT AFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED SELF-CARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUDGEMENT IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF LIBIDO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL AVOIDANT BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526734-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101239</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.2043</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM (LITHIUM)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526735-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004040233</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.9572</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20919</drugauthorizationnumb>
        <drugdosagetext>20 MG, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040305</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526736-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A118566</companynumb>
    <primarysource>
      <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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK LEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QRS COMPLEX PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIPRASIDONE (ZIPRASIDONE)</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>(80 MG)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>(100 MG)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>(40 MG)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>(250 MG)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526737-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102386</companynumb>
    <primarysource>
      <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>ANTICONVULSANT TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>8762</drugauthorizationnumb>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>(1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526738-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100533</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GLOBAL AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACIDI (ACETYSALICYLIC ACID)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526739-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100988</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526740-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100529</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.2554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART VALVE REPLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 AS NECESSARY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS (ASCORBIC ACID), ERGOCALCIFEROL, FOLIC ACID, NICOTINAMID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES (ANTIHYPERTENSIVES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526741-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>235779K04USA</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN WEEKS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526742-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000558</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.2971</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</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>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>PJ0043</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526743-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12788907</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE IMMEASURABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE ROLLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILACOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526744-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-000851</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMRING</medicinalproduct>
        <drugauthorizationnumb>21367</drugauthorizationnumb>
        <drugdosagetext>MG, QD, VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040315</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526745-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000573</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P30067</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526746-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KII-2004-0014164</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STUPOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>19516</drugauthorizationnumb>
        <drugdosagetext>SEE TEXT, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526747-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OMPQ-PR-0412S-1403</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugauthorizationnumb>18956</drugauthorizationnumb>
        <drugdosagetext>170 ML, SINGLE DOSE I.A.</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE SODIUM SUCCINATE (SOLU-MEDROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL (BENADRYL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526748-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>140811USA</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>20622</drugauthorizationnumb>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526749-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KII-2004-0014176</companynumb>
    <primarysource>
      <qualification>3</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>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPIL FIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNORING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL (ETHANOL)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526750-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KII-2004-0014175</companynumb>
    <primarysource>
      <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>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABILE BLOOD PRESSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILLARY LIGHT REFLEX TESTS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINE DERIVATIVES</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVOUSNESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526751-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KII-2004-0014178</companynumb>
    <primarysource>
      <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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QRS COMPLEX SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>Q-BID-LA (GUAIFENESIN)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPROPYLENE GLYCOL MONOMETHYL ETHER (ETHER, SOLVENT)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINE DERIVATIVES (BENZODIAZEPINE DERIVATIVES)</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526752-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KII-2004-0014174</companynumb>
    <primarysource>
      <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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHUNT MALFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>19516</drugauthorizationnumb>
        <drugdosagetext>Q8H PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>HS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526753-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-01-1781</companynumb>
    <primarysource>
      <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>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORTISOL FREE URINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLAT AFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOHYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITUITARY-DEPENDENT CUSHING'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN STRIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>120 MCG QWK SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>1000 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526754-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004US-00413</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA MYCOPLASMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFACLOR</medicinalproduct>
        <drugauthorizationnumb>64155</drugauthorizationnumb>
        <drugdosagetext>UNK MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526755-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200420931BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE THORACIC PROCEDURE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>20304</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526756-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-386561</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CANDIDA PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPERGILLUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA FUNGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>URBASON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS 1-0-0</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS 1-0-0</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDAREX</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS 1-0-0</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASIN</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS 0-0-0-1</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELOC-ZOK MITE</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS 1/2-0-1/2</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORVATON</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS 0-0-1</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIQUAEMIN INJ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526757-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0214</companynumb>
    <primarysource>
      <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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EULEXIN</medicinalproduct>
        <drugauthorizationnumb>18554</drugauthorizationnumb>
        <drugdosagetext>250 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526758-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24784</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.39</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART VALVE REPLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
        <drugauthorizationnumb>17970</drugauthorizationnumb>
        <drugdosagetext>20 MG QD</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526759-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415828BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.8331</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORIGINAL ALKA-SELTZER TABLETS</medicinalproduct>
        <drugbatchnumb>A3B12F</drugbatchnumb>
        <drugdosagetext>650 MG, IRR, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526760-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415689BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>289864F</drugbatchnumb>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>220 MG, ONCE,ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526761-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-062-0282485-00</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>74086</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526762-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415427BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.5651</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTMENOPAUSAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>294094K</drugbatchnumb>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>440 MG, HS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>294094K</drugbatchnumb>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>440 MG, HS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526763-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-062-0282487-00</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>74086</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526764-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE739202DEC04</companynumb>
    <primarysource>
      <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>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL TEAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>CURRENTLY TAPERING, NOW ON 25 MG DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526765-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-062-0282488-00</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>74086</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526766-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW17845</companynumb>
    <primarysource>
      <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 PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAT NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAS GANGRENE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN S DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOMEDIASTINUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAROPIN</medicinalproduct>
        <drugauthorizationnumb>20533</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020814</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526767-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24426</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.6162</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>20 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526768-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-062-0282489-00</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>74086</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526769-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW22287</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.2252</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526770-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24994</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERIAL STENT INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>5 MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>10 MG DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526771-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-062-0282490-00</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>74086</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POSITIVE CARDIAC INOTROPIC EFFECT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526773-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-062-0281951-00</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>74086</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POSITIVE CARDIAC INOTROPIC EFFECT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526774-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-062-0281969-00</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>74086</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526775-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-062-0281970-00</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>74086</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526776-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-062-0282475-00</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>74086</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526777-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-062-0282478-00</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>74086</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526778-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-062-0282479-00</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>74086</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526779-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-062-0282480-00</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>74086</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POSITIVE CARDIAC INOTROPIC EFFECT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526780-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-062-0282481-00</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>74086</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POSITIVE CARDIAC INOTROPIC EFFECT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526781-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-062-0282482-00</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>74086</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POSITIVE CARDIAC INOTROPIC EFFECT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526782-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-2004-035946</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM THORAX ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugauthorizationnumb>20038</drugauthorizationnumb>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSULFAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTITHYMOCYTE IMMUNOGLOBULIN (RABBIT) (ANTITHYMOCYTE IMMUNOGLOBULIN (R</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526783-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-2004-031448</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE LYMPHOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE MORPHOLOGY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugauthorizationnumb>20038</drugauthorizationnumb>
        <drugdosagetext>54 MG, 1X/DAY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIOTEPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTITHYMOCYTE IMMUNOGLOBULIN (RABBIT) (ANTITHYMOCYTE IMMUNOGLOBULIN (R</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN (FLUCONAZOLE) CAPSULE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBENIN (BETAMIPRON, PANIPENEM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT (LEVOFLOXACIN) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISODINE (POVIDONE-IODINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE (CARBOCISTEINE) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VEEN-F (CALCIUM CHLORIDE ANHYDROUS, SODIUM ACETATE, MAGNESIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526784-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A044-002-005333</companynumb>
    <primarysource>
      <qualification>3</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKAEMIA PLASMACYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</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</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>15 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE ANHYDROUS (FERROUS SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMOL (APOREX)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRALAX (MICROLAX)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526785-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24757</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugdosagetext>40 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526786-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>J081-002-001829</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANIRAPID (METILDIGOXIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526787-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24789</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRATION OF IMPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENSORCAINE</medicinalproduct>
        <drugauthorizationnumb>70968</drugauthorizationnumb>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526788-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24869</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526789-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW22708</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.782</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUILLAIN-BARRE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE ROOT LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugbatchnumb>2000053810</drugbatchnumb>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugbatchnumb>C300408</drugbatchnumb>
        <drugdosagetext>400 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526790-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2002UW16050</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCADIAN RHYTHM SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>200 TO 400 MG</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>200 TO 400 MG</drugdosagetext>
        <drugindication>MENTAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526791-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW22782</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41.27</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>50 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526792-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CERZ-10724</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB 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>19961217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526793-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SUS1-2004-00801</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL XR 10</medicinalproduct>
        <drugauthorizationnumb>21303</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526794-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A044-002-005079</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526795-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZONI002078</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEGRAN (ZONISAMIDE)</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEGRAN (ZONISAMIDE)</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEGRAN (ZONISAMIDE)</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526796-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-FRA-07962-01</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>200 MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE (ZOPICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL (TRIMETAZIDINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIPARINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526797-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>430083K04USA</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugdosagetext>12 MG/M2, 1 IN 3 MONTHS</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET-CR (SINEMET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACRODANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C (ASCORBIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX (B-KOMPLEX ^LECIVA^)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPERICUM (HYPERICUM EXTRACT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE SULFATE (GLUCOSAINE SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526798-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-09-1041</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98.8842</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE LYMPHOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLAST CRISIS IN MYELOGENOUS LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugbatchnumb>3IOK409</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19871001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19921001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugbatchnumb>3IOK409</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugbatchnumb>3IOK409</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19871001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugbatchnumb>3IOK409</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526799-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-FRA-06920-01</companynumb>
    <primarysource>
      <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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>20 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526800-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210437</companynumb>
    <primarysource>
      <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>IMMUNODEFICIENCY WITH INCREASED IMMUNOGLOBULIN M</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugdosagetext>1/WEEK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526801-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-FRA-07953-01</companynumb>
    <primarysource>
      <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>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPLEX (ESCITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>15 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPLEX (ESCITALOPRAM)</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526802-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>209812</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040818</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526803-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-GER-07158-01</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRALEX (ESCITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>15 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FEAR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRALEX (ESCITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>15 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRALEX (ESCITALOPRAM)</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FEAR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRALEX (ESCITALOPRAM)</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>4526804-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>0400050EN0020P</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCASPAR</medicinalproduct>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4526805-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>0400051EN0020P</companynumb>
    <primarysource>
      <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>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCASPAR</medicinalproduct>
        <drugdosagetext>2275 IU IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526806-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>0400043EN0020P</companynumb>
    <primarysource>
      <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>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCASPAR</medicinalproduct>
        <drugdosagetext>3975 IU IM DAY 1 AND 8</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVERA QD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC BID PRN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526807-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210753</companynumb>
    <primarysource>
      <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>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugindication>WALDENSTROM'S MACROGLOBULINAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526809-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-UKI-07954-01</companynumb>
    <primarysource>
      <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>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRALEX (ESCITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUGYNON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526810-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004059295</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.7403</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20882</drugauthorizationnumb>
        <drugdosagetext>1800 MG (1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYNEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC-D 12 HOUR</medicinalproduct>
        <drugdosagetext>2 IN 1 D</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugdosagetext>2 IN 1 D</drugdosagetext>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>2 IN 1 D</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM (MONTELUKAST SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE (ESOMEPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALAMINE/CAMPHOR/DIPHENHYDRAMINE (CALAMINE, CAMPHOR, DIPHENHYDRAMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526811-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102854</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE IMMEASURABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELL DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRECANCEROUS CELLS PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMEAR CERVIX ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULNAR NERVE PALSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALDECOXIB (VALDECOXIB) (VALDECOXIB)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>1800 MCG (75 MCG, 24 IN 1 D), TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE (VENLAFAXINE)</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPINE (CYLOBENAZAPRINE)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-COMPLEX (VITAMIN B-COMPLEX)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSEUDOEPHEDRINE (PSEUDOEPHEDRINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION (BUPROPION)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526812-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104869</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526813-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104292</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC-D 12 HOUR</medicinalproduct>
        <drugauthorizationnumb>21150</drugauthorizationnumb>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526814-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102856</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugauthorizationnumb>19835</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526815-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099661</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN KAPSEAL</medicinalproduct>
        <drugauthorizationnumb>84349</drugauthorizationnumb>
        <drugdosagetext>300 MG (100 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526816-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004040838</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.0604</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>600 MG (300 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN (ROSUVASTATIN)</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRIDOXINE HCL</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE (EZETIMIBE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN (DOXEPIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS (ESTROGENS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL (FISH OIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (VITAMINS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINERALS NOS (MINERALS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICON FORTE (FOLIC ACID, MINERALS NOS, VITAMINS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RETINOL (RETINOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POTASSIUM (POTASSIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE (CALCIUM CITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526817-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102454</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.0593</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>8762</drugauthorizationnumb>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugdosagetext>25MG ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526818-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004084170</companynumb>
    <primarysource>
      <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>NO ADVERSE DRUG EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526819-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0412108813</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526820-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20421130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004081893</companynumb>
    <primarysource>
      <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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>160 MG (80 MG, 2 IN 1 D),</drugdosagetext>
        <drugindication>AGITATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>AGGRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugindication>HALLUCINATION, AUDITORY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526821-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-YUG-07887-01</companynumb>
    <primarysource>
      <qualification>3</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>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526822-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004078726</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.2971</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526823-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101387</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITTING OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>(10 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>100 MG (100 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KAOPECTATE (PECTIN, KAOLIN)</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526824-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RS004851-CDN</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDRIOL (TESTOSTERONE UNDECAONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE (ZOPICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL (PETHIDINE HYDROCHLOIRIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526825-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-05086</companynumb>
    <primarysource>
      <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>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FERRICET (WATSON LABORATORIES) (SODIUM FERRIC GLUCONATE) INJECTION, 62</medicinalproduct>
        <drugauthorizationnumb>20955</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FERRICET (WATSON LABORATORIES) (SODIUM FERRIC GLUCONATE) INJECTION, 62</medicinalproduct>
        <drugauthorizationnumb>20955</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDENOFALK (BUDESONIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALOFALK (AMINOSALICYCLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPHAKOMP-B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526826-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097045</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </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>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>80 MG (40 MG, 2 IN 1 D),</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526827-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103586</companynumb>
    <primarysource>
      <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>5 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>10 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
        <drugdosagetext>50 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
        <drugdosagetext>20 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLINDED THERAPY (BLINDED THERAPY)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS (ASCORBIC ACID, ERGOCALCIFEROL, FOLIC ACID, NICOTINAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526828-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-00509</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>3.50 MG</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOCT (ZOLPIDEM TARTRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEHEPAN (CYANOCOBALAMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELTISON (PREDNISONE, CALCIUM PHOSPHATE, MAGNESIUM TRISILICATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526829-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105565</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugauthorizationnumb>19885</drugauthorizationnumb>
        <drugdosagetext>40 MG (20 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526830-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004201252JP</companynumb>
    <primarysource>
      <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>CYCLOTHYMIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION OF REFERENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIFORM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THOUGHT BROADCASTING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE MALEATE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526831-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-036114</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526832-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105392</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526833-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-US2004-08303</companynumb>
    <primarysource>
      <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>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION LOCALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL (SILDENAFIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526834-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-US2004-08213</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN (OXYGEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526835-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105304</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>1 DF EVERY DAY (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>1 DF EVERY DAY (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526836-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-US2004-08229</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526837-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MAG-2004-0000309</companynumb>
    <primarysource></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>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAZOCINE LACTATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVAMIN (PROCHLORPERAZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYSIOSOL (SODIUM CHLORIDE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN (AMBROXOL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOLVON (BROMHEXINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPROPHYLLINE (DIPROPHYLLINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAMEZIN ^KNOLL^ (CEFAZOLIN SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526838-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_23652_2003</companynumb>
    <primarysource>
      <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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEVETEN</medicinalproduct>
        <drugauthorizationnumb>20738</drugauthorizationnumb>
        <drugdosagetext>300 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELISOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKOR FORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIASCLEDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANAKAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANQUITAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARYTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OROCAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526839-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_25448_2004</companynumb>
    <primarysource>
      <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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEVETEN</medicinalproduct>
        <drugauthorizationnumb>20738</drugauthorizationnumb>
        <drugdosagetext>DF PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526840-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103944</companynumb>
    <primarysource>
      <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>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIPOTRIOL (CALCIPOTRIOL)</medicinalproduct>
        <drugdosagetext>TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE (BETAMETASONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINE RESIN (NICOTINE RESIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526841-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BL008619</companynumb>
    <primarysource></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>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINIMS PREDNISOLONE SODIUM PHOSPHATE (PREDNISOLONE SODIUM PHOSPHATE)</medicinalproduct>
        <drugauthorizationnumb>40065</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526842-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0277507-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526843-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102833</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THRAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526844-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-04P-087-0282405-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVORANE LIQUID FOR INHALATION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2-5 %</drugdosagetext>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000302</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526845-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0282641-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526846-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_25463_2004</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RENIVACE</medicinalproduct>
        <drugauthorizationnumb>18998</drugauthorizationnumb>
        <drugdosagetext>DF PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526847-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100788</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526848-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_25457_2004</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>19221</drugauthorizationnumb>
        <drugdosagetext>1 TAB QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANACRIST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLENDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX /SCH/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526849-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0282484-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSYLLIUM HYDROPHILIC MUCILLOID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLCELLULOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUCINDOLOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUS HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526850-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0282653-00</companynumb>
    <primarysource></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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERIDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526851-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000419</companynumb>
    <primarysource>
      <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>OLIGODENDROGLIOMA</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>20030101</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>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526852-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105297</companynumb>
    <primarysource>
      <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>HYPERTRIGLYCERIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-MEDROL</medicinalproduct>
        <drugauthorizationnumb>11757</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020501</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>60 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020701</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020701</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>300 MG (BID), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugdosagetext>80 MG (BID), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>6 DOSE FORM (TID), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IDARUBICIN HCL</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPARAGINASE (ASPARAGINASE)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526853-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04KOR0260</companynumb>
    <primarysource>
      <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 DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRASTAT</medicinalproduct>
        <drugauthorizationnumb>20912</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE (CLOPIDOGREL SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526854-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004231940FR</companynumb>
    <primarysource>
      <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>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS NECROTISING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTAZIDE (HYDROCHLOROTHIAZIDE, SPIRONOLACTONE)</medicinalproduct>
        <drugauthorizationnumb>12616</drugauthorizationnumb>
        <drugdosagetext>1 TBSP (1 TBSP, DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REPAGLINIDE (REPAGLINIDE) (REPAGLINIDE)</medicinalproduct>
        <drugdosagetext>8 MG (DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASOBRAL (CAFFEINE, DIHYDROERGOCRYPTINE MESILATE)</medicinalproduct>
        <drugdosagetext>2 DOSE FORMS (DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE MITE (FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526855-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>K200401849</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL WALL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARM AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY THORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY ON ORAL CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB HYPOPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDETTE-21</medicinalproduct>
        <drugauthorizationnumb>18668</drugauthorizationnumb>
        <drugdosagetext>TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVONELLE (LEVONORGESTREL)</medicinalproduct>
        <drugdosagetext>TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020703</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526856-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004217372BR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH INJECTABLE CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526857-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>K200401852</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SONATA</medicinalproduct>
        <drugauthorizationnumb>20859</drugauthorizationnumb>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526858-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004212867BR</companynumb>
    <primarysource></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>GLIOBLASTOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>20280</drugauthorizationnumb>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BLOOD GROWTH HORMONE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLACUR (ESTRADIOL VALERATE, NORGESTREL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526859-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103963</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526860-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2003FR03152</companynumb>
    <primarysource>
      <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>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISUDYNE</medicinalproduct>
        <drugauthorizationnumb>21119</drugauthorizationnumb>
        <drugindication>RETINAL NEOVASCULARISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021003</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526861-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2002092475FR</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EROSIVE BALANITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LICHEN PLANUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
        <drugauthorizationnumb>20597</drugauthorizationnumb>
        <drugdosagetext>OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTEOL (BENZALKONIUM CHLORIDE, CARTEOLOL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAZOLAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526862-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-05-0364</companynumb>
    <primarysource>
      <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugauthorizationnumb>21165</drugauthorizationnumb>
        <drugdosagetext>1 TAB</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REACTINE (CETIRIZINE HCL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526863-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102587</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526864-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1673</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugauthorizationnumb>20762</drugauthorizationnumb>
        <drugdosagetext>2/NARE BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYP</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526865-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413268GDS</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>118</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>400 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINCOCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYPRODOL ^RIO ETHICALS^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXPIGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN-D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE MITE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526866-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102127</companynumb>
    <primarysource>
      <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>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugauthorizationnumb>12151</drugauthorizationnumb>
        <drugdosagetext>1 DF (DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>300 MG (300 MG DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL (CLOPIDOGREL)</medicinalproduct>
        <drugdosagetext>1 DF (DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MADOPAR (BENSERAZIDE HYDROCHLORIDE, LEVODOPA)</medicinalproduct>
        <drugdosagetext>3 DF (MG, DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>10 MG (10 MG, DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORANDIL (NICORANDIL)</medicinalproduct>
        <drugdosagetext>20 MG (10 MG, EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960616</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526867-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP06153</companynumb>
    <primarysource></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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
        <drugauthorizationnumb>17970</drugauthorizationnumb>
        <drugdosagetext>20 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526868-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102113</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>20753</drugauthorizationnumb>
        <drugdosagetext>25 MG (25 MG, EVER DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526870-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102136</companynumb>
    <primarysource>
      <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>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVERSION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526872-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102925</companynumb>
    <primarysource>
      <qualification>2</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>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDIABETIC DRUG (UNSPECIFIED)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526873-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-10-0998</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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugauthorizationnumb>21165</drugauthorizationnumb>
        <drugdosagetext>5 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZADITEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526875-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP06076</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>19627</drugauthorizationnumb>
        <drugdosagetext>350 MG DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUSCULAX</medicinalproduct>
        <drugdosagetext>3 MG DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANEST</medicinalproduct>
        <drugdosagetext>275 UG DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPHEDRIN</medicinalproduct>
        <drugdosagetext>8 MG DAILY</drugdosagetext>
        <drugindication>BLOOD PRESSURE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFAZOLIN</medicinalproduct>
        <drugdosagetext>1 G DAILY IVD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526876-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102817</companynumb>
    <primarysource>
      <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>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIACEREIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526878-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05587</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.3</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DELAYED RECOVERY FROM ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>19627</drugauthorizationnumb>
        <drugdosagetext>3 ML/KG/HR IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526879-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105293</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLYCOPEPTIDE ANTIBIOTIC RESISTANT ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID SOLUTION, STERILE (LINEZOLID)</medicinalproduct>
        <drugauthorizationnumb>21131</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526881-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AC00906</companynumb>
    <primarysource></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>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOLUM</medicinalproduct>
        <drugdosagetext>25 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526882-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102114</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXEMESTANE TABLET (EXEMESTANE)</medicinalproduct>
        <drugauthorizationnumb>20753</drugauthorizationnumb>
        <drugdosagetext>ORAL/ 2,5 YEARS ONGOING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER FEMALE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526883-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE05136</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA SUPRAVENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXANTHEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IDROCLOROTIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOLO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANRENONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITALIS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526885-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02894</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLTERODINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOBUNOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPENTOLATE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526887-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP06179</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugauthorizationnumb>50706</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526888-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AC00912</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION POTENTIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugdosagetext>40 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROLUM</medicinalproduct>
        <drugdosagetext>1 MG DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELEKTINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526891-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP04970</companynumb>
    <primarysource></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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>500 MG, DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CERVIX NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CERVIX NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAXIPARINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTACINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIPRALEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEOMYCINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIFICIAL TEARS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOBETADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAKTOZIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMFEEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526893-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP04026</companynumb>
    <primarysource></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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUROTEP  JANSSEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOLONG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526894-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410396BBE</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FACTOR VIII INHIBITION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526896-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6011856F</companynumb>
    <primarysource>
      <qualification>3</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>NIASPAN</medicinalproduct>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
        <drugdosagetext>750 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526897-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410396BBE</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526899-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410395BBE</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526900-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>601634</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD S/D</medicinalproduct>
        <drugdosagetext>0.9 GM; QM; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANE MITE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>3 LEAD TRANSFER STE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>500 ML EVA TPN CONTAINER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFUSION SET 270CM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526901-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THYR-10034</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYROGEN</medicinalproduct>
        <drugauthorizationnumb>20898</drugauthorizationnumb>
        <drugdosagetext>0.9 MG QD IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DIAGNOSTIC PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRISEQUENS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINIDRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UN ALFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROPRAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526903-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410350BBE</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENKTSU GLOBULIN-I, NICHI HAKU</medicinalproduct>
        <drugdosagetext>INTRVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MILLER FISHER SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugindication>GUILLAIN-BARRE SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526904-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003-09-0125</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>34</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORNEAL DEPOSITS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN SULFATE</medicinalproduct>
        <drugauthorizationnumb>50039</drugauthorizationnumb>
        <drugdosagetext>QH/DAY OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>EYE INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugdosagetext>2 DROPS QD OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>EYE INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELESTONE PHOSPHATE OPHTHALMIC SOLUTION</medicinalproduct>
        <drugdosagetext>4-3 DROPS QD OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>ANTIINFLAMMATORY THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROMETHOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUSOPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OFLOXACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526907-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SUS1-2004-00826</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugauthorizationnumb>20049</drugauthorizationnumb>
        <drugdosagetext>375 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>21 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SELENASE(SELENIDE SODIUM)</medicinalproduct>
        <drugdosagetext>25 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZINKAMIN (ZINC)</medicinalproduct>
        <drugdosagetext>15 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526908-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200409204</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUMINAR-5</medicinalproduct>
        <drugbatchnumb>A783812</drugbatchnumb>
        <drugdosagetext>100 ML DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHOLECYSTECTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOFLURANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAPEINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526910-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05492</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>20578</drugauthorizationnumb>
        <drugdosagetext>10.8 MG Q3MO SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugdosagetext>80 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERSANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERMION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN S</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOBAY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FASTIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526911-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410171BSV</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMIMUNE N 10%</medicinalproduct>
        <drugbatchnumb>26N1702</drugbatchnumb>
        <drugdosagetext>100 G, TOTAL DAILY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>WEGENER'S GRANULOMATOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526914-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-0181</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>5 MIU</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROFERON-A</medicinalproduct>
        <drugdosagetext>9 MIU</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA INJECTABLE</medicinalproduct>
        <drugdosagetext>3 MIU</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYUREA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526930-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-03556</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST (BCG - IT (CONNAUGHT)),AVENTIS PASTEUR LTD.,LOT NOT REP,I6</medicinalproduct>
        <drugdosagetext>(81.0 MG), B.IN.,BLADDER</drugdosagetext>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEZAFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCLOPYRRAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526933-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-02141</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST (BCG - IT (CONNAUGHT)),AVENTIS PASTEUR LTD.</medicinalproduct>
        <drugdosagetext>81 MG, B.IN.,BLADDER</drugdosagetext>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040512</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFCAPENE PIVOXIL HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526935-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-03821</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BOVINE TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST (BCG - IT (CONNAUGHT)),AVENTIS PASTEUR LTD.,LOT NOT REP,I</medicinalproduct>
        <drugdosagetext>B.IN.</drugdosagetext>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526937-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-03014</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST (BCG - IT (CONNAUGHT)),AVENTIS PASTEUR LTD.</medicinalproduct>
        <drugdosagetext>(81.0 MG), B.IN.,BLADDER</drugdosagetext>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGAFUR-URACIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526939-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-03700</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST (BCG - IT (CONNAUGHT)),AVENTIS PASTEUR LTD.,LOT NOT REP,I10</medicinalproduct>
        <drugdosagetext>81 MG / WEEK, I.VES.,BLADDER</drugdosagetext>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040818</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526940-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-03699</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETHRAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST (BCG - IT (CONNAUGHT)),AVENTIS PASTEUR LTD.</medicinalproduct>
        <drugdosagetext>81 MG, B.IN.,BLADDER</drugdosagetext>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526941-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-122308-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TICE BCG</medicinalproduct>
        <drugdosagetext>INTRAVESICAL</drugdosagetext>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526944-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>403425410/PHRM2004FR02798</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AK-FLUOR, 10% , AKORN</medicinalproduct>
        <drugbatchnumb>21274</drugbatchnumb>
        <drugdosagetext>5ML, ONCE/SINGLE, IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANGIOGRAM RETINA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOPTOL, EYE DROPS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOSYNEPHRYNE EYE DROPS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYDRIATICUM EY DROPS, NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATHYMIL , TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OGAST, CAPSULE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526945-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>403725410/PHRM2004FR02894</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AK-FLUOR INJECTION, AKORN</medicinalproduct>
        <drugbatchnumb>21274</drugbatchnumb>
        <drugdosagetext>5ML, ONCE/SINGLE,IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANGIOGRAM RETINA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526946-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A403525410/PHRM2004FR02851</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AK-FLUOR, 10%, AKORN</medicinalproduct>
        <drugbatchnumb>21264</drugbatchnumb>
        <drugdosagetext>1 DF, ONCE/SINGLE, IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANGIOGRAM RETINA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANAKAN, TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATISPRAY, SOLUTION AEROSOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA, TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC, POWDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IKOREL, TABLET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526947-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2004GB00475</companynumb>
    <primarysource></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>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugauthorizationnumb>73025</drugauthorizationnumb>
        <drugdosagetext>50 MG , QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRINE (ACETYLSALICYLIC ACID0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526948-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410392BBE</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENINGITIS ASEPTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMUNEX</medicinalproduct>
        <drugdosagetext>70 G, QD, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DERMATOMYOSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526950-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>240637</companynumb>
    <primarysource>
      <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>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>AORTIC ANEURYSM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526957-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1003517</companynumb>
    <primarysource></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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>450MG BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526958-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1003282</companynumb>
    <primarysource></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>AREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>12.5 MG TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE OPHTHALMIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORBITOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526959-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1003159</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugauthorizationnumb>86009</drugauthorizationnumb>
        <drugdosagetext>25 MG QHS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE TABLETS 75 MG</medicinalproduct>
        <drugdosagetext>75 MG QHS. ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526960-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041008</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1003025</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugauthorizationnumb>76187</drugauthorizationnumb>
        <drugdosagetext>75MCG QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLMITRIPTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526961-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D01200404475</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY RELATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASBURICASE - SOLUTION - 0.2 MG/KG</medicinalproduct>
        <drugdosagetext>0.2 MG/KG QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASBURICASE - SOLUTION - 0.2 MG/KG</medicinalproduct>
        <drugdosagetext>0.2 MG/KG QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TUMOUR LYSIS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300 MG  QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040925</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTAZ (CEFTAZIDIME)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAFCILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE (DOCUSATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSLO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526962-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THYM-10354</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.1219</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CALCINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>TH089-01</drugbatchnumb>
        <drugdosagetext>116  MG QD  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526963-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE512610DEC03</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>11</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COAGULATION FACTOR VIII LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REFACTO</medicinalproduct>
        <drugbatchnumb>19321A51A</drugbatchnumb>
        <drugdosagetext>300 IU DAILY PROPHYLAXIS, INTRAVENOUS; UNKNOWN DOSE EVERY OTHER DAY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REFACTO</medicinalproduct>
        <drugbatchnumb>19304A51A</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526965-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>040818-0000411</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENOTROPHOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANHEMATIN</medicinalproduct>
        <drugbatchnumb>08994Z7</drugbatchnumb>
        <drugdosagetext>40 MG; QD; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PORPHYRIA ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANHEMATIN</medicinalproduct>
        <drugbatchnumb>08996Z7</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugbatchnumb>033830036</drugbatchnumb>
        <drugdosagetext>5 MG; UNKNOWN; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PORPHYRIA ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugbatchnumb>033830041</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526968-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>040818-0000412</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.2252</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIA URINE IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANHEMATIN</medicinalproduct>
        <drugbatchnumb>08994-Z7</drugbatchnumb>
        <drugdosagetext>200 MG; TIW;</drugdosagetext>
        <drugindication>PORPHYRIA ACUTE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugbatchnumb>03383-00036</drugbatchnumb>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PORPHYRIA ACUTE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugbatchnumb>03383-00041</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugbatchnumb>03383-00043</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FULVITE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526969-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>040818-0000410</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENOTROPHOMONAS SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANHEMATIN</medicinalproduct>
        <drugbatchnumb>08996-Z7</drugbatchnumb>
        <drugdosagetext>150 MG;BID;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PORPHYRIA ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANHEMATIN</medicinalproduct>
        <drugbatchnumb>08994-Z7</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugbatchnumb>033830029</drugbatchnumb>
        <drugdosagetext>5 ML,  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PORPHYRIA ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugbatchnumb>033830036</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugbatchnumb>033830041</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugbatchnumb>033830043</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugbatchnumb>033830064</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROSE INFUSION FLUID 5%</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526972-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE531120APR04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>24</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMARTHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REFACTO</medicinalproduct>
        <drugbatchnumb>17375A51</drugbatchnumb>
        <drugdosagetext>30 U/KG (MINOR BLEEDS) TO 50 U/KG (MAJOR BLEEDS); ON DEMAND THERAPY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REFACTO</medicinalproduct>
        <drugbatchnumb>16351A51</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REFACTO</medicinalproduct>
        <drugbatchnumb>19533A51A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REFACTO</medicinalproduct>
        <drugbatchnumb>19351A51A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REFACTO</medicinalproduct>
        <drugbatchnumb>16891A51</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526974-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>240800</companynumb>
    <primarysource>
      <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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FACTOR VII DEFICIENCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526976-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THYM-10366</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANT SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>T-LYMPHOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugdosagetext>2 MG/KG DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ORGAN TRANSPLANT</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugdosagetext>2 MG/KG DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>THYMUS DISORDER</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526978-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ALB/04/07/USA</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.4911</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugbatchnumb>04319-00045</drugbatchnumb>
        <drugdosagetext>50 ML, ONCE, I.V.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OLIGURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526979-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004094424</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROLACTINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOSTINEX</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>1 MG (1 MG, DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROLACTINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOSTINEX</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>1 MG (1 MG, DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROLACTINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOSTINEX</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>1 MG (1 MG, DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROLACTINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOSTINEX</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>1 MG (1 MG, DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROLACTINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526980-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA00055</companynumb>
    <primarysource>
      <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>BRAIN STEM INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST WALL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERCOSTAL NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULAR SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040610</drugenddate>
        <drugtreatmentduration>117</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACAL</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>ALDACTAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526981-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004094057</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526982-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041008</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA01341</companynumb>
    <primarysource>
      <qualification>1</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>AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526983-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20021008</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-MERCK-0210NZL00211</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>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020201</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526984-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0311USA02526</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA PAROXYSMAL NOCTURNAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011110</drugenddate>
        <drugtreatmentduration>284</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011110</drugenddate>
        <drugtreatmentduration>284</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETRIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIBACTERIAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MOTION SICKNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE AND ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANALGESIC EFFECT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
        <drugtreatmentduration>336</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL MSD LP</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIBACTERIAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIBACTERIAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIBACTERIAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>VITAMIN B12 DEFICIENCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526985-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004092974</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMAVERT</medicinalproduct>
        <drugauthorizationnumb>21106</drugauthorizationnumb>
        <drugdosagetext>10 MG (DAILY) SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ACROMEGALY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526986-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004092934</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZULFIDINE EN-TABS</medicinalproduct>
        <drugauthorizationnumb>7073</drugauthorizationnumb>
        <drugdosagetext>500 MG (250 MG, 1 IN 2 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (CORTICOSTEROIDS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526987-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003186495JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.5224</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN HYDROCHLORIDE (EPIRUBICIN HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>50778</drugauthorizationnumb>
        <drugdosagetext>UNK (130 MG, CYCLIC), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>UNK (900 MG, CYCLIC), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>8 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROTONE (AZASETRON HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>10 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GASTER (FAMOTIDINE)</medicinalproduct>
        <drugdosagetext>20 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031106</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526988-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040318</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>194266</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (SORTIS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526989-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000094</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINA BIFIDA</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>20040514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040609</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>4526990-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA02433</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-CARDIAC CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>4526991-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000415</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
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      <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>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
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  <safetyreport>
    <safetyreportid>4526992-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040811</receiptdate>
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    <companynumb>MPS1-10273</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
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        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDURAZYME</medicinalproduct>
        <drugindication>MUCOPOLYSACCHARIDOSIS I</drugindication>
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  <safetyreport>
    <safetyreportid>4526993-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
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    <companynumb>GB-MERCK-0410GBR00306</companynumb>
    <primarysource>
      <qualification>3</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>DROP ATTACKS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>1298</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>1298</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000313</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526994-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004087791</companynumb>
    <primarysource>
      <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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE (BUMETANIDE0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACICLOVIR (ACICLOVIR0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL (BISOPROLOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526995-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040312</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0403USA01341</companynumb>
    <primarysource>
      <qualification>1</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUTHYROID SICK SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOLISTHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR PSEUDOANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030827</drugenddate>
        <drugtreatmentduration>252</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030827</drugenddate>
        <drugtreatmentduration>252</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLTX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030709</drugenddate>
        <drugtreatmentduration>112</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030320</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040206</drugenddate>
        <drugtreatmentduration>324</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINSEED OIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030313</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526996-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>MPS1-10274</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>14.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDURAZYME</medicinalproduct>
        <drugdosagetext>8.7 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MUCOPOLYSACCHARIDOSIS I</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526997-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099909</companynumb>
    <primarysource>
      <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>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526998-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102785</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugauthorizationnumb>19835</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPUETUIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4526999-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>MPS1-10277</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>14.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TONGUE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDURAZYME</medicinalproduct>
        <drugbatchnumb>458530A</drugbatchnumb>
        <drugdosagetext>8.7 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MUCOPOLYSACCHARIDOSIS I</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527000-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0411GBR00192</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE CRAMP</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND CODEINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIHYDROCODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527001-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00087</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE PRERENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527002-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103970</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN GASTROINTESTINAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHIC PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM (BROMAZEPAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527003-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-MERCK-0412NZL00011</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527004-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>MPS1-10279</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>20.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDURAZYME</medicinalproduct>
        <drugdosagetext>11.6 MG QWK IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527005-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00084</companynumb>
    <primarysource>
      <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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527006-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103919</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISLOCATION OF VERTEBRA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHIC PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM (BROMAZEPAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527007-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0412GBR00099</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE AND CHOLECALCIFEROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE PAMOATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527008-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00508</companynumb>
    <primarysource>
      <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>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULAR PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIGASTRIC DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENPROCOUMON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020918</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020918</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LETROZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527009-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030929</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0310USA00134</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>136</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL WALL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAUSTIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIASTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOARSENESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT CREPITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABYRINTHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527010-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102815</companynumb>
    <primarysource>
      <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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugauthorizationnumb>19835</drugauthorizationnumb>
        <drugdosagetext>10 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN (LOSARTAN0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSIGLIAZONE (ROSIGLITAZONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE (PYRIDOXINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL (LISONOPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN (METFORMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527011-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040903</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>MPS1-10280</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>19.9583</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDURAZYME</medicinalproduct>
        <drugdosagetext>11.6 MG QWK IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MUCOPOLYSACCHARIDOSIS I</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDURAZYME</medicinalproduct>
        <drugdosagetext>11.6 MG QWK IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MUCOPOLYSACCHARIDOSIS I</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527012-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040924</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>MPS1-10282</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>15.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS A</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDURAZYME</medicinalproduct>
        <drugdosagetext>0.58 MG QWK IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MUCOPOLYSACCHARIDOSIS I</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040513</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527013-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004084199</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>8762</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527014-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>MPS1-10285</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>15.24</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDURAZYME</medicinalproduct>
        <drugdosagetext>11.6 MG QWK IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MUCOPOLYSACCHARIDOSIS I</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527015-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004041970</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPROLACTINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGONADISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORTIS (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE HEXAHYDROBENZOATE (TESTOSTERONE HEXAHYDROBENZOATE )</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527016-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>MPS1-10288</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDURAZYME</medicinalproduct>
        <drugdosagetext>2.9 MG QWK IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MUCOPOLYSACCHARIDOSIS I</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527017-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00083</companynumb>
    <primarysource>
      <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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527018-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00082</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527019-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103897</companynumb>
    <primarysource>
      <qualification>3</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>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELDOX (CAPSULES) (ZIPRASIDONE)</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>40 MG (20 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HALLUCINATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HALLUCINATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIOBE (CYANOCOBALAMIN, FOLIC ACID, PYRIDOXINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM (ALANDRONATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITOXIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN (WARFARIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527020-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00088</companynumb>
    <primarysource>
      <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>CORONARY ARTERY INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527021-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA01676</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527022-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>MPS1-10289</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>35.8342</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORNEAL OPACITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDURAZYME</medicinalproduct>
        <drugdosagetext>0.58 MG/KG QWK IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527023-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01104</companynumb>
    <primarysource>
      <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527024-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00613</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527025-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004087280</companynumb>
    <primarysource></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 DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDURAN (DOXAZOSIN)</medicinalproduct>
        <drugauthorizationnumb>19668</drugauthorizationnumb>
        <drugdosagetext>4 MG (4 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527026-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00086</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527027-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>MPS1-10290</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>12</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDURAZYME</medicinalproduct>
        <drugdosagetext>1200 UNITS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527028-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00892</companynumb>
    <primarysource>
      <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>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527029-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00999</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527030-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004087111</companynumb>
    <primarysource>
      <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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>5 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527031-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00895</companynumb>
    <primarysource>
      <qualification>5</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527032-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01185</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527033-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SI-MERCK-0412HUN00006</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040514</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040514</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527034-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01156</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527035-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004088663</companynumb>
    <primarysource>
      <qualification>1</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>CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELDOX (CAPSULE) (ZIPRASIDONE)</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>120 MG (2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOMETASONE FUROATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINUSELECT (HOMEOPATICS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENIDE SODIUM (SELENIDE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINES (ANTIHISTAMINES)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527036-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097807</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SINUS ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROTINOLOL HYDROCHLORIDE (AROTINOLOL HYDROCHLORIDE)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527037-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100475</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527038-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101444</companynumb>
    <primarysource>
      <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>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527040-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101738</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN E INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRANIAL NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>5 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527041-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01075</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID FACTOR INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527046-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0076</companynumb>
    <primarysource>
      <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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugauthorizationnumb>21165</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527048-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-062-0282491-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>74086</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527051-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-062-0282492-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>74086</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527052-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE255303DEC04</companynumb>
    <primarysource>
      <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>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>10.4MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>15MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527053-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-062-0282493-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL INJECTION (DOBUTAMINE HYDROCHLORIDE INJECTION (DOBUTAMI</medicinalproduct>
        <drugauthorizationnumb>74086</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527056-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-062-0282494-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>74086</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527057-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-062-0282495-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>74086</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527058-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-062-0282496-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>74086</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527059-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NLWYE257503DEC04</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527060-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-062-0282483-00</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>74086</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POSITIVE CARDIAC INOTROPIC EFFECT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527061-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US099673</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>181.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527062-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104775</companynumb>
    <primarysource>
      <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>EYE REDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROSACEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>50 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527063-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102906</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTONOMIC NERVOUS SYSTEM IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATIONS, MIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE (SERTRALINE)</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION (BUPROPION)</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE (VENLAFAXINE)</medicinalproduct>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRACETAM (PIRACETAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527064-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101373</companynumb>
    <primarysource>
      <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>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYASTHENIA GRAVIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527065-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-05001</companynumb>
    <primarysource>
      <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>ATRIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>87792</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SIGNET-RING CELL CARCINOMA</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527066-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100296</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>5 MG (5 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORTIS (ATORVASTATIN)</medicinalproduct>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANDOLARPIL (TRANSDOLAPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEMASTINE (CLEMASTINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST (MONTELUKAST)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EBASTINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527067-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004087618</companynumb>
    <primarysource>
      <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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE (VORICONAZOLE)</medicinalproduct>
        <drugauthorizationnumb>21266</drugauthorizationnumb>
        <drugindication>LUNG ABSCESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527068-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103335</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>5 MG (2.5 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL (CANCESARTAN CILEXETIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527069-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003181809BR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANT SITE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN (SOMATROPIN)</medicinalproduct>
        <drugauthorizationnumb>20280</drugauthorizationnumb>
        <drugdosagetext>0.6 MG (QD)</drugdosagetext>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021226</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527070-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-MERCK-0412AUT00003</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOPHYLLINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOPHYLLINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[COMPOSITION UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527101-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US095258</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527102-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US095424</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040404</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527103-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US095998</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURKITT'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527104-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US096105</companynumb>
    <primarysource></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>EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA (MALT TYPE)</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527105-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US096394</companynumb>
    <primarysource>
      <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>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030207</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527106-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US096579</companynumb>
    <primarysource>
      <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>CUTANEOUS LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUNISAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527107-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US096605</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527108-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELITIS TRANSVERSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>0034471</drugbatchnumb>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
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        <drugstartdate>20030107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
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  <safetyreport>
    <safetyreportid>4527109-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US096758</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 IN 1 WEEKS, SC; 25 MG, 2 IN 1 WEEKS, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 IN 1 WEEKS, SC; 25 MG, 2 IN 1 WEEKS, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
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        <drugenddate>20040605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527110-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US096846</companynumb>
    <primarysource></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>NON-HODGKIN'S LYMPHOMA STAGE II</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>D033465</drugbatchnumb>
        <drugdosagetext>2 IN 1 WEEKS</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527111-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US093629</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CUTANEOUS VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527112-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US093773</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527113-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US093849</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE/ALBUTEROL SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527114-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US094159</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOSIS FUNGOIDES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527115-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US094196</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>D034570</drugbatchnumb>
        <drugdosagetext>50 MG, 2 IN 1 WEEKS, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527116-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US094498</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030828</drugstartdate>
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        <drugenddate>20040924</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID/CALCIUM CARBONATE / CITRIC ACID/COLECALCIFEROL (ASCORBIC</medicinalproduct>
      </drug>
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  <safetyreport>
    <safetyreportid>4527117-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US094907</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>4527118-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US094951</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 IN 1 WEEKS</drugdosagetext>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
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    <safetyreportid>4527119-9</safetyreportid>
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    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedate>20041201</receivedate>
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    <companynumb>US095069</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
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        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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        <drugstartdate>20001101</drugstartdate>
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  <safetyreport>
    <safetyreportid>4527120-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US095120</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
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      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
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        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
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        <drugenddate>20040609</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALDECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527121-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US091273</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMESULIDE (NIMESULIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM (RISEDRONATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527122-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US091393</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CUTANEOUS LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527123-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US092018</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>D034567</drugbatchnumb>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527124-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US092161</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527125-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US092370</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527126-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US092701</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BETA HAEMOLYTIC STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15 MG, 1 IN 1 WEEKS, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527127-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US092705</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527128-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US093100</companynumb>
    <primarysource></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>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527129-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US093270</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527130-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US093512</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527131-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>20031000067</companynumb>
    <primarysource>
      <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>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugbatchnumb>023105</drugbatchnumb>
        <drugauthorizationnumb>83312</drugauthorizationnumb>
        <drugdosagetext>25 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugbatchnumb>023105</drugbatchnumb>
        <drugauthorizationnumb>83312</drugauthorizationnumb>
        <drugdosagetext>25 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030602</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>4527132-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>20040600313</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
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        <drugdosagetext>25 MG QID IV</drugdosagetext>
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        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040609</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
        <drugdosagetext>75 ,G Q3HR IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040609</drugenddate>
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    </patient>
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    <safetyreportid>4527133-3</safetyreportid>
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    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040605</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>20040600317</companynumb>
    <primarysource>
      <qualification>3</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>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugbatchnumb>03L02DA</drugbatchnumb>
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        <drugdosagetext>50 MG ONCE IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
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        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>4527134-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>20040700342</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>10.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugbatchnumb>1063113</drugbatchnumb>
        <drugauthorizationnumb>83312</drugauthorizationnumb>
        <drugdosagetext>12.5 MG ONCE IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527135-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>20040800368</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>158.759</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugauthorizationnumb>83312</drugauthorizationnumb>
        <drugdosagetext>4 MG DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEPERIDINE (BAXTER)</medicinalproduct>
        <drugdosagetext>15 MG DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugdosagetext>12.5 MG DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021025</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527136-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>20040800377</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GANGRENE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugauthorizationnumb>83312</drugauthorizationnumb>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030602</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527137-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>20040800378</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>12.7007</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERONEAL NERVE PALSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugauthorizationnumb>83312</drugauthorizationnumb>
        <drugdosagetext>12.5 MG ONCE IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527142-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>C-04-0040</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugbatchnumb>26454A</drugbatchnumb>
        <drugauthorizationnumb>74602</drugauthorizationnumb>
        <drugdosagetext>1TBS, 4 TIMES/DAY, ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040527</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527143-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040722</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004UW17509</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugbatchnumb>401034</drugbatchnumb>
        <drugauthorizationnumb>71050</drugauthorizationnumb>
        <drugdosagetext>1 MG/10MINUTES</drugdosagetext>
        <drugindication>SPINAL LAMINECTOMY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527174-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>800134</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL MYCOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugauthorizationnumb>17512</drugauthorizationnumb>
        <drugdosagetext>2 L; QD; INTRAPERITONEAL</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugdosagetext>6 L; QD; INTRAPERITONEAL</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOMECHOICE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527175-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101532</companynumb>
    <primarysource></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>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugauthorizationnumb>5845</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VARICELLA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527176-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101528</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANEXAMIC ACID (TRANEXAMIC ACID)</medicinalproduct>
        <drugauthorizationnumb>19281</drugauthorizationnumb>
        <drugdosagetext>1000 MG PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENORRHAGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527177-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-05057</companynumb>
    <primarysource>
      <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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION POTENTIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE (WATSON LABORATORIES) (DIPYRIDAMOLE) TABLET, 50 MG</medicinalproduct>
        <drugauthorizationnumb>87160</drugauthorizationnumb>
        <drugdosagetext>75 MG, TID</drugdosagetext>
        <drugindication>TRANSIENT ISCHAEMIC ATTACK</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>100 MG/M2 , DAILY</drugdosagetext>
        <drugindication>TRANSIENT ISCHAEMIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IDARUBICIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN (AMIKACIN0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIME (CEFIPIME)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENCYCLANE FUMARATE (BENCYCLANE FUMARATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTRAN (DEXTRAN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527178-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0136</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ECURAL ^LIKE ELOCON^ TOPICALS</medicinalproduct>
        <drugauthorizationnumb>19543</drugauthorizationnumb>
        <drugdosagetext>10ML ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETILEFRINE ORAL SOLUTION</medicinalproduct>
        <drugdosagetext>2 ML (10 MG) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYPERICUM PERFORAMTUM (ST. JOHN'S  WORT) TABLETS</medicinalproduct>
        <drugdosagetext>50-60 TABLETS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041203</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527179-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004VX000928</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>12209</drugauthorizationnumb>
        <drugdosagetext>750 MG; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ADENOCARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527180-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210953</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527181-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210614</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.5</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>5 MG/KG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>3200 MG, 1/WEEK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>80 MG, 1/WEEK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBOFLAVIN TAB</medicinalproduct>
        <drugdosagetext>800 MG, 1/WEEK</drugdosagetext>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527182-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.9733</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>2 MG QOD 4 MG QOD</drugdosagetext>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527183-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103.8737</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugdosagetext>200 MG TID</drugdosagetext>
        <drugindication>HERPES SIMPLEX</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KCL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527184-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.0187</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAFCILLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527185-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MONTELUKAST</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527186-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.1324</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>150/300 MG BID</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDINAVIR</medicinalproduct>
        <drugdosagetext>800 MG Q 8 H</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527187-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.3273</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527188-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.7913</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG 2 TIME A DAY</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527189-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>12.5 - 25 MG</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527190-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-2004-035863</companynumb>
    <primarysource>
      <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 PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040828</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527191-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-2004-031412</companynumb>
    <primarysource>
      <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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D NEW AUTOINJECTOR, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN ^MERCK^ (METFORMIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527192-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2004-08082</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugdosagetext>125 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL (ACENOCOUMAROL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527193-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2004-07768</companynumb>
    <primarysource>
      <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>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG. BID,ORAL; 125 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG. BID,ORAL; 125 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANAESTHETICS, GENERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN(OXYGEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT (CALCIUM CARBONATE, CITRIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMEGEL (ALUMINIUM HYDROXIDE-MAGNESIUM CARBONATE GEL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAYEXALATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UMULINE (INSULIN HUMAN ZINC SUSPENSION)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE (ZOPICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527194-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2004-04330</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTREMITY NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FINGER AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOE AMPUTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG,BID,ORAL; 125 MG,BID,ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCLERODERMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG,BID,ORAL; 125 MG,BID,ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCLERODERMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORENTAL (PENTOXIFYLLINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FONZYLANE (BUFLOMEDIL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QVAR (BECLOMETASONE DIPROPIONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIASCLEDINE (PERSEAE OLEIUM, SOYA OIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527195-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2004-07487</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>5.2</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>16 MG,BID,ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITALIS CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERAPROST (BERAPROST)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL (SILDENAFIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527196-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2004-07079</companynumb>
    <primarysource>
      <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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</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>CARDIOPULMONARY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXACERBATED</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>20040624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527197-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>126.5536</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>15 MG P.O. DAILY IN AM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESKALITH CR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527198-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51.1</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRAIN CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO MENINGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 DAYS 1, 8, + 15 Q 28D</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 DAYS 1, 8, + 15 Q 28D</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 DAYS 1, 8, + 15 Q 28D</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 DAYS 1, 8, + 15 Q 28D</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 DAYS 1, 8, + 15 Q 28D</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 DAYS 1, 8, + 15 Q 28D</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 DAYS 1, 8, + 15 Q 28D</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 DAYS 1, 8, + 15 Q 28D</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 DAYS 1, 8, + 15 Q 28D</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 DAYS 1, 8, + 15 Q 28D</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 DAYS 1, 8, + 15 Q 28D</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 DAYS 1, 8, + 15 Q 28D</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 DAYS 1, 8, + 15 Q 28D</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 DAYS 1, 8, + 15 Q 28D</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 DAYS 1, 8, + 15 Q 28D</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 DAYS 1, 8, + 15 Q 28D</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 DAYS 1, 8, + 15 Q 28D</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 DAYS 1, 8, + 15 Q 28D</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 DAYS 1, 8, + 15 Q 28D</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 DAYS 1, 8, + 15 Q 28D</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 DAYS 1, 8, + 15 Q 28D</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 DAYS 1, 8, + 15 Q 28D</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 DAYS 1, 8, + 15 Q 28D</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 DAYS 1, 8, + 15 Q 28D</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 DAYS 1, 8, + 15 Q 28D</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 DAYS 1, 8, + 15 Q 28D</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527199-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.3795</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>15 MG P.O. DAILY WITH EVENING MEAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527200-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</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>THEOPHYLLINE EXTENDED RELEASE MFR: - PLIVA INC.</medicinalproduct>
        <drugbatchnumb>4833008PA</drugbatchnumb>
        <drugdosagetext>100 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527201-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CH15298</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTREMITY NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FINGER AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVEDO RETICULARIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugdosagetext>40 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527202-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP14747</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARCINOEMBRYONIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>45 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>90 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>90 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
        <drugtreatmentduration>95040</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527203-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004PL16435</companynumb>
    <primarysource>
      <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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527204-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004PL16436</companynumb>
    <primarysource>
      <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>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527205-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13117</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHLEBOTHROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugtreatmentduration>30240</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527206-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004PL16437</companynumb>
    <primarysource>
      <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>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527207-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12900</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>208</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
        <drugtreatmentduration>24480</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527208-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004PL16438</companynumb>
    <primarysource>
      <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>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527209-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004PL16439</companynumb>
    <primarysource>
      <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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>150 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527210-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004PL16440</companynumb>
    <primarysource>
      <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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>150 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527211-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004PL16443</companynumb>
    <primarysource>
      <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>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527212-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03124</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTANE</medicinalproduct>
        <drugdosagetext>15 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
        <drugtreatmentduration>101</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugdosagetext>4 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
        <drugtreatmentduration>14400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFLON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUCIDINE CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugdosagetext>400 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>122</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIXOL</medicinalproduct>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
        <drugtreatmentduration>101</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>2.5 G DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>127</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXAPAC</medicinalproduct>
        <drugdosagetext>300 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041009</drugenddate>
        <drugtreatmentduration>12960</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527213-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03632</companynumb>
    <primarysource>
      <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>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUTANEOUS LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527214-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04519</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATIONS, MIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugdosagetext>75MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPONDYLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>23040</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>20MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TILDIEM</medicinalproduct>
        <drugdosagetext>90 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>5MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugdosagetext>2.5MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527215-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004PL16247</companynumb>
    <primarysource>
      <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>ANOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESUSCITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMIPRAM TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PEPTIC ULCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527216-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03660</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugdosagetext>300 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEDICATION ERROR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527217-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004RU16337</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIACALCIC VS PLACEBO</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>FOREARM FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
        <drugtreatmentduration>179</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527218-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12894</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugdosagetext>200 IU, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugdosagetext>650 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527219-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16528</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPROMEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>50 TO 100 MG/DAY</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>SCIATICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527220-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP12940</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>30</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALPHA-2 MACROGLOBULIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BETA 2 MICROGLOBULIN URINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BETA-N-ACETYL-D-GLUCOSAMINIDASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY KIDNEY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALDOSTERONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHALAMO-PITUITARY DISORDERS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDO-BARTTER SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ELECTROPHORESIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>25 MG/DAY</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020810</drugenddate>
        <drugtreatmentduration>40320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030227</drugenddate>
        <drugtreatmentduration>2627</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAXATIVES</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYCYRRHIZINATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19941001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>25 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020607</drugenddate>
        <drugtreatmentduration>1753</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527221-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004TR16485</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEM</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>UNK, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527222-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004DE16824</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DUODENAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugindication>THROMBOPHLEBITIS SUPERFICIAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527223-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15854</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBLITERATIVE BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOMEDIASTINUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FK 506</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRRADIATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527224-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040907</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP11956</companynumb>
    <primarysource>
      <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>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040824</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040902</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PICIBANIL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040823</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PICIBANIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040902</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527225-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04495</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAMVIR</medicinalproduct>
        <drugdosagetext>750MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527226-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15901</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENGRAFTMENT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VP-16</medicinalproduct>
        <drugdosagetext>60 MG/KG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRRADIATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>L-ASPARAGINASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARA-C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugdosagetext>2 MG/KG/D</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527227-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004IT14283</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugdosagetext>8 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
        <drugtreatmentduration>93</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>200 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
        <drugtreatmentduration>93</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
        <drugtreatmentduration>93</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527228-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16520</companynumb>
    <primarysource>
      <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>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugindication>BONE MARROW TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527229-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004IT17251</companynumb>
    <primarysource>
      <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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSPLENISM ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>12.5 MG, QD</drugdosagetext>
        <drugindication>LUNG TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>275MG DAILY</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SDZ RAD</medicinalproduct>
        <drugdosagetext>1.5 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041204</drugenddate>
        <drugtreatmentduration>96480</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527230-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB03961</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COELIAC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527231-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CN16555</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040515</drugenddate>
        <drugtreatmentduration>33120</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETALOC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527232-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03604</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOPROL</medicinalproduct>
        <drugdosagetext>0.5 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIATUS HERNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSANXIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527233-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041201509</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVENTRICULAR SEPTUM RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; ABCIXIMA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED; ABCIXIMA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEPIRUDIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERBUTALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527235-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13190</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EAR INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527236-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugbatchnumb>IT402GN</drugbatchnumb>
        <drugdosagetext>2 TSP TWICE DAILY</drugdosagetext>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLORINEF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527238-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98.8842</patientweight>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugdosagetext>400 MG EVERY DAY</drugdosagetext>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527239-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.7913</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugdosagetext>X2/DAY EVERY 12 HRS</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BABY ASPRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527240-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STUPOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527242-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 WKLY V</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 WKLY V</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 WKLY V</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 WKLY V</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 WKLY V</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 WKLY V</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 WKLY V</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 WKLY V</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 WKLY V</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 WKLY V</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 WKLY V</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 WKLY V</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 WKLY V</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 WKLY V</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 WKLY V</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 WKLY V</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 WKLY V</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 WKLY V</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 WKLY V</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 WKLY V</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 WKLY V</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 WKLY V</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 WKLY V</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 WKLY V</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 WKLY V</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>90 MG/M2 WKLY V</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527243-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.2554</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AEROBID</medicinalproduct>
        <drugbatchnumb>553651-00</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AEROBID</medicinalproduct>
        <drugbatchnumb>553651-00</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AEROBID</medicinalproduct>
        <drugbatchnumb>553651-00</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>VOCAL CORD DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527244-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25 MG PER DAY ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527245-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43.0917</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE STOOLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>5 MG ONCE A DAY</drugdosagetext>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527246-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELAYED RECOVERY FROM ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEPTOCAINE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527247-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.1011</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL FLUCTUATING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>VARYING DOSE DAILY BY MOUTH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>VARYING DOSE DAILY BY MOUTH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527248-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAM STAIN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOMEDIASTINUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN</medicinalproduct>
        <drugdosagetext>165MG/M2  96 HRS CON   INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFLAMMATORY CARCINOMA OF THE BREAST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>100MG/KG  ONCE ????  INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527249-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.5338</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>25 MG Q6 ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527250-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.5338</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>10 MG AC AND H.S.</drugdosagetext>
        <drugindication>IMPAIRED GASTRIC EMPTYING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>10 MG AC AND H.S.</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041209</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527251-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS CHOLESTATIC</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>PO HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527252-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101.6057</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugdosagetext>0.85MG IVCI QD</drugdosagetext>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>400 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527253-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.4619</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
        <drugdosagetext>ONCE BID</drugdosagetext>
        <drugindication>ESSENTIAL TREMOR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527254-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugdosagetext>50 MG/M2</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>35 MG/M2</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>35 MG/M2</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527256-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>1500 MG</drugdosagetext>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AQUAPHOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>A+D OINTMENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527257-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04493</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERBINAFINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>61920</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527259-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04488</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSIVE SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERBINAFINE HCL</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527262-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527264-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>1 TAB DAILY</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>1 TAB DAILY</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527266-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXCARBAZEPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527269-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.5234</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugbatchnumb>5517</drugbatchnumb>
        <drugdosagetext>1 TAB DAILY</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PONDIMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYLERT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </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>FLONASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527270-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.3284</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>100 MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527271-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527272-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL   50 QD</medicinalproduct>
        <drugdosagetext>50 QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527283-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20041201043</companynumb>
    <primarysource>
      <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>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>19 INFUSIONS HAVE BEEN ADMINISTERED.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527284-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041201392</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.33</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</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>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIAPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SMZ-TMP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SMZ-TMP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527285-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041201396</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>38.56</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527286-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041201449</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINE CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527287-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041201453</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527288-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20041201625</companynumb>
    <primarysource>
      <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>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</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>KETOPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527289-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041201869</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</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>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOSUPPRESSIVES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOMODULATORS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527291-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NSADSS2002029109</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527292-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040809891</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.04</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03H041A;03K133A;04A042A;04B154A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03H041A;03K133A;04A042A;04B154A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03H041A;03K133A;04A042A;04B154A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03H041A;03K133A;04A042A;04B154A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03H041A;03K133A;04A042A;04B154A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03H041A;03K133A;04A042A;04B154A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03H041A;03K133A;04A042A;04B154A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASERETIC</medicinalproduct>
        <drugdosagetext>EVERY DAY.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASERETIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASERETIC</medicinalproduct>
        <drugdosagetext>EVERY DAY.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>VARRIED WITH 7.5 MG PER WEEK</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>VARRIED WITH 10 MG PER WEEK</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OGEN</medicinalproduct>
        <drugdosagetext>1/2</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527294-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041106199</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA FUNGAL</reactionmeddrapt>
      </reaction>
      <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>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVER</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYDOXAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA-N</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527295-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041200195</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527296-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20040105857</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXANTHEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>TUBERCULOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXAL</medicinalproduct>
        <drugbatchnumb>1L102A;2E031A;2032A</drugbatchnumb>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugindication>TUBERCULOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPHENIRAMINE MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527297-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041104123</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>183.25</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER STAGE IV WITH METASTASES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SARCOIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>02G024A;03K013A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UVEITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRED FORTE</medicinalproduct>
        <drugindication>INFLAMMATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527298-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040103208</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.97</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527303-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugbatchnumb>U6514</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527307-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527309-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugdosagetext>10 MG BEFORE MEALS</drugdosagetext>
        <drugindication>IMPAIRED GASTRIC EMPTYING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugdosagetext>10 MG BEFORE MEALS</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugdosagetext>25 MG  EVERY 6HRS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527312-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></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>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugdosagetext>150 MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugdosagetext>150 MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FATIGUE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527314-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC OUTLET OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>1.86 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHOP(CYCLOPHOSPHAMIDE,DOXORUBICIN,VINCRISTINE,PREDNISONE)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527317-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>31.7518</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL XR 20</medicinalproduct>
        <drugdosagetext>ONCE DAILY</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugdosagetext>ONCE DAILY</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040618</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527319-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.6683</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BCNU</medicinalproduct>
        <drugdosagetext>80 MG/M2  DAY 1-3, 56-58 , INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ASTROCYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBATROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527322-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>34.927</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE ER</medicinalproduct>
        <drugdosagetext>1  2X DAILY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADDERALL XR 20</medicinalproduct>
        <drugdosagetext>1 1X DAILY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527324-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108.8633</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPTH DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>ONCE DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>ONCE DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>ONCE DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>ONCE DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527326-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.7913</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527329-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>105.6881</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>6MG  DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEEP VENOUS THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>6MG  DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>KNEE ARTHROPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOROLAC</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCELEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527330-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>30  MG 1 X A DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>1.5 MG  2X A DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041213</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527331-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.586</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>20 MG/M2  DAILY X 5 INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040903</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>15 MG/M2  DAILY X 5 INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040903</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527333-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>175MG/M2  DAY 1 EVERY 21  INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>800MG/M2  DAY1,8 EVERY21  INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527334-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>AUC=5</drugdosagetext>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527336-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94.8018</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>2000MG  BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040903</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527337-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.6788</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>3MG  DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527338-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ABBOTT-04P-144-0280428-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTERAL NUTRITION</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527339-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.1324</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>20 MG/M2  DAILY X 5 INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>15 MG/M2  DAILY X 5 INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527340-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4316</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>PO ONCE DAILY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527341-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAQUINE PHOSPHATE</medicinalproduct>
        <drugbatchnumb>P12657</drugbatchnumb>
        <drugdosagetext>30 MG BASE  Q DAY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOROQUINE PHOSPHATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527342-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.8852</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugbatchnumb>3H2262</drugbatchnumb>
        <drugdosagetext>24 MCG  KG/HR X 96 HOUR</drugdosagetext>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527343-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>1 TABLET DAILY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527344-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84.369</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>ONE TABLET  PER DAY  BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040828</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527345-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.6376</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN  CAPECITABINE 750MG/M^2  DAY 1THROUGH 14</medicinalproduct>
        <drugdosagetext>130MG/M^2  DAY 1 INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>1.00 MG/M^2  DAY 1 AND 8 INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527347-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMERGE</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527348-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.4212</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>1 CAPSULE  DAY RESPIRATORY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527349-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugdosagetext>100MG PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527350-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPRELVEKIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527351-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>37.195</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>281.25 MG</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041206</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>444.2 MG</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041206</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527354-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAQUINE PHOSPHATE</medicinalproduct>
        <drugbatchnumb>P12657</drugbatchnumb>
        <drugdosagetext>30 MG   Q DAY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOROQUINE PHOSPHATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527356-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAQUINE PHOSPHATE</medicinalproduct>
        <drugbatchnumb>P12657</drugbatchnumb>
        <drugdosagetext>30 MG BASE   QD   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOROQUINE PHOSPHATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527359-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAQUINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>15 MG   Q DAY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041205</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527361-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.2554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527363-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD METHAEMOGLOBIN PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETACAINE SPRAY              CETYLITE INDUSTRIES</medicinalproduct>
        <drugdosagetext>1-2 SPRAYS   ONCE   OROPHARING</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ECHOCARDIOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527365-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12783445</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040827</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527366-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12784252</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>START DATE:  27-SEP-2004.  80 - 100 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN-XR</medicinalproduct>
        <drugdosagetext>STARTED PRIOR TO INFORMED CONSENT.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>STARTED PRIOR TO INFORMED CONSENT.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSTAN</medicinalproduct>
        <drugdosagetext>STARTED PRIOR TO INFORMED CONSENT.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANDSEN</medicinalproduct>
        <drugdosagetext>STARTED PRIOR TO INFORMED CONSENT.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEXITIL</medicinalproduct>
        <drugdosagetext>STARTED PRIOR TO INFORMED CONSENT.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>STARTED PRIOR TO INFORMED CONSENT.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNIDE</medicinalproduct>
        <drugdosagetext>STARTED PRIOR TO INFORMED CONSENT.  12 - 24 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON</medicinalproduct>
        <drugdosagetext>STARTED PRIOR TO INFORMED CONSENT.  ^OPTIMUM^</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEO-MINOPHAGEN C</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527367-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12793394</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527373-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-0634</companynumb>
    <primarysource>
      <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>CHORIOAMNIONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNDACTYLY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527379-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12794061</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527380-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-09-1283</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527391-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041201143</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHORIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BURINEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527392-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041103759</companynumb>
    <primarysource>
      <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>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY ASPHYXIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527393-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041202089</companynumb>
    <primarysource>
      <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>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANDOSPIRONE CITRATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIANSERIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>TUMOUR ASSOCIATED FEVER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>ROUTE: PARENTAL</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>ROUTE: ORAL</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>ROUTE: PARENTAL</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM PICOSULFATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETAMINE HCL</medicinalproduct>
        <drugdosagetext>60-200 MG/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugdosagetext>6-20 MG/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugdosagetext>0-2 DOSAGE FORM/DAY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527400-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12792388</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>ENDOMETRIAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugindication>ENDOMETRIAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>ENDOMETRIAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527402-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12788667</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>1ST DOSE 14-SEPT-04,WEEKLY FOR 17 WEEKS.LAST GIVEN 23-NOV-04 DOSE 461 MG-RECEIVED 8 DOSES.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>1ST ON 14-SEPT-04,GIVEN AUC=2,WEEKLY FOR 7 WKS,THEN AUC=6 EVERY 3 WKS TWICE.LAST 26-OCT(221MG),HELD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>1ST ON 14-SEPT-04,WEEKLY FOR 7 WKS,THEN 200MG/M2 EVERY 3 WKS TWICE.LAST 26-OCT(85MG).THERAPY HELD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527424-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12789004</companynumb>
    <primarysource>
      <qualification>5</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>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527437-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200418952US</companynumb>
    <primarysource>
      <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>ACCOMMODATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMBLYOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGRAPHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>READING DISORDER</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>KETEK</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527441-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419475US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527442-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413499JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.1</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL</medicinalproduct>
        <drugdosagetext>DOSE: 2 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>DOSE: 2 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLITOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANOREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TATHION</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROHEPARUM</medicinalproduct>
        <drugdosagetext>DOSE: 6 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC FUNCTION ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROVITAN</medicinalproduct>
        <drugdosagetext>DOSE: 3 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC FUNCTION ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOLAMIN 3B INJ.</medicinalproduct>
        <drugdosagetext>DOSE: 1 A</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERPERAN</medicinalproduct>
        <drugindication>ANOREXIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527443-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421943GDDC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugdosagetext>DOSE: 1 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527444-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414619FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE-DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION ENTEROCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAFORAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIKLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>DOSE: 2-2-2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
        <drugindication>SEPTIC SHOCK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugindication>SEPTIC SHOCK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040522</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527445-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414621FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GRANULOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYOSTACINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DI-ANTALVIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYAMBUTOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANSATIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527446-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421959GDDC</companynumb>
    <primarysource>
      <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINIRIN ^FERRING^</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES INSIPIDUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugbatchnumb>UN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLIMASTON</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIPINE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527447-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419416US</companynumb>
    <primarysource>
      <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>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527448-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419444US</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 20-22 ; DOSE UNIT: UNITS</drugdosagetext>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527449-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419445US</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527450-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419450US</companynumb>
    <primarysource>
      <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>APPENDICECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527451-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419083US</companynumb>
    <primarysource>
      <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>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANZEMET</medicinalproduct>
        <drugbatchnumb>A4188</drugbatchnumb>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL /OLD FORM/</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527452-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040812</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200412542EU</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527453-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200418298US</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 40-45; DOSE UNIT: UNITS</drugdosagetext>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIOVASCULAR SYSTEM DRUGS</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527454-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421852GDDC</companynumb>
    <primarysource>
      <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 SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030310</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527455-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041203008</companynumb>
    <primarysource>
      <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>CEREBRAL ARTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS CEREBRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527472-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020521</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2002PL03965</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARBOHYDRATE ANTIGEN 125 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSFUNCTIONAL UTERINE BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>25 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>7.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAD</medicinalproduct>
        <drugdosagetext>3 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>75 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527489-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12789491</companynumb>
    <primarysource>
      <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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUNGIZONE</medicinalproduct>
        <drugdosagetext>10 MG PER DAY 15- TO 16-NOV-2004, THEN DOSAGE INCREASED TO 20 MG FROM 17- TO 24-NOV-2004</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>SYSTEMIC MYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527490-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030305</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-NOVOPROD-225477</companynumb>
    <primarysource>
      <qualification>3</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>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVONORM</medicinalproduct>
        <drugdosagetext>1-1.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030103</drugenddate>
        <drugtreatmentduration>34560</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DACORTIN</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021226</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DACORTIN</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021230</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DACORTIN</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021231</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030202</drugenddate>
        <drugtreatmentduration>47520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALIDUR</medicinalproduct>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021231</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030202</drugenddate>
        <drugtreatmentduration>47520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527491-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2003US01124</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBARIC OXYGEN THERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANDIBULECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>Q28 DAYS</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020507</drugenddate>
        <drugtreatmentduration>426</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugindication>CHRONIC SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010222</drugenddate>
        <drugtreatmentduration>358</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANASTROZOLE</medicinalproduct>
        <drugdosagetext>1 UNK, QD</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030211</drugenddate>
        <drugtreatmentduration>720</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>2 PUFFS, PRN</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527493-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12788188</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLATINOL-AQ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527496-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12790614</companynumb>
    <primarysource>
      <qualification>1</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>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRIPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040506</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASTET</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040508</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527500-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421923GDDC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527501-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414648FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPT-A-MYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527502-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410205JP</companynumb>
    <primarysource>
      <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>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED IMMUNE RESPONSIVENESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRIDOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFELAT L</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIO THREE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STOMACH DISCOMFORT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KIPRES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUVENYL</medicinalproduct>
        <drugdosagetext>ROUTE: INTRAARTICULAR, INTRASYNOVIAL</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFELAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527503-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200411894JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMATIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527504-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410303JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</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>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFUSE ALVEOLAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CONSOLIDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS EROSIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KOLANTYL GEL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCTIVE COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040208</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527505-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413626FR</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRRHOSIS ALCOHOLIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC TRAUMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFU K</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527520-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004PL16421</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>400 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527550-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040920</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12793766</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>TOTAL DOSE: 7200 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>TOTAL DOSE: 1600 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>TOTAL DOSE: 1600 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOSPORIN G.U.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527551-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040920</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12794368</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>TOTAL DOSE: 7200 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>TOTAL DOSE: 1600 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>TOTAL DOSE: 1600 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA-2B</medicinalproduct>
        <drugdosagetext>INITIATED 1 X10^6/M2; INCR'D TO 2 X10^6/M2 AFTER 1 MO; FINAL DOSE 3 X10^6/M2 AFTER 2ND MO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOSPORIN G.U.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM-SULFAMETHOXAZOLE</medicinalproduct>
        <drugdosagetext>1 DOUBLE-STRENGTH TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527552-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040920</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12794350</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF BONE MARROW TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>TOTAL DOSE: 7200 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>TOTAL DOSE: 1600 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>TOTAL DOSE: 1600 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA-2B</medicinalproduct>
        <drugdosagetext>INITIATED 1 X10^6/M2; INCR'D TO 2 X10^6/M2 AFTER 1 MO; FINAL DOSE 3 X10^6/M2 AFTER 2ND MO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOSPORIN G.U.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM-SULFAMETHOXAZOLE</medicinalproduct>
        <drugdosagetext>1 DOUBLE-STRENGTH TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527554-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040920</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12794376</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>TOTAL DOSE: 7200 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>TOTAL DOSE: 1600 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>TOTAL DOSE: 1600 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOSPORIN G.U.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527565-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE04132</companynumb>
    <primarysource>
      <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>LICHEN PLANUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN-SR</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527582-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2003CA00554</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GESTATIONAL DIABETES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
        <drugindication>HYPERGLYCAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugindication>HYPERGLYCAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527586-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CA16446</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>80 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527587-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004ES16597</companynumb>
    <primarysource>
      <qualification>3</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>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040521</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040521</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040521</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040521</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040521</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040521</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRA</medicinalproduct>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040523</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527588-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15895</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SUPPLEMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRAN</medicinalproduct>
        <drugdosagetext>75 UG/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>FULL BLOOD COUNT DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRAN</medicinalproduct>
        <drugdosagetext>150 UG/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
        <drugtreatmentduration>24480</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMERIN</medicinalproduct>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040805</drugenddate>
        <drugtreatmentduration>33120</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugdosagetext>20 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>95</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>3 DF/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>82</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOID</medicinalproduct>
        <drugdosagetext>60 ML/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>95</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugdosagetext>750 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugdosagetext>300 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040729</drugenddate>
        <drugtreatmentduration>23040</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugdosagetext>20 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
        <drugtreatmentduration>40320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>31680</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527589-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16456</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANTS</medicinalproduct>
        <drugdosagetext>^LOTS^</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041205</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>14 DF, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041205</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527596-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16559</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041128</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOOD COAGULATION FACTORS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527597-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US11191</companynumb>
    <primarysource>
      <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>BONE INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527599-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04499</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>500MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugdosagetext>75MG/DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527602-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004FR17253</companynumb>
    <primarysource>
      <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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
        <drugtreatmentduration>381</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527613-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2004AU01714</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>FROM ? TO 250-300 MG, DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>100 MG, DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527632-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US102032</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527633-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-US099399</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC LYMPHOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527635-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE173203NOV04</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULAR PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>NOT SPECIFIED</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
        <drugtreatmentduration>1168</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLATE LYSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527636-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE230524NOV04</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527637-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US101847</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA ELEVATUM DIUTINUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HILUM MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527639-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12791760</companynumb>
    <primarysource>
      <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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527640-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12785895</companynumb>
    <primarysource>
      <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>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527641-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040520</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12592119</companynumb>
    <primarysource>
      <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 CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020318</drugenddate>
        <drugtreatmentduration>1648</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020505</drugenddate>
        <drugtreatmentduration>868</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020608</drugenddate>
        <drugtreatmentduration>2370</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981215</drugenddate>
        <drugtreatmentduration>490</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527642-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12789517</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</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>
        <drugdosagetext>INITIATED ON 04-NOV-2004(LD=688MG), 4 COURSES REC'D TO DATE. TOTAL DOSE ADMIN. THIS COURSE=418MG.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>INITIATED ON 09-NOV-2004. 4 DOSES TO DATE. DELAYED 7 DAYS. TOTAL DOSE ADMIN THIS COURSE=50MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugdosagetext>THERAPY INITAITED ON 09-NOV-2004. EXTERNAL BEAM NOS. TOTAL DOSE (TO DATE): 34 GY.</drugdosagetext>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041203</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIFOSTINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527643-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040823</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE994823AUG04</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040715</drugenddate>
        <drugtreatmentduration>427</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040715</drugenddate>
        <drugtreatmentduration>674</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527645-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US097729</companynumb>
    <primarysource>
      <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>CUTANEOUS VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527646-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US102908</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOPERITONEUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527647-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030418</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US035892</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYASTHENIA GRAVIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527650-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE259906DEC04</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527651-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040820</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE992920AUG04</companynumb>
    <primarysource>
      <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>BETA 2 MICROGLOBULIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>T-CELL LYMPHOMA STAGE IV</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040115</drugenddate>
        <drugtreatmentduration>215</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>10 MG (UNSPECIFIED INTERVAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010615</drugenddate>
        <drugtreatmentduration>92</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>0.3 G EVERY 1 CYC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030515</drugenddate>
        <drugtreatmentduration>578</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030515</drugenddate>
        <drugtreatmentduration>670</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527652-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE195511NOV04</companynumb>
    <primarysource>
      <qualification>3</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>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527653-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-US103103</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>SPONDYLOARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527654-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE244030NOV04</companynumb>
    <primarysource>
      <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>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL SUPPLEMENT SUPPLEMENT NOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527655-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US096423</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DNA ANTIBODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527656-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535647A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DIATHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PIGMENTATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ECOTRIN ADULT LOW STRENGTH TABLETS</medicinalproduct>
        <drugbatchnumb>4E24</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOVITAMINOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527657-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535662A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTERNATIVE THERAPY</medicinalproduct>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL MEDICINE</medicinalproduct>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527658-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535794A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLONIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITRUCEL CLEAR MIX</medicinalproduct>
        <drugbatchnumb>04G238</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIVERTICULUM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENEFIBER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAX SEED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527659-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535963A</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE (MINT)</medicinalproduct>
        <drugbatchnumb>FE516</drugbatchnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-THYROXINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527660-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE265108DEC04</companynumb>
    <primarysource>
      <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>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527664-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SOLVAY-00204003917</companynumb>
    <primarysource>
      <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHROMAGEN FORTE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETRIUM</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 200 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSFUNCTIONAL UTERINE BLEEDING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>DAILY DOSE: .075 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527669-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00068</companynumb>
    <primarysource>
      <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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL TEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VASCULAR THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527676-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0410GBR00173</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527678-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0412USA01118</companynumb>
    <primarysource>
      <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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RILMAZAFONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRORENAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527679-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20010927</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-01093165</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL DEFORMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527680-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA01090</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUTTOCK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527681-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA01571</companynumb>
    <primarysource>
      <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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010906</drugenddate>
        <drugtreatmentduration>214</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010906</drugenddate>
        <drugtreatmentduration>214</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020308</drugenddate>
        <drugtreatmentduration>1094</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATLEP</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020308</drugenddate>
        <drugtreatmentduration>1094</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020308</drugenddate>
        <drugtreatmentduration>1094</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527682-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA02728</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527683-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00031</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527684-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0409USA01831</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527685-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA01843</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>127</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COSTOCHONDRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</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>SEREVENT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527686-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00104</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>123</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLECALCIFEROL AND CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527687-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0411AUS00228</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527688-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-MERCK-0412NOR00018</companynumb>
    <primarysource>
      <qualification>3</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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE AND IRBESARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527689-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA02164</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527691-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-MERCK-0412BEL00013</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527692-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0412AUS00050</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[COMPOSITION UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[COMPOSITION UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIATUS HERNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[COMPOSITION UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RELAXATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527693-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA04208</companynumb>
    <primarysource>
      <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>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSMEGEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIRARUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527697-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE202415NOV04</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECHINOCOCCIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527698-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12508032</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO KIDNEY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>THERAPY INITIATED 04 FEB 2004. 458 MG ADMINISTERED ON 26-FEB-2004.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugdosagetext>SUBSEQUENT DOSE 572 MG ADMINISTERED ON 26-FEB-2004 (LAST DOSE).</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040204</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>600MG DAILY UNTIL 12-FEB-03,1800MG/DAY 13-18 FEB,600MG/DAY FROM 19-FEB-04</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040318</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031021</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527700-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12783114</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FOCAL NODULAR HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICES OESOPHAGEAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX EC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021115</drugenddate>
        <drugtreatmentduration>1881</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021115</drugenddate>
        <drugtreatmentduration>1881</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGENERASE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030130</drugenddate>
        <drugtreatmentduration>1572</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527701-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12792727</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020201</drugenddate>
        <drugtreatmentduration>763</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUSCLE RELAXANT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISULFIRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE + ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527704-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12789046</companynumb>
    <primarysource>
      <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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPH NODE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFEX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARCINOMA</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARCINOMA</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARCINOMA</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>AUC 5; DAY 2 ONLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527736-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ROCHE-384478</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>GIVEN IN TWO DOSES OF 2000 MG AND 2150 MG DAILY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040912</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527737-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-388730</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DICLAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CALCIPRAT</medicinalproduct>
        <drugdosagetext>GENERIC CALCIUM CARBONATE/CALCIFEROL.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>AEQUAMEN</medicinalproduct>
        <drugdosagetext>SECONDARY INDICATION VERTIGO.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TINNITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOT KNOWN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040715</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527738-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-388401</companynumb>
    <primarysource>
      <qualification>5</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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugdosagetext>FORMULATION REPORTED AS INJECTABLE SOLUTION.</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040906</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SECTRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTAREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527739-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-383688</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCLERODERMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040531</drugenddate>
        <drugtreatmentduration>145</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDIATOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELISOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527740-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-385799</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031031</drugenddate>
        <drugtreatmentduration>106</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040123</drugenddate>
        <drugtreatmentduration>298</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040123</drugenddate>
        <drugtreatmentduration>298</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE-ALPHA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040123</drugenddate>
        <drugtreatmentduration>206</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTELUC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040123</drugenddate>
        <drugtreatmentduration>199</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527741-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ROCHE-384478</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>GIVEN IN TWO DOSES OF 2000 MG AND 2150 MG DAILY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040912</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527742-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ROCHE-388314</companynumb>
    <primarysource>
      <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>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOLERANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC HEPATITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC HEPATITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527743-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ROCHE-388957</companynumb>
    <primarysource>
      <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>OPPORTUNISTIC INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIMOXAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527744-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-389026</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDENE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527770-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0532405A</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527771-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0535050A</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUFFOCATION FEELING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>B134616</drugbatchnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041204</drugenddate>
        <drugtreatmentduration>930</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041204</drugenddate>
        <drugtreatmentduration>930</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugdosagetext>40MG AT NIGHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
        <drugtreatmentduration>926</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERPHENAZINE</medicinalproduct>
        <drugdosagetext>4MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
        <drugtreatmentduration>892</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>.6MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
        <drugtreatmentduration>919</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527775-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536572A</companynumb>
    <primarysource>
      <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>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugbatchnumb>B131623</drugbatchnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENAPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527776-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536678A</companynumb>
    <primarysource>
      <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>FOETAL GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITALIA EXTERNAL AMBIGUOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugdosagetext>1250MG TWICE PER DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527777-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536768A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527778-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536873A</companynumb>
    <primarysource>
      <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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527779-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536927A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POSTMENOPAUSAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040518</drugstartdate>
        <drugtreatmentduration>177</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527780-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537119A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527781-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537120A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527782-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040722</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0340350A</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
        <drugdosagetext>2500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugdosagetext>.2MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INADEQUATE CONTROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
        <drugtreatmentduration>245</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527783-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0344295A</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
        <drugtreatmentduration>866</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPROMEL</medicinalproduct>
        <drugdosagetext>25MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
        <drugtreatmentduration>883</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUVOX</medicinalproduct>
        <drugdosagetext>3U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTAN</medicinalproduct>
        <drugdosagetext>6MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
        <drugtreatmentduration>770</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLADDERON</medicinalproduct>
        <drugdosagetext>3U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
        <drugtreatmentduration>883</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAZATICOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>3U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
        <drugtreatmentduration>778</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>3U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTESTINAL HYPOMOTILITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
        <drugtreatmentduration>719</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFERTILITY THERAPY UNSPECIFIED</medicinalproduct>
        <drugdosagetext>6G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
        <drugtreatmentduration>875</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TINELAC</medicinalproduct>
        <drugdosagetext>2U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
        <drugtreatmentduration>883</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOODMIN</medicinalproduct>
        <drugdosagetext>.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
        <drugtreatmentduration>831</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALMATE</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
        <drugtreatmentduration>883</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527784-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040909</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GLAXOSMITHKLINE-B0345343A</companynumb>
    <primarysource>
      <qualification>5</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>MALARONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527785-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040909</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GLAXOSMITHKLINE-B0345343B</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL MALFORMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MALARONE PEDIATRIC</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527786-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>12692190</companynumb>
    <primarysource>
      <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>BLOOD AMYLASE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040325</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040325</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040325</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527787-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0349717A</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOGORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527795-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0349722A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLUMSINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEREALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041010</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527796-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0357455A</companynumb>
    <primarysource>
      <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>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040905</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
        <drugdosagetext>16MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040905</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527797-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0357482A</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>2TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEFENAMIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHEMOPHILIC FACTOR (HUMAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527798-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0358647A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIET REFUSAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOLILOQUY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROHYPNOL</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527799-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0358933A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040212</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040326</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUCIDINE CAP</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040109</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040330</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>3UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFUROXIM</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NECYRANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICLOTYMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBROXOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
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    <safetyreportid>4527800-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-GLAXOSMITHKLINE-B0361120A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </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>RENAL FAILURE CHRONIC</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
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  <safetyreport>
    <safetyreportid>4527806-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
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    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041201303</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EQUANIL</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>ZESTRIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
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      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>4527808-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-JNJFOC-20041201306</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </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>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>REACTIVE PSYCHOSIS</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXASCAND</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEMINEVRIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELOKEN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
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        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
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      <drug>
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        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPIKLON</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4527809-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20041006997</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <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>RISPERDAL CONSTA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZUCLOPENTIXOL</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040220</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDENO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031112</drugstartdate>
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  <safetyreport>
    <safetyreportid>4527819-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041202545</companynumb>
    <primarysource>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
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      <drug>
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        <medicinalproduct>LAMICTAL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
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    <safetyreportid>4527821-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
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    <receivedateformat>102</receivedateformat>
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    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20041202809</companynumb>
    <primarysource>
      <qualification>2</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE</medicinalproduct>
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  <safetyreport>
    <safetyreportid>4527822-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040902881</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040823</drugenddate>
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      <drug>
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        <medicinalproduct>IRON SUPPLEMENT</medicinalproduct>
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      <drug>
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        <medicinalproduct>COUMADIN</medicinalproduct>
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      <drug>
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        <medicinalproduct>COUMADIN</medicinalproduct>
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        <medicinalproduct>LASIX</medicinalproduct>
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        <medicinalproduct>ATIVAN</medicinalproduct>
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      <drug>
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        <medicinalproduct>NEXIUM</medicinalproduct>
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        <medicinalproduct>ARICEPT</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
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    <safetyreportid>4527823-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
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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>ERECTILE DYSFUNCTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
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    <safetyreportid>4527825-6</safetyreportid>
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    <receivedateformat>102</receivedateformat>
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    <companynumb>200420567BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
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        <reactionmeddrapt>SEMEN DISCOLOURATION</reactionmeddrapt>
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      <drug>
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        <drugindication>ERECTILE DYSFUNCTION</drugindication>
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      <drug>
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        <medicinalproduct>ZETIA</medicinalproduct>
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        <medicinalproduct>ACTOS</medicinalproduct>
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        <medicinalproduct>ALTACE</medicinalproduct>
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      <drug>
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        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
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    <safetyreportid>4527827-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
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    <primarysource></primarysource>
    <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>
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        <medicinalproduct>LEVITRA</medicinalproduct>
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        <drugindication>DRUG EFFECT PROLONGED</drugindication>
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        <drugstartdate>20040913</drugstartdate>
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    <safetyreportid>4527830-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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      <qualification>4</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
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      <patientonsetageunit>801</patientonsetageunit>
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        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugindication>PREMATURE MENOPAUSE</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>PREMATURE MENOPAUSE</drugindication>
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        <drugstartdate>19940101</drugstartdate>
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        <drugindication>PREMATURE MENOPAUSE</drugindication>
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        <drugstartdate>19940101</drugstartdate>
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    <safetyreportid>4527832-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12794640</companynumb>
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      <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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYSODREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADRENAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527833-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LB-BRISTOL-MYERS SQUIBB COMPANY-12785218</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROVEL TABS 150 MG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040511</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527834-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12794749</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ADRENOCORTICAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYSODREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADRENOCORTICAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030429</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METYRAPONE</medicinalproduct>
        <drugindication>ADRENOCORTICAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030429</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDROCORTISONE ACETATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527841-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420573BWH</companynumb>
    <primarysource></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>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, OW, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527843-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420574BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527845-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420575BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXB9161</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527848-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420579BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.4514</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXBAK71</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, PRN, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXBAK71</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, PRN, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVENTATIVE FOR HIGH CHOLESTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527851-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420584BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>122.4712</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE REDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXBCLC1</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527854-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420586BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTION INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527856-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420590BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527860-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420465BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTION INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527861-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040903</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420471BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>BIW, ORAL;  30 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040903</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>BIW, ORAL;  30 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527863-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040904</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420473BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EJACULATION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527866-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420474BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527869-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420479BWH</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>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527871-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420482BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527873-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12718706</companynumb>
    <primarysource>
      <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>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIXIVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527875-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420499BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.7913</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENTERMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROSTAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527877-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420500BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>15 MG, TIW, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD THINNER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527879-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420517BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527900-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04497</companynumb>
    <primarysource>
      <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>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC POTASSIUM</medicinalproduct>
        <drugdosagetext>50MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
        <drugdosagetext>10 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527915-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12790598</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRIPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010213</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASTET</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010215</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527916-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12794723</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYSODREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADRENAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030606</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527917-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-12786778</companynumb>
    <primarysource>
      <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>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugdosagetext>INTERRUPTED 07-DEC-2004</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugdosagetext>ONCE DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM + SULFAMETHOXAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4527932-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12788873</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <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>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UTERINE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>THERAPY FROM 07-OCT-2004 TO 21-OCT-2004 (3 DAYS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UTERINE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528012-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-04P-062-0279680-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALLORY-WEISS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS LISTERIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
        <drugtreatmentduration>128</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528015-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030604</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ABBOTT-03P-114-0220667-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS NEUROSENSORY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030604</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030529</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528017-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-04P-062-0282775-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOPTIN RR PLUS, RETARDKAPSELN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOPTIN RR PLUS, RETARDKAPSELN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528018-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-ABBOTT-04P-007-0264231-01</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>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
        <drugtreatmentduration>272</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPRANAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRIMETAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
        <drugtreatmentduration>213</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFADIAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
        <drugtreatmentduration>213</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
        <drugtreatmentduration>213</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRUM</medicinalproduct>
        <drugdosagetext>7.5/300 MG</drugdosagetext>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
        <drugtreatmentduration>55</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528019-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0282843-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</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>DESMOPRESSIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APOREX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528021-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0282551-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</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>INDOMETHACIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528022-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0282919-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.02</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FRACTURE</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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528023-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0282648-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE W/LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528024-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ABBOTT-04P-114-0278088-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC</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>LAMOTRIGINE</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMMERCIAL HUMIRA</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528025-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-04P-062-0282084-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOCORTICOIDS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED NSAID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528141-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-MERCK-0412ZAF00006</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVANZ</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRAZOLAM MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528143-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA01687</companynumb>
    <primarysource>
      <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>LUMBAR VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021127</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARNAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVAMIN (PROCHLORPERAZINE MESYLATE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031220</drugenddate>
        <drugtreatmentduration>1005</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC EFFECT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031220</drugenddate>
        <drugtreatmentduration>1005</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031220</drugenddate>
        <drugtreatmentduration>1005</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031220</drugenddate>
        <drugtreatmentduration>1005</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528144-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01548</companynumb>
    <primarysource>
      <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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAVIK</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528146-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0207USA01010</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </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>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC EFFECT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYCOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528150-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA04065</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>2329</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENIVACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITOROL-R</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASLON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHIMAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCYRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOVITAMINOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN-S</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528151-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040225</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0402FRA00086</companynumb>
    <primarysource>
      <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>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFIBRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICERGOLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>CATARACT OPERATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528153-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0412FRA00038</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528154-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020910</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0209USA01001</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICOBRACHIAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDUCTION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULAR PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYCYTHAEMIA VERA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000224</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528155-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0412USA01387</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTINEOPLASTIC (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528158-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00115</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>778</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>778</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THYROIDECTOMY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENSERAZIDE HYDROCHLORIDE AND LEVODOPA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528159-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0412FRA00043</companynumb>
    <primarysource>
      <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>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DANAPAROID SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THROMBOPHLEBITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>THROMBOPHLEBITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528160-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-MERCK-0411SWE00041</companynumb>
    <primarysource>
      <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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA AND LEVODOPA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETILEFRINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE DIHYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENSERAZIDE HYDROCHLORIDE AND LEVODOPA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528162-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03763</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528164-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040312</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0403USA01230</companynumb>
    <primarysource>
      <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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXSANGUINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL VARICES HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO POSITIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528166-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-MERCK-0412DNK00007</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>590</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528168-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00774</companynumb>
    <primarysource>
      <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>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528170-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0412AUS00048</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528171-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0412AUS00049</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528173-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00652</companynumb>
    <primarysource>
      <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>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020318</drugenddate>
        <drugtreatmentduration>316</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE AND TRIAMTERENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528175-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA01900</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>156</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528177-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0301USA01104</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROQUICK</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528178-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00274</companynumb>
    <primarysource>
      <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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>93</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528180-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030708</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0307USA00873</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
        <drugtreatmentduration>255</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
        <drugtreatmentduration>255</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528186-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0412CAN00061</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528187-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0407USA00560</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020728</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528188-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0412CAN00078</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528189-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00465</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>1037</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>1037</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRODIURIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528190-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0412CAN00077</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528192-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0412CAN00053</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SILENT MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528195-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00872</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC PROTRUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528197-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01054</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528198-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00868</companynumb>
    <primarysource>
      <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 PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528201-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01213</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528202-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-MERCK-0412ZAF00012</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VEIN OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528203-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00923</companynumb>
    <primarysource>
      <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 DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528204-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01216</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>1371</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528207-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01066</companynumb>
    <primarysource>
      <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>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528209-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00867</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528210-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00947</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528216-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0412USA01290</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528227-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0358110A</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTONOMIC NERVOUS SYSTEM IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM REPOLARISATION ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugauthorizationnumb>18644</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIRACETAM (FORMULATION UNKNOWN) (PIRACETAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528240-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-MERCK-0412COL00015</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528255-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420920BWH</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528258-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420852BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTION INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528260-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420837BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRIAPISM</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528264-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420809BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTION INCREASED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528272-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420769BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRIAPISM</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528274-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420732BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRIAPISM</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528276-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040925</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420668BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>ERECTION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>4528280-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420632BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>NAV</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>5 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528378-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041200777</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA METASTATIC</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>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARCOXIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528379-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041200965</companynumb>
    <primarysource>
      <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>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEGIONELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA LEGIONELLA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERINFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>THE 11TH AND FINAL DOSE WAS ADMINISTERED ON 28-JUL-2004.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PYODERMA GANGRENOSUM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>PYODERMA GANGRENOSUM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERCYTE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>THROMBOCYTOPENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528380-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041201005</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528381-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-JNJFOC-20041201364</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES INSIPIDUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</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>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528382-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-JNJFOC-20041201429</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>IN TOTAL 29 INFUSIONS.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15-25 MG STARTED PRE-REMICADE TREATMENT.</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528383-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041201501</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLAZAL</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONIPIN</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BINOTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZ</medicinalproduct>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYNOTAL</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528384-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041201507</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <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>4528385-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041105090</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>4RMKA703;04B011</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL-D3</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL-D3</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528386-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20040807409</companynumb>
    <primarysource>
      <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>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528387-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041006355</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03F044A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>6-MP</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTOCORT</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528388-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20040801943</companynumb>
    <primarysource>
      <qualification>1</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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</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>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONIN</medicinalproduct>
        <drugdosagetext>START DATE: BEFORE 06-JUL-2004</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>START DATE: BEFORE 26-JAN-2004.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugdosagetext>START DATE: BEFORE 26-JAN-2004.</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>START DATE: BEFORE 26-JAN-2004</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE</medicinalproduct>
        <drugdosagetext>START DATE: BEFORE 26-JAN-2004</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugdosagetext>START DATE: BEFORE 26-JAN-2004</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARNAL</medicinalproduct>
        <drugdosagetext>START DATE: BEFORE 26-JAN-2004.</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugdosagetext>START DATE: BEFORE 26-JAN-2004.</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>START DATE: BEFORE 26-JAN-2004.</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
        <drugdosagetext>START DATE: BEFORE 26-JAN-2004.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUDIOMIL</medicinalproduct>
        <drugdosagetext>START DATE: BEFORE 26-JAN-2004.</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528389-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041002694</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HISTOPLASMOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UVEITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528390-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040809574</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>METASTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL CELL CARCINOMA</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>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSAGE ON A WHEN EVER NECESSARY BASIS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528405-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413628JP</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANDA</medicinalproduct>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528443-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-04P-028-0283003-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>800/200MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE W/LAMIVUDINE</medicinalproduct>
        <drugdosagetext>600/300</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528444-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-ABBOTT-04P-122-0282553-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528445-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-ABBOTT-04P-122-0282548-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DROOLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</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>20041106</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528446-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ABBOTT-04P-229-0282735-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPILIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528447-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0283029-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</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>MORPHINE SULFATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</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>FERROUS SULFATE TAB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HRT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIHYDROCODEINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528449-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-04P-013-0277072-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031210</drugenddate>
        <drugtreatmentduration>786</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLECALCIFEROL</medicinalproduct>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040503</drugenddate>
        <drugtreatmentduration>102</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA (COMMERCIAL)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040623</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528472-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200311191JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYONAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC                                  /JPN/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYRADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WASSER V GRAN.</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>DOSE: 5MG/WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030928</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528479-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413702JP</companynumb>
    <primarysource>
      <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>MYOGLOBIN BLOOD INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020125</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528480-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12639720</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040707</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHOPNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040707</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>TENDONITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040705</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528481-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12786117</companynumb>
    <primarysource>
      <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>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528482-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12741971</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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STOCRIN CAPS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040220</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>2/22/04: DOSE REDUCED 4 CAPS AM + 3 CAPS PM, 2/23/04: 3 CAPS TWICE/DAY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040302</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040302</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040302</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528483-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12784773</companynumb>
    <primarysource>
      <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>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>SPINAL CLAUDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPIVACAINE</medicinalproduct>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>SPINAL CLAUDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528484-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040907</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12696670</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROVEL TABS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528486-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20040900487</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMYALGIA RHEUMATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>KERION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM PICOSULFATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528487-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105099</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528488-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041000052</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.07</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528489-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419377US</companynumb>
    <primarysource>
      <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 GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCUSSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 7.5/750</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528490-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421940GDDC</companynumb>
    <primarysource>
      <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>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROHYPNOL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528491-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413472JP</companynumb>
    <primarysource>
      <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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040828</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYORIN AP 2</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528492-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040814</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200416139US</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>D027</drugbatchnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugdosagetext>DOSE: SLIDING SCALE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCRELIPASE</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528493-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200417834US</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>129.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIPHOSPHOLIPID ANTIBODIES POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041010</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528494-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421982GDDC</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN (INSULIN PUMP)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528495-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>00700 040255</companynumb>
    <primarysource>
      <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugdosagetext>DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528496-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12659355</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOG CREAM 0.1%</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>SKIN GRAFT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACITRACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528497-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12683587</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOG CREAM 0.1%</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DERMATITIS ALLERGIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACITRACIN ZINC</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>SKIN GRAFT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528498-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12732863</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528499-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SOLVAY-00204004363</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYCLIC VOMITING SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARINOL</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 25 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPIODS</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528500-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-BRISTOL-MYERS SQUIBB COMPANY-12789244</companynumb>
    <primarysource>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COAPROVEL TABS 150MG/12.5MG</medicinalproduct>
        <drugdosagetext>DOSAGE FORM= 150 MG + 12.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040503</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528501-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12768230</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELISOR TABS 20 MG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>306</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELISOR TABS 20 MG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METABOLIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>306</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981012</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528502-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12786463</companynumb>
    <primarysource>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA PSYCHOGENIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROVEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXAPINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATHYMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSANXIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METEOSPASMYL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUBENTYL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMPORTAL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040812</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528503-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12789202</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ CAPS</medicinalproduct>
        <drugdosagetext>LAST TAKEN ON 25-OCT-2004</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>LAST TAKEN ON 25-OCT-2004</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031024</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HCL</medicinalproduct>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528504-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12784807</companynumb>
    <primarysource>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAFCILLIN SODIUM</medicinalproduct>
        <drugindication>STAPHYLOCOCCAL BACTERAEMIA</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugindication>STAPHYLOCOCCAL BACTERAEMIA</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
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  <safetyreport>
    <safetyreportid>4528505-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031003</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-184-2003</companynumb>
    <primarysource>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030618</drugstartdate>
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    </patient>
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    <safetyreportid>4528506-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
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    <receiptdate>20031027</receiptdate>
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    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12420550</companynumb>
    <primarysource>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
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  <safetyreport>
    <safetyreportid>4528507-7</safetyreportid>
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    <transmissiondate>20050328</transmissiondate>
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    <receivedateformat>102</receivedateformat>
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    <receiptdate>20031110</receiptdate>
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    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12431946</companynumb>
    <primarysource>
      <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>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
        <drugbatchnumb>2K66528</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
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        <drugstartdate>20031001</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
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    <safetyreportid>4528508-9</safetyreportid>
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    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
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    <receiptdate>20031201</receiptdate>
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    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12447777</companynumb>
    <primarysource>
      <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>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
        <drugbatchnumb>3A63685</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
        <drugdosagetext>DOSAGE FORM = TABLETS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLIMARA</medicinalproduct>
        <drugdosagetext>DOSAGE FORM = PATCH</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528509-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031211</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12457727</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHOLESTYRAMINE</medicinalproduct>
        <drugbatchnumb>1G52971</drugbatchnumb>
        <drugdosagetext>DOSAGE FORM = SCOOP</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONNATAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528510-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12477824</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528511-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12478673</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHOLESTYRAMINE</medicinalproduct>
        <drugbatchnumb>3A63681</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528512-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12485942</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENSTRUAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
        <drugindication>POLYCYSTIC OVARIES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528513-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12501698</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHOLESTYRAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528514-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12509501</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528515-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040224</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12515508</companynumb>
    <primarysource>
      <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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528516-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040309</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12528709</companynumb>
    <primarysource>
      <qualification>5</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>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
        <drugbatchnumb>3A63685</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASERETIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528517-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040331</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12548483</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
        <drugbatchnumb>3A63685</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528518-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040406</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12552386</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHOLESTYRAMINE</medicinalproduct>
        <drugdosagetext>DOSE INCREASED TO 2 MEASURING SPOONS DAILY ON 29-MAR-2004</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040404</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528519-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040407</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12554309</companynumb>
    <primarysource>
      <qualification>5</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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHOLESTYRAMINE</medicinalproduct>
        <drugbatchnumb>030091</drugbatchnumb>
        <drugdosagetext>THERAPY WAS TAKEN FOR 2 MONTHS STARTING FEB 2003, STOPPED, AND THEN RESTARTED 01-APR-2004</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528520-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040422</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12568127</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHOLESTYRAMINE</medicinalproduct>
        <drugbatchnumb>3G74508</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528521-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040423</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12569067</companynumb>
    <primarysource>
      <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>DYSPNOEA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHOLESTYRAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EXPOSURE TO TOXIC AGENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040422</drugstartdate>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4528522-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12573820</companynumb>
    <primarysource>
      <qualification>2</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
        <drugbatchnumb>3A63687</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528523-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040518</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12590113</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528524-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040518</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12590212</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528525-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040521</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12593836</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528526-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12639415</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
        <drugdosagetext>1 SCOOP/DAY = DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528527-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12644274</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040717</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528528-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12660742</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHOLESTYRAMINE</medicinalproduct>
        <drugbatchnumb>040339</drugbatchnumb>
        <drugdosagetext>DOSAGE FORM = SCOOP</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</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 B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COENZYME Q10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROITIN + GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENASTAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528529-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12669545</companynumb>
    <primarysource>
      <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
        <drugdosagetext>DOSE FREQUENCY: ^EVERY MEAL^</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEPHROLITHIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528530-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040820</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12679049</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHOLESTYRAMINE</medicinalproduct>
        <drugbatchnumb>2A59166</drugbatchnumb>
        <drugdosagetext>ALSO TOOK LAST YEAR FOR 2 WEEKS (UNSPECIFIED DATES) AND EXPERIENCED HEARTBURN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOOSE STOOLS</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRATEST H.S.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528531-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040827</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12685582</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHOLESTYRAMINE</medicinalproduct>
        <drugbatchnumb>3H66513</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHOLECYSTECTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>DURATION OF THERAPY:  ^A FEW YEARS^</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>DURATION OF THERAPY:  ^A FEW YEARS^</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>DURATION OF THERAPY:  ^A FEW YEARS^</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
        <drugdosagetext>DURATION OF THERAPY:  ^A FEW YEARS^</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528532-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12705943</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
        <drugbatchnumb>3D65297</drugbatchnumb>
        <drugdosagetext>1 SCOOP THREE TIMES DAILY</drugdosagetext>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528533-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12706396</companynumb>
    <primarysource>
      <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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528534-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12707121</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
        <drugdosagetext>DOSAGE FORM = SCOOPS</drugdosagetext>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528535-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12710596</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHOLESTYRAMINE</medicinalproduct>
        <drugbatchnumb>040459</drugbatchnumb>
        <drugdosagetext>DOSAGE FORM = SCOOPS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARASITIC INFECTION INTESTINAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528536-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12728234</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>105</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
        <drugbatchnumb>3863687</drugbatchnumb>
        <drugdosagetext>DOSAGE FORM = SCOOP</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST GASTRIC SURGERY SYNDROME</drugindication>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528537-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12742318</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
        <drugdosagetext>DOSAGE FORM = TEASPOON</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTESTINAL RESECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528538-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12748711</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHOLESTYRAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528539-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12793162</companynumb>
    <primarysource>
      <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>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADOSE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528540-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12772976</companynumb>
    <primarysource>
      <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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>THERAPY INITIATED 01-OCT-2004,GIVEN WEEKLY WEEKS 1-8</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>THERAPY INITIATED 08-OCT-04,GIVEN ON WEEKS 1,2,4, AND 5</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugdosagetext>THERAPY INITIATED 08-OCT-04,GIVEN WEEK 1,2,4 AND 5</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugdosagetext>DOSE 180 CGY-CENTOGRAY (DAY 15 WEEK 1-5). COMPLETED THERAPY 17-NOV-04</drugdosagetext>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAOPECTATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugdosagetext>1% GEL</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528541-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040903</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12693032</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040725</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVALBUTEROL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROSE 5% 1/2 NORMAL SALINE + KCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528542-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040721</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0267776-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLASGOW COMA SCALE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOCTRAN 10</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLATE LYSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSILANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRIBEDIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040421</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528543-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0282845-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL VENTRICLE DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMMUNICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL MACROCEPHALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL COORDINATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL DYSMORPHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL RETARDATION SEVERITY UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL PROBLEM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528544-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0275396-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL CONDITION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</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>20030922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUSIDIC CREAM</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>METFORMIN HCL</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>PARACETAMOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN ASPART</medicinalproduct>
        <drugdosagetext>3 ML PEN, 100/ML</drugdosagetext>
        <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>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</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>LOSARTEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>058</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>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528545-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0273673-00</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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL CONDITION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040709</drugenddate>
        <drugtreatmentduration>290</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</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>ALENDRONATE SODIUM</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>VALSARTAN</medicinalproduct>
        <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>LANSOPRAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUSIDIC CREAM</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>METFORMIN HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN ASPART</medicinalproduct>
        <drugdosagetext>100/ML 3ML PEN</drugdosagetext>
        <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>LOSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528546-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0283145-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</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>KALETRA</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040506</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040506</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040506</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE W/LAMIVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040506</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528547-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-04P-087-0282419-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVORANE LIQUID FOR INHALATION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>0.5-2%</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>URINE OUTPUT DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICHLORMETHIAZIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIAMYLAL SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>EPIDURAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>10 MICROGRAMS/HR</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDOCAINE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>ROUTE T1</drugdosagetext>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPIVACAINE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>EPIDURAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPIVACAINE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1 MILLIGRAM/HOUR</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>^DR^</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>HYPOTENSIVE ANAESTHESIA PROCEDURE</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPROSTADIL</medicinalproduct>
        <drugdosagetext>^DR^</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPROSTADIL</medicinalproduct>
        <drugindication>HYPOTENSIVE ANAESTHESIA PROCEDURE</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>^DR^</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugindication>HYPOTENSIVE ANAESTHESIA PROCEDURE</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>^DR^</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528548-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-04P-087-0282420-00</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 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVORANE LIQUID FOR INHALATION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ARRHYTHMIA SUPRAVENTRICULAR</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ARRHYTHMIA SUPRAVENTRICULAR</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMYLAL SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528549-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ABBOTT-04P-008-0282519-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CATATONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528550-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0282719-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD IRON NORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPANTHYL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528551-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0282558-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEMORAL NECK FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APOREX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAXAM GEL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASONE BUTYRATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNARIZINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528552-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0281153-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE MITE</medicinalproduct>
        <drugdosagetext>500/50</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugindication>ELECTROLYTE SUBSTITUTION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIBADREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528553-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-04P-020-0282385-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528554-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-04P-028-0282004-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SUFENTANIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE</medicinalproduct>
        <drugdosagetext>3 LITERS PER MINUTE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugdosagetext>3 LITERS PER MINUTE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGEN SUPPLEMENTS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528555-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-04P-028-0282024-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SUFENTANIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE</medicinalproduct>
        <drugdosagetext>3 LITERS PER MINUTE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugdosagetext>3 LITERS PER MINUTE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONE REPLACEMENT THERAPY</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528556-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-04P-028-0282031-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SUFENTANIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE</medicinalproduct>
        <drugdosagetext>3 LITERS PER MINUTE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugdosagetext>3 LITERS PER MINUTE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528557-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0279339-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528558-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE04064</companynumb>
    <primarysource>
      <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 CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE IMMEASURABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528559-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE04185</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugdosagetext>10 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRAZEPAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528560-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004PL16651</companynumb>
    <primarysource>
      <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>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>200 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528561-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE04173</companynumb>
    <primarysource>
      <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>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528562-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004IT16451</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LICHEN PLANUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPERPIGMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB</medicinalproduct>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528563-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040824</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP11325</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>125 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040820</drugenddate>
        <drugtreatmentduration>17280</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALESION</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040223</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528564-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040909</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP11933</companynumb>
    <primarysource>
      <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>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENIVACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>600 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528565-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP13331</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMOX</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFLAN</medicinalproduct>
        <drugdosagetext>75 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCELASE</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PONTAL</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040911</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>5 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugdosagetext>3000 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>300 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE-ALPHA</medicinalproduct>
        <drugdosagetext>0.5 UG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040714</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528566-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03645</companynumb>
    <primarysource></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>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HMG COA REDUCTASE INHIBITORS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528567-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03658</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>900 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
        <drugtreatmentduration>40320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
        <drugtreatmentduration>48960</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFU K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528568-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE04151</companynumb>
    <primarysource>
      <qualification>1</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>GLEEVEC</medicinalproduct>
        <drugdosagetext>400MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040619</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528569-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040908</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004GR11864</companynumb>
    <primarysource>
      <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>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>75 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>INFLUENZA LIKE ILLNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040908</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040908</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALOSPIR</medicinalproduct>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KERLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCURETIC</medicinalproduct>
        <drugdosagetext>0.5 TABLET/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACYT</medicinalproduct>
        <drugdosagetext>140 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040818</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528570-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16526</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>50 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040517</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528571-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13162</companynumb>
    <primarysource>
      <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>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528572-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03572</companynumb>
    <primarysource></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>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERCALCAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>800 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER FEMALE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FARMORUBICINE</medicinalproduct>
        <drugdosagetext>170 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER FEMALE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL ^ROCHE^</medicinalproduct>
        <drugdosagetext>800 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER FEMALE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDIOXANE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>AGRANULOCYTOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528573-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13005</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LITHOTRIPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugdosagetext>200 IU, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>UNK, QW</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528574-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004NO16618</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>100</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
        <drugtreatmentduration>370</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBYL-E</medicinalproduct>
        <drugdosagetext>75 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
        <drugtreatmentduration>370</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUROFERON</medicinalproduct>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>1 G, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528575-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE04013</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>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>1500 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>37.5 MG, BIW</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALMADORM</medicinalproduct>
        <drugdosagetext>0.5 DF/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528576-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004PL16652</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL CENTRAL NERVOUS SYSTEM ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL FLOPPY INFANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL MALPOSITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROGENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL APNOEIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL ASPHYXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPISTHOTONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL TESTICLE EXAMINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528577-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04523</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>200MG/NOCTE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
        <drugdosagetext>125 MG, 6QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELEGILINE HCL</medicinalproduct>
        <drugdosagetext>10MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERGOLIDE MESYLATE</medicinalproduct>
        <drugdosagetext>250MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528578-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004KR14676</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528579-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13178</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528580-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004IT16585</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECG SIGNS OF MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QRS AXIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>600 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
        <drugtreatmentduration>18720</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>300 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>2 MG/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
        <drugtreatmentduration>46080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugdosagetext>300 MG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELTACORTENE</medicinalproduct>
        <drugdosagetext>5 MG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>500 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN I</medicinalproduct>
        <drugdosagetext>28 IU/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>25 IU/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIOASPIRIN</medicinalproduct>
        <drugdosagetext>10 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugdosagetext>25 MG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugdosagetext>200 MG/D</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG/D</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528581-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04489</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVASTIGMINE</medicinalproduct>
        <drugdosagetext>3MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528582-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP14473</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>53280</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERSANTIN</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
        <drugtreatmentduration>23040</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACECOL</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528583-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE04118</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>250 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTINEOPLASTIC AGENTS</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528584-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04505</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528585-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04522</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORTHALIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528586-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BR16702</companynumb>
    <primarysource>
      <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>GASTRIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528587-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03629</companynumb>
    <primarysource>
      <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>ANTIPSYCHOTIC DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugdosagetext>350 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528588-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040722</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE02610</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC DISORDER</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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS ROTAVIRUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUTAMATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENTERITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040618</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVONORM</medicinalproduct>
        <drugdosagetext>.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCOL</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040618</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528589-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CN16555</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040515</drugenddate>
        <drugtreatmentduration>33120</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETALOC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528590-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16604</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031115</drugenddate>
        <drugtreatmentduration>28800</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCHOL</medicinalproduct>
        <drugdosagetext>60 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031027</drugenddate>
        <drugtreatmentduration>18720</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCHOL</medicinalproduct>
        <drugdosagetext>30 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031126</drugenddate>
        <drugtreatmentduration>15840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528591-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16257</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030826</drugenddate>
        <drugtreatmentduration>537</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCINE + VINCRISTINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOCELL THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528592-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03628</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL PRURITUS FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIKOLSKY'S SIGN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMORPHIC LIGHT ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DESQUAMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040906</drugenddate>
        <drugtreatmentduration>53280</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTIM</medicinalproduct>
        <drugadministrationroute>008</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELESTENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
        <drugtreatmentduration>43200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EUPANTOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040906</drugenddate>
        <drugtreatmentduration>53280</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMALINE</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040815</drugenddate>
        <drugtreatmentduration>21600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528593-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2003JP07813</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL RETARDATION SEVERITY UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEFENAMIC ACID</medicinalproduct>
        <drugdosagetext>2 ML, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>12.5 MG/DAY</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528594-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15207</companynumb>
    <primarysource>
      <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>ANTIBODY TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENURESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS ASEPTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY GLAND ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SJOGREN'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>25 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001208</drugenddate>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528595-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16379</companynumb>
    <primarysource>
      <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>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528596-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13157</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugdosagetext>200 IU, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528597-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12795274</companynumb>
    <primarysource>
      <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>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOMIDE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROMITEXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODEOXYCHOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528598-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12790176</companynumb>
    <primarysource>
      <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>ALCOHOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA PSYCHOGENIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROVEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KERLONE</medicinalproduct>
        <drugdosagetext>LONG-TERM TRT</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528599-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12789616</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KAPOSI'S SARCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020423</drugenddate>
        <drugtreatmentduration>427</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STOCRIN CAPS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030213</drugenddate>
        <drugtreatmentduration>296</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020325</drugenddate>
        <drugtreatmentduration>409</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528600-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16663</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugdosagetext>10 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
        <drugdosagetext>270 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528601-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CH16370</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONIC CLONIC MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORANGIN ^NOVARTIS^</medicinalproduct>
        <drugdosagetext>40 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>400 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528602-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15486</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>40 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
        <drugtreatmentduration>635</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>60 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELOKEN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFZON</medicinalproduct>
        <drugdosagetext>100 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PL GRAN.</medicinalproduct>
        <drugdosagetext>1 G, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>100 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528603-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16524</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>3</patientweight>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTUBATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOGENESIS IMPERFECTA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528604-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US10013</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>137</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>UNK,UNK</drugdosagetext>
        <drugindication>FACIAL NERVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>ONE TAB. DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528605-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004JP17677</companynumb>
    <primarysource>
      <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>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THALAMUS HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040130</drugenddate>
        <drugtreatmentduration>225</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SELECTOL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980812</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528606-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12533</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>ONE PUFF , BID</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugdosagetext>TWO SPRAYS DAILY</drugdosagetext>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugbatchnumb>037J3347</drugbatchnumb>
        <drugdosagetext>80/12.5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>92160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528607-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US10539</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEQUESTRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTIN</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEONECROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugdosagetext>1 G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEONECROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528608-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041202819</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS NEUROSENSORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528609-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12965</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DENTAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY THERAPY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528610-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04466</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT SL - SLOW RELEASE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIFLEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>800MG + 600MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528611-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04498</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>600MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugdosagetext>150/75MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528612-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12558</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>ONE TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528613-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA00296</companynumb>
    <primarysource>
      <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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMOGRAPHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCRATCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXALT RPD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXALT RPD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXALT RPD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXALT RPD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXALT RPD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041024</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXALT RPD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FURSULTIAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERNELIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRONASE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORMETAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERIZYME</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYALURONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WAX, WHITE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PETROLATUM, WHITE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE DIPROPIONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE VALERATE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALMETA</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EURAX</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARINOID</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOMOCLOMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528614-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041202134</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOE VERA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528615-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004NZ17489</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041209</drugenddate>
        <drugtreatmentduration>200</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528616-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE01922</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS PROLIFERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>160 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040416</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528617-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004DE01296</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>240 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040115</drugenddate>
        <drugtreatmentduration>69120</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>220 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040116</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>200 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040117</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>180 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040118</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>160 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FTY720 VS MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528618-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01194</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM CD</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528619-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0202USA01025</companynumb>
    <primarysource>
      <qualification>1</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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST-T CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENIS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEBORRHOEIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010202</drugenddate>
        <drugtreatmentduration>184</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010202</drugenddate>
        <drugtreatmentduration>184</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC EXTRACT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>Z-PAK</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528620-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040901</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0409USA00309</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE BB INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RYTHMODAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BARNIDIPINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM POLYSTYRENE SULFONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMAZOLON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRANDOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528621-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040924</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0410GBR00028</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SCHISTOCYTES PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETICULOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030317</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030317</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030315</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030315</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030315</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528622-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0407USA01744</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>143</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020103</drugenddate>
        <drugtreatmentduration>254</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020103</drugenddate>
        <drugtreatmentduration>254</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528623-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0410AUS00107</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE REDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIMOPTIC</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIMATOPROST</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040513</drugenddate>
        <drugtreatmentduration>381</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528624-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BR16632</companynumb>
    <primarysource>
      <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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODATEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528625-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16546</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSYCHIATRIC THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOMIPRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPIRIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528626-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040811</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0408USA00967</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC STRESS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VEIN OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528627-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040924</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0410GBR00028</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETICULOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030317</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030317</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030315</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030315</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030315</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528628-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030513</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2003TR06059</companynumb>
    <primarysource>
      <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>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>2000MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNOL</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>150MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020402</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528629-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-MERCK-0411KOR00003</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYALURONATE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528630-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-MERCK-0411CHE00046</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528631-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03530</companynumb>
    <primarysource>
      <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>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528632-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA00984</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>1285</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JOINT SWELLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>1285</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528633-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00093</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NECK INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040304</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040304</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NALOXONE HYDROCHLORIDE AND TILIDINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLPERISONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528634-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03723</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528635-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00224</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>112</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MONARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528636-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040917</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0409FRA00072</companynumb>
    <primarysource>
      <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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACEPROMAZINE AND ACEPROMETAZINE AND CLORAZEPATE DIPOTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040912</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528637-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0533534A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ECOTRIN REGULAR STRENGTH TABLETS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCOAGULATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEANO TABLETS</medicinalproduct>
        <drugbatchnumb>4D26</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLATULENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE PILL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOVITAMINOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528638-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0534960A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAUSTIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BC POWDER</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528639-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535655A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>97</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528640-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535793A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE SUPRANUCLEAR PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN THERAPY</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528641-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-04967</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528642-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GLAXOSMITHKLINE-A0536231A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIQUITIN 21MG</medicinalproduct>
        <drugbatchnumb>0422915-21</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528643-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536444A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ECOTRIN REGULAR STRENGTH TABLETS</medicinalproduct>
        <drugbatchnumb>4H02</drugbatchnumb>
        <drugdosagetext>1TAB SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>.25MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528644-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536714A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CARCINOMA CELL TYPE UNSPECIFIED RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE (MINT)</medicinalproduct>
        <drugbatchnumb>FE511B</drugbatchnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE PLUS D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORA TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528645-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536715A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940101</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUMS ULTRA TABLETS, ASSORTED FRUIT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>8TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528646-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536754A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENERGY INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMINEX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528647-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421598GDDC</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528648-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421641GDDC</companynumb>
    <primarysource>
      <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>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL POLYPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANT (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDRONEL PMO</medicinalproduct>
        <drugdosagetext>1PACK AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528649-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537141A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIVARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528650-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421892GDDC</companynumb>
    <primarysource>
      <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>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-PSYCHOTIC MEDICATION</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURAZEPAM HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528651-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041005574</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATRECOR</medicinalproduct>
        <drugdosagetext>2 UG/KD BOLUS FOLLOWED BY 0.01 UG/KG/MINUTE AS INFUSION OVER FOUR HOURS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLGARD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528652-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041005638</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATRECOR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATRECOR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIDENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528653-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20041203235</companynumb>
    <primarysource>
      <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>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREPULSID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DIABETIC GASTROPARESIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041010</drugenddate>
        <drugtreatmentduration>622</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528654-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041202493</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREPULSID</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528655-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041002813</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.16</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
        <drugdosagetext>PM DOSE.</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
        <drugdosagetext>AM DOSE</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICYCLOMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCUVITE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCUVITE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCUVITE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUTEIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528656-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16550</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSED MOOD</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAZOLAM</medicinalproduct>
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  <safetyreport>
    <safetyreportid>4528657-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
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    <receiptdate>20040115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0401USA01205</companynumb>
    <primarysource>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH OF SPOUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORY NEUROPATHY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031114</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031114</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRODIURIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRODIURIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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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>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (UNSPECIFIED)</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>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>4528658-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
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    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00005</companynumb>
    <primarysource>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIASTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXERCISE TOLERANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE HEART DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-CARDIAC CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC PROTRUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528659-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0412FRA00033</companynumb>
    <primarysource>
      <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>NEUROENDOCRINE CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBILEUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528660-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00553</companynumb>
    <primarysource>
      <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>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOCORTOLONE CAPROATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SITOSTEROLS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL XINAFOATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528661-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00998</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528662-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0412CAN00087</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVASTATIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GOUT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528663-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA02629</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528664-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA01133</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>1422</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528665-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01338</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528666-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00864</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528667-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040805025</companynumb>
    <primarysource>
      <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>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528668-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01309</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>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICYCLOMINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLIDINIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528669-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01096</companynumb>
    <primarysource>
      <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>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528670-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01084</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528671-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01312</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528672-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01099</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528673-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01210</companynumb>
    <primarysource>
      <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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528674-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00951</companynumb>
    <primarysource>
      <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>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528675-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00994</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528676-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01405</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528677-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>4528678-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
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    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <qualification>5</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE AND TRIAMTERENE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528679-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
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    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0412AUS00035</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
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        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
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  <safetyreport>
    <safetyreportid>4528680-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
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    <receivedateformat>102</receivedateformat>
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      <qualification>4</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>4528681-2</safetyreportid>
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    <transmissiondate>20050328</transmissiondate>
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    <receivedateformat>102</receivedateformat>
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    <receiptdate>20041123</receiptdate>
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    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
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        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
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        <drugstartdate>20040830</drugstartdate>
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        <drugstartdate>20040721</drugstartdate>
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      <drug>
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        <medicinalproduct>CLONIDINE</medicinalproduct>
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        <drugstartdate>20030901</drugstartdate>
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        <drugstartdate>20030901</drugstartdate>
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      <drug>
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        <drugstartdate>20030901</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLESTIPOL HCL</medicinalproduct>
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        <drugstartdate>20030901</drugstartdate>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
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        <medicinalproduct>LASIX</medicinalproduct>
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        <drugstartdate>20030901</drugstartdate>
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        <drugcharacterization>2</drugcharacterization>
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        <drugstartdate>20030901</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
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        <drugstartdate>20030901</drugstartdate>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGULAR INSULIN</medicinalproduct>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE NASAL SPRAY</medicinalproduct>
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        <drugindication>NASAL CONGESTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19790101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528682-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BOEHRINGER INGELHEIM PHARMMACEUTICALS, INC.-2004-BP-13100BR</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>95</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAMIFIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528683-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105794</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.48</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULT TO WEAN FROM VENTILATOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETERIC OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528684-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03031</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528685-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20041005317</companynumb>
    <primarysource>
      <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>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>DOSE STARTED ON DAY 39 POSTHOSPITALIZATION.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>DOSE STARTED ON DAY 32 POSTHOSPITALIZATION.</drugdosagetext>
        <drugindication>DRUG THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugdosagetext>DOSE STARTED ON DAY 19 POSTHOSPITALIZATION.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugdosagetext>DOSE STARTED ON DAY 8 POSTHOSPITALIZATION.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528688-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200418006BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528689-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040806</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200418019BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528690-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200418137BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugdosagetext>40 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528691-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200418186BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAW PALMETTO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C</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>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528692-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040806</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200418392BWH</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>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528693-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040806</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200418402BWH</companynumb>
    <primarysource></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>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528694-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200418443BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE REDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528695-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200418506BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528696-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200418526BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VAIGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528697-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200418579BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugdosagetext>20 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528698-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200418610BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528699-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200418677BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EJACULATION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528700-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200418730BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, BIW, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528701-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200418766BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040624</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528702-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200418870BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, PRN ; 20 MG, TOTAL DAILY   : ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, PRN ; 20 MG, TOTAL DAILY   : ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528703-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200418877BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.5964</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528704-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040813</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200419033BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, BIW, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528705-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200419074BWH</companynumb>
    <primarysource></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>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528706-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200419075BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528707-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200419092BWH</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>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040707</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528708-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200419096BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TESTICULAR SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528718-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420841BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528719-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420843BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528720-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420844BWH</companynumb>
    <primarysource></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>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>^A SHOT IN THE PENIS^</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528721-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420846BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>149.687</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENIS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528722-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420848BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PENILE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMATURE EJACULATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528723-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420850BWH</companynumb>
    <primarysource></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>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528724-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420858BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXB95B1</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXB95B1</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528725-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420859BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528726-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420861BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE FLOW DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXBCLC1</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>30 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATECTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528727-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420862BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXBAKD1</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXBAKD1</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXBAKD1</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXBAKD1</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528728-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420863BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528729-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420868BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN L</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528730-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420874BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528731-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420875BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528732-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12770418</companynumb>
    <primarysource>
      <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>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY MONILIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CPT-11</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528733-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LB-BRISTOL-MYERS SQUIBB COMPANY-12794301</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COAPROVEL TABS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040520</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528734-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420876BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETIC MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528735-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12790606</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRIPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040315</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040317</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528736-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420879BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528737-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420885BWH</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>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528738-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420887BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EJACULATION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>5 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528739-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420888BWH</companynumb>
    <primarysource></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>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN SUPPLEMENTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528740-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041023</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420889BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94.3482</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528741-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031006</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-348565</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROFERON-A</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010615</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940615</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010615</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010615</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYNT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOBAY</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528742-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-2004-036295</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION THREATENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY ON ORAL CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>21098</drugauthorizationnumb>
        <drugdosagetext>1 TAB(S), 1X/DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040604</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>4528743-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-2004-036033</companynumb>
    <primarysource>
      <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>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DESQUAMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>21098</drugauthorizationnumb>
        <drugdosagetext>1 TAB(S), 21D/28D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
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        <drugenddate>20041101</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>4528744-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
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    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-2004-035981</companynumb>
    <primarysource>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY ALLERGIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
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        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040413</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCTOSEDYL SUPPOSITORY ^ROCHE^ (ESCULOSIDE, BENZOCAINE, HYDROCORTISON</medicinalproduct>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528745-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
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    <seriousnesslifethreatening>1</seriousnesslifethreatening>
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    <receivedate>20041216</receivedate>
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    <companynumb>JP-ROCHE-375191</companynumb>
    <primarysource>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
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      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM P WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040708</drugenddate>
        <drugtreatmentduration>361</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERBESSER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINIPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAONIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIYA BM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPD</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS MILTAX (KETOPROFEN).</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MASI-NIN-GAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>ON AN UNSPECIFIED DATE THE DOSE WAS INCREASED TO 2MG.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528746-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2004-034752</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528747-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031007</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-348915</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOLERANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528748-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-371204</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>12</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040605</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040606</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040606</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTOMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040616</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERIACTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040616</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040616</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOKUNALIN</medicinalproduct>
        <drugdosagetext>FORMULATION: TAPE.</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040616</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOPHYLLIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040607</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528749-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040611</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-371033</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR GROWTH ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTRICHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugbatchnumb>B0030</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugbatchnumb>B0030</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugbatchnumb>U3077</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugbatchnumb>U3077</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040818</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528750-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-2004-034317</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528751-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-2004-033080</companynumb>
    <primarysource>
      <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>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>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980113</drugstartdate>
        <drugtreatmentduration>2555</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528752-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-2004-036323</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugtreatmentduration>730</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528753-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-373611</companynumb>
    <primarysource>
      <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>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HELIXATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040510</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTISKENAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOPHIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040416</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528754-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-384337</companynumb>
    <primarysource>
      <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>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ALVEOLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528755-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-388631</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>FORM: INJECTABLE POWDER</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528756-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004093693</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTONIC BLADDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOSTINEX</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>(0.25 MG, TWICE ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPROLACTINAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM (CLOBAZAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOMEGESTROL (NOMEGESTROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOMIPRAMINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528757-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040901</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ROCHE-379163</companynumb>
    <primarysource>
      <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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>INTERMITTENT TREATMENT - TWO WEEKS OF TREATMENT FOLLOWED BY ONE WEEK REST.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>INTERMITTENT THERAPY - TWO WEEKS TREATMENT FOLLOWED BY ONE WEEK REST.  DOSE GIVEN EQUATES TO 2100MG.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCOUMAR</medicinalproduct>
        <drugdosagetext>PRN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040827</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIQUAEMIN INJ</medicinalproduct>
        <drugdosagetext>35000 UNIT DOSING GIVEN 26-28 AUGUST, 2004, 15000 UNIT DOSE GIVEN 31 AUGUST, 2004.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528758-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-385963</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXANTHEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRIDOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528759-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-388497</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
        <drugtreatmentduration>337</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS 2-O-3/D TWO IN THE MORNING AND THREE IN THE EVENING PER DAY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
        <drugtreatmentduration>337</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
        <drugtreatmentduration>351</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-THYROXINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugdosagetext>^DRUG REPORTED AS ^SODID^</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528760-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040816</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-378005</companynumb>
    <primarysource>
      <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040814</drugenddate>
        <drugtreatmentduration>72</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040814</drugenddate>
        <drugtreatmentduration>72</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK THISTLE</medicinalproduct>
        <drugdosagetext>HAD BEEN USED FOR THREE MONTHS SO FAR.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528761-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ROCHE-383143</companynumb>
    <primarysource>
      <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>COMPLICATIONS OF TRANSPLANTED KIDNEY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL CYSTIC KIDNEY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION PSEUDOMONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>NO UNITS PROVIDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANUBER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528762-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-545</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BETA-D-GLUCAN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>6 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN (LOXOPROFEN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SHIOSOL (SODIUM AUROTHIOMALATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIMETHASONE (DEXAMETHASONE PALMITATE/GLYCEROL/LECITHIN/SOYA OIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528763-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ROCHE-387851</companynumb>
    <primarysource>
      <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>SOCIAL PHOBIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19890615</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910615</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528764-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-387340</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GANGLION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528765-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-388399</companynumb>
    <primarysource>
      <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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PILONIDAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETHRAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040812</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRABENAZINE</medicinalproduct>
        <drugdosagetext>DRUG NAME: XENAZINE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040803</drugenddate>
        <drugtreatmentduration>896</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRABENAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOCET</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040812</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILLIGYNON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERESTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528766-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-ROCHE-388542</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528767-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-ROCHE-388534</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXITETRACYCLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528768-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-554</companynumb>
    <primarysource>
      <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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>6 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>4 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>6 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROM (ESCABET MONOSODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFA D (ALFACLACIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SHIOSOL (SODIUM AUROTHIOMALATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528769-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-ROCHE-388705</companynumb>
    <primarysource>
      <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>ARTERIOVENOUS MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041205</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVATRIL</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528770-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-388641</companynumb>
    <primarysource>
      <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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980315</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528771-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-388897</companynumb>
    <primarysource>
      <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528772-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-388684</companynumb>
    <primarysource>
      <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>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTEROIDES INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO SPLEEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURITIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>GIVEN ON DAYS 1 THROUGH 21 (LENGTH OF CYCLE NOT REPORTED).  ACTUAL DOSE ADMINISTERED EQUATES TO 230+</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>GIVEN ON DAYS 1, 8 AND 15 (LENGTH OF CYCLE NOT REPORTED).  ACTUAL DOSE ADMINSTERED EQUATES TO 1380M+</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUDAFED S.A.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528773-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-384</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>BETA 2 MICROGLOBULIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>10 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG 2X PER 1 WK, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040715</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528774-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-613</companynumb>
    <primarysource>
      <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>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICES OESOPHAGEAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>3 X 2.5 MG TABLETS WEEKLY</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULATARD NPH HUMAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA (ROSIGLITAZONE MALAEATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528775-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-388991</companynumb>
    <primarysource>
      <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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000907</drugenddate>
        <drugtreatmentduration>155</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL PILL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528776-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-615</companynumb>
    <primarysource>
      <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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>4 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>6 MG 1X PER 1 WK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN (LOXOPROFEN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX (TEPRENONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528777-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-389277</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528778-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040908</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-616</companynumb>
    <primarysource>
      <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>9 MG PER WEEK; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA NICOTINATE (TOCOPHERYL NICOTINATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL (MECOBALAMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLATREN (DICLOFENAC SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528779-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-389058</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>110</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORLISTAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528780-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-388906</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN K</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528781-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-1999-024315</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>3.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL CONDITION AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>19596</drugauthorizationnumb>
        <drugdosagetext>UNK, 1 DOSE; TRANSPLACENTAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980113</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528782-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RENA-11186</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST NEGATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugauthorizationnumb>21179</drugauthorizationnumb>
        <drugdosagetext>0.25 G TID; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEZAFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBROXOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN ALFA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528783-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-00565</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION IN AN IMMUNOCOMPROMISED HOST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCROTAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC INFLAMMATORY RESPONSE SYNDROME</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>20040330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA BLOCKING AGENTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528784-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02442</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAROPIN</medicinalproduct>
        <drugauthorizationnumb>20533</drugauthorizationnumb>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAROPIN</medicinalproduct>
        <drugdosagetext>10 ML /HR ED</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528785-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>209274</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIASTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXANTHEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB) CONC FOR  SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>730 MG, 1/WEEK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB) CONC FOR  SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>730 MG, 1/WEEK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA (RITUXIMAB) CONC FOR  SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>730 MG, 1/WEEK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PINEX FORTE (ACETAMINOPHEN, CODEINE PHOSPHATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARISOPRODOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACINE CHLORHYDRATE (CIPROFLOXACIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALTEPARIN (DALTEPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID (INSULIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN (CLINDAMYCIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MALEATE (ENALAPRIL MALEATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOTAXIME SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528786-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>209725</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA(RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>680 MG, 1/WEEK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE(ESOMEPRAZOLE MAGNESIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARISOPRODOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PINEX FORTE (CODEINE PHOSPHATE, ACETAMINOPHEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCEROL (GLYCERIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXCHLORPHENIRAMINE (DEXCHLORPHENIRAMINE MALEATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROID NOS (STEROID NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528787-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CERZ-10726</companynumb>
    <primarysource>
      <qualification>1</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>20367</drugauthorizationnumb>
        <drugdosagetext>8000 UNITS Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGENYL CHRONO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGENYL-SLOW RELEASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRACETAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTELEPSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM BETA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528788-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP02010</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugauthorizationnumb>20498</drugauthorizationnumb>
        <drugdosagetext>150 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEMOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528789-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02328</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIDURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IATROGENIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOSOCOMIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUNCTURE SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMLA</medicinalproduct>
        <drugauthorizationnumb>19941</drugauthorizationnumb>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMLA</medicinalproduct>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMLA</medicinalproduct>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETADINE</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETADINE</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETADINE</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528790-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-591</companynumb>
    <primarysource>
      <qualification>3</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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN (LOXOPROFEN SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528791-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12634929</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOLATE DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX EC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040713</drugenddate>
        <drugtreatmentduration>147</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040713</drugenddate>
        <drugtreatmentduration>147</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040331</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528792-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>25701</companynumb>
    <primarysource></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 OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDARA</medicinalproduct>
        <drugauthorizationnumb>20723</drugauthorizationnumb>
        <drugdosagetext>TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>CONDYLOMA ACUMINATUM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528793-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A20043615</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAXOLOL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>19507</drugauthorizationnumb>
        <drugdosagetext>10 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040214</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528794-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BRO-008010</companynumb>
    <primarysource></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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IOPAMIDOL</medicinalproduct>
        <drugauthorizationnumb>18735</drugauthorizationnumb>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IOPAMIDOL</medicinalproduct>
        <drugauthorizationnumb>18735</drugauthorizationnumb>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528795-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02100-JPN-04-0306</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugauthorizationnumb>20863</drugauthorizationnumb>
        <drugdosagetext>ONE OF 200 MG OR 81 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUDILAST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URAPIDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIASTASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528796-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BRO-007856</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSPASM CORONARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTRAST MEDIA REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA OF LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRIDOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IOPAMIDOL-300</medicinalproduct>
        <drugauthorizationnumb>18735</drugauthorizationnumb>
        <drugdosagetext>100 ML IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>807</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IOPAMIDOL-300</medicinalproduct>
        <drugauthorizationnumb>18735</drugauthorizationnumb>
        <drugdosagetext>100 ML IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMANGIOMA OF LIVER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>807</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NELBON (NITRAZEPAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528797-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BRO-007728</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN M INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE VASOVAGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IOPAMIDOL-300</medicinalproduct>
        <drugauthorizationnumb>18735</drugauthorizationnumb>
        <drugdosagetext>0.5 ML IR  A FEW SECS</drugdosagetext>
        <drugindication>ARTHROGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLOCAINE HYDROCHLORIDE, (LIDOCAINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTANCYL, (PREDNISOLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIGPRIV</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528798-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RB-1138-2004</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugauthorizationnumb>20732</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528799-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20010215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0140463A</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENERGY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528800-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RB-1140-2004</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugauthorizationnumb>20732</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528801-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RB-1142-2004</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugauthorizationnumb>20732</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528802-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0411641A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLONIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010130</drugenddate>
        <drugtreatmentduration>239</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL PM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PONSTEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORINAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528803-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031031</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0432983A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44.5</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY ASPHYXIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970214</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528804-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040402</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0506346A</companynumb>
    <primarysource>
      <qualification>4</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528805-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0528109A</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugbatchnumb>4D015</drugbatchnumb>
        <drugdosagetext>2SPR TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE AND PSEUDOEPHEDRINE SULFATE</medicinalproduct>
      </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>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528806-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0530819A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>1050MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528807-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0531192A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSOLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528808-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0532877A</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040109</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMALE HORMONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLADDER DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>34U PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DRUG</medicinalproduct>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528809-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0534152A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528810-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0534336A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.2</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528811-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0534350A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528812-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0536962A</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA OF THE CERVIX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA OF THE CERVIX</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041209</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN LOWER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN LOWER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528813-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537236A</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528814-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537260A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUELICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMELOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528815-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537262A</companynumb>
    <primarysource>
      <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>PAXIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528816-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537276A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528817-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537316A</companynumb>
    <primarysource>
      <qualification>5</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>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528818-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537468A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528819-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0337888A</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>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528820-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0347537A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATINE PHOSPHOKINASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPIDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FASTIC</medicinalproduct>
        <drugdosagetext>90MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXAN</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528821-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0347804A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>112</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHING'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY HYPERALDOSTERONISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTIDE DISKUS</medicinalproduct>
        <drugdosagetext>200MCG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIPHYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528822-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0349432A</companynumb>
    <primarysource>
      <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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PIGMENTATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040302</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040220</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOCRIN</medicinalproduct>
        <drugdosagetext>3CAP PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040221</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528823-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0357463A</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528824-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0358408A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELITREX</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041003</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugdosagetext>500MG SIX TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABNORMAL FAECES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABNORMAL FAECES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOXID</medicinalproduct>
        <drugdosagetext>600MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABNORMAL FAECES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OFLOCET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ABNORMAL FAECES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528825-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0359079A</companynumb>
    <primarysource>
      <qualification>5</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>ARTERIAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA OF LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEBRIDAT</medicinalproduct>
        <drugdosagetext>6UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORADRENALINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMPERAN</medicinalproduct>
        <drugdosagetext>3UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLUDACTONE</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SURBRONC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENTEROBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>400MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENTEROBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPNOVEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPHEDRINE SUL CAP</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528826-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>001#1#2004-02337</companynumb>
    <primarysource>
      <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>ASTHENOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXAT</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528827-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0359936A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>35</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040729</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDEX</medicinalproduct>
        <drugdosagetext>1.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INIPOMP</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METEOSPASMYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUPHALAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528828-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0359975A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC URAEMIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCLERODERMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITAZOXANIDE</medicinalproduct>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROENTERITIS CRYPTOSPORIDIAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528829-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0360095A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELZIR</medicinalproduct>
        <drugdosagetext>700MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugdosagetext>80MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528830-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0360262A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD OSMOLARITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KETOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRACTAZIN</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>37.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>URBANYL</medicinalproduct>
        <drugdosagetext>1UNIT TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>1UNIT WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKENAN</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKOR FORT</medicinalproduct>
        <drugdosagetext>2UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORLAX</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPAGULAX</medicinalproduct>
        <drugdosagetext>2UNIT PER DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELOKEN</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT D3</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030424</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528831-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-0323</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>803</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAPTOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANIPLEX</medicinalproduct>
        <drugdosagetext>15MGKD UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528832-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200404621</companynumb>
    <primarysource>
      <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>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
        <drugtreatmentduration>82</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENIVACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528833-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GLAXOSMITHKLINE-B0361828A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF DESPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEARFULNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL DECANOATE</medicinalproduct>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTANE</medicinalproduct>
        <drugindication>RESTLESSNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528834-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GLAXOSMITHKLINE-B0361852A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOOLS WATERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MALARONE</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528835-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RB-1144-2004</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugauthorizationnumb>20732</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528836-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RB-1148-2004</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHORIOAMNIONITIS</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>BUPRENORPHINE HCL</medicinalproduct>
        <drugauthorizationnumb>20732</drugauthorizationnumb>
        <drugdosagetext>6 MG</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528837-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RB-1145-2004</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugauthorizationnumb>20732</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528838-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F01200402712</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KETONURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL TENESMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>(OXALIPLATIN) - SOLUTION - 80 MG/M2</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>80 MG/M2 Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>(FLUOROURACIL) - SOLUTION - 3000 MG/M2</medicinalproduct>
        <drugdosagetext>3000 MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040828</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUGLUCON (GLIBENCLAMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTIROX (LEVOTHYROXINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADOFEN (FLUOXETINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOREA (MEGESTROL ACETATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERMALGIN (PARACETAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYNAMOGEN (ASPARTATE NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528839-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F01200403741</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>(OXALIPLATIN) - SOLUTION - 130 MG/M2</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>243 MG Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>(CAPECITABINE) - TABLET - 1000 MG/M2</medicinalproduct>
        <drugdosagetext>3600 MG (1000 MG/M2 TWICE DAILY FROM DAY 1 TO DAY 15, Q3W)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMCONOR (BISOPROLOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528840-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040917</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A02200402860</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATINE - (OXALIPLATIN) - SOLUTION - 5 MG/ML</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>170 MG OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040804</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATINE - (OXALIPLATIN) - SOLUTION - 5 MG/ML</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>170 MG OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040804</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528841-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A01200404895</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHROPOIESIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION VIRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>20839</drugauthorizationnumb>
        <drugdosagetext>75 MG OD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENA CAVA FILTER INSERTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSACOL (URSODEXYCHOLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORZAAR (LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528842-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE261407DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>18989</drugauthorizationnumb>
        <drugdosagetext>1200-1600MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE (BENDROFLUMETHIAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C (ASCORBIC ACID)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528843-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugdosagetext>200 MG 2-3 PILLS/DAY</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
      </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>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR 50/500</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528844-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F01200403764</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CREPITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN - SOLUTION - 100 MG/M2</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>200 MG Q2W, INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040712</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>3000 MG Q2W, INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040714</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>400 MG Q2W INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040712</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANIDIP (LERCANIDIPNE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528845-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>114.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300 MG PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300 MG PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>?- CONTINOUS PUMP</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528846-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D01200404805</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN - SOLUTION - 85 MG/M2</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>85 MG/M2 Q2W, INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>400 MG/M2 AS IV BOLUS GHEN 600 MG/M2 AS 22 HOURS CONTINUOUS INFUSION D1-D2 Q2W INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SR57746 OR PLACEBO - CAPSULE - 1 MG</medicinalproduct>
        <drugdosagetext>1 MG QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
        <drugtreatmentduration>171</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>200 MG/M2 AS 2 HOURS INFUSION ON D1-D2 Q2W INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528847-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>10 MG DAILY EXCEPT 12 MG Q WED AND SAT  CHRONIC</drugdosagetext>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAZOLAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNAS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528848-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TOR 2004-0034</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CERVIX DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FARESTON</medicinalproduct>
        <drugauthorizationnumb>20497</drugauthorizationnumb>
        <drugdosagetext>40 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>415</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528849-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugdosagetext>0.5 MG Q4 H PRN X2 DOSES</drugdosagetext>
        <drugindication>ABNORMAL BEHAVIOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528850-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>54756/456</companynumb>
    <primarysource></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>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVONELLE (OTC) COATED TABLET</medicinalproduct>
        <drugdosagetext>PER OS</drugdosagetext>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528851-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>127</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugdosagetext>400 MG Q 4 HRS</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>120 MG QD CHRONIC</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAWPALMETTO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528852-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12400AU</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</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>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugdosagetext>IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
        <drugdosagetext>4 MG (4 MG, 4 MG DAILY) PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528853-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugdosagetext>50 MG PO QHS CHRONIC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHIC PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMADEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528854-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-DE-06028GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE (NEVIRAPINE) (NEVIRAPINE)</medicinalproduct>
        <drugauthorizationnumb>20636</drugauthorizationnumb>
        <drugdosagetext>200 MG/D FOR 14 DAYS, FOLLOWED BY 200 MG TWICE DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528855-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-CN-00610CN</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugdosagetext>80 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528856-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>VARIED</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG DAILY CHRONIC</drugdosagetext>
        <drugindication>STENT PLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SURFAK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528857-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-DE-06007GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLACTACIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITOCHONDRIAL CYTOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASTICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLEXES ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE (NEVIRAPINE) (NEVIRAPINE)</medicinalproduct>
        <drugauthorizationnumb>20636</drugauthorizationnumb>
        <drugadministrationroute>015</drugadministrationroute>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE (LAMIVUDINE)</medicinalproduct>
        <drugadministrationroute>015</drugadministrationroute>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINES (BENZODIAZEPINES DERIVATIVES)</medicinalproduct>
        <drugadministrationroute>015</drugadministrationroute>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528858-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPRISONMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL ASSAULT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>1 TAB @ NIGHT ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OFF LABEL USE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>1 TAB @ NIGHT ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528859-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12564BR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugdosagetext>18 MCG (18 MCG, 1 KAI OAD)</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030710</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA 2 (BETA 2 AGONIST)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOIDE (NON-SPECIFIED CORTICOID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528860-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SK-JNJFOC-20041200761</companynumb>
    <primarysource>
      <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>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>4RMKA727</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC FORTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC FORTE</medicinalproduct>
        <drugdosagetext>DICLOFENAC SODIUM 75MG + MISOPROSTOL 0.2MG (2 TABLETS DAILY)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>1 TABLET IN THE MORNING</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugdosagetext>1 TABLET IN THE MORNING</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528861-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20041201061</companynumb>
    <primarysource>
      <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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEGURIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528862-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041201331</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>2ND INFUSION OF REMICADE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528863-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041201551</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HILAR LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</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>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>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>6 DAYS</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528864-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20041201847</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528865-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041106499</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</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>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528866-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20041102763</companynumb>
    <primarysource>
      <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>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMUREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528867-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040606418</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.06</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFUSE LARGE B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528868-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041203824</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HISTOPLASMOSIS DISSEMINATED</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>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugdosagetext>37.5/25 MG</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVLITE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVLITE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugdosagetext>1-2 TABS</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528869-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20040909465</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</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>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528870-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20031204379</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>4RMKA711</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>4RMKA711</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>4RMKA711</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>4RMKA711</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>4RMKA711</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOCAL D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOCAL D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOCAL D</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURICEF</medicinalproduct>
        <drugdosagetext>1 GRAM TWICE A DAY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CELLULITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALICUM</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YOGURT CAPSULES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528871-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041205</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-JNJFOC-20041106158</companynumb>
    <primarysource>
      <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>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>4 INFUSIONS.  2 HOUR INFUSION.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>30-40MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528872-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-DE-03811DE</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIFROL (PRAMIPEXOLE DIHYDROCHLORIDE) (TA)</medicinalproduct>
        <drugauthorizationnumb>20667</drugauthorizationnumb>
        <drugdosagetext>0.36 MG (0.36 MG)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040625</drugenddate>
        <drugtreatmentduration>167</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODURETIK MITE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOMACK 40</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRENDIPIN 20</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIUTENSAT (DYAZIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528873-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_23464_2003</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>ISCHAEMIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugauthorizationnumb>18998</drugauthorizationnumb>
        <drugdosagetext>1.25 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 M Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPUGAN</medicinalproduct>
        <drugdosagetext>80 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELOKEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528874-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TUK2004A00133</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>15 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN (METFORMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528875-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TUK2004A00134</companynumb>
    <primarysource></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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528876-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-122313-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPIRIDE</medicinalproduct>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528877-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2004-0017665</companynumb>
    <primarysource>
      <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>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFDITOREN PIVOXIL (SIMILAR TO NDA 21-222) (CEFDITOREN PIVOXIL) OTHER</medicinalproduct>
        <drugauthorizationnumb>21222</drugauthorizationnumb>
        <drugdosagetext>100 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOPAL-P (PRONASE, ISOPRENALINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL (ALFACALCIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GILBENCLAMIDE (GLIBENCLAMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANATRIL (IMIDAPRIL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL (NICORANDIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528878-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-DE-06008GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL COORDINATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLACTACIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASTICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR SKILLS IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE (NEVIRAPINE)</medicinalproduct>
        <drugauthorizationnumb>20636</drugauthorizationnumb>
        <drugadministrationroute>015</drugadministrationroute>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>015</drugadministrationroute>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE (STAVUDINE)</medicinalproduct>
        <drugadministrationroute>015</drugadministrationroute>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528879-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2004-0017872</companynumb>
    <primarysource>
      <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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFDITOREN PIVOXIL (SIMILAR TO NDA 21-222) (CEFDITOREN PIVOXIL) OTHER</medicinalproduct>
        <drugauthorizationnumb>21222</drugauthorizationnumb>
        <drugdosagetext>100 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528880-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F01200403741</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN SOLUTION 243 MG SOLUTION 130 MG/M2</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040906</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN SOLUTION 243 MG SOLUTION 130 MG/M2</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE TABLET 1800 MG TABLET 1000 MG/M2</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE TABLET 1800 MG TABLET 1000 MG/M2</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENCONCOR (BISOPROLOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528881-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBR-2004-0001380</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAOCULAR MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STARING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>19516</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020903</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528882-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A02200403454</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>20839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528883-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B01200401936</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BORDERLINE OVARIAN TUMOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>(CLOPIDOGREL) - TABLET - 75 MG</medicinalproduct>
        <drugauthorizationnumb>20839</drugauthorizationnumb>
        <drugdosagetext>75 MG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
        <drugtreatmentduration>215</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>(CLOPIDOGREL) - TABLET - 75 MG</medicinalproduct>
        <drugauthorizationnumb>20839</drugauthorizationnumb>
        <drugdosagetext>75 MG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
        <drugtreatmentduration>215</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRISERIN(CLOPAMIDE/ DIHYDROERGOCRISTINE MESILATE/ RESERPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOCTAMID (LORMETAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528884-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEU-2004-0001169</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALLADONE</medicinalproduct>
        <drugauthorizationnumb>21044</drugauthorizationnumb>
        <drugdosagetext>4 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALLADONE</medicinalproduct>
        <drugauthorizationnumb>21044</drugauthorizationnumb>
        <drugdosagetext>4 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALLADONE</medicinalproduct>
        <drugdosagetext>4 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE MALEATE (DOMPERIDONE MALEATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL (MACROGOL, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528885-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A01200404419</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METAMORPHOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>20839</drugauthorizationnumb>
        <drugdosagetext>75 MG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ANGIOPLASTY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>160 MG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SECTRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYSALFA (TERAZOSIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528886-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SEWYE262407DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528887-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE261907DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>75 MG 2X PER 1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC (DICLOFENAC)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528888-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CEL-2004-02101-SLO</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EQUASYM 5MG (METHYLPHENIDATE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>86429</drugauthorizationnumb>
        <drugdosagetext>10MG MORNING, 5MG LUNCHTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528889-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE762806DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOBAC (PIPERACILLIN/TAZOBACTAM INJECTION)</medicinalproduct>
        <drugauthorizationnumb>50684</drugauthorizationnumb>
        <drugdosagetext>4.5 G 3X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>400 MG 3X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GARAMYCIN</medicinalproduct>
        <drugdosagetext>30 MG 2X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIZANIDINE HCL</medicinalproduct>
        <drugdosagetext>3 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>50 MG  4X PER 1 DAY</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAXIPARIN (HEPARIN-FRACTION, CALCIUM SALT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENERVA (THIAMINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECOZYME FORTE (BIOTIN/CALCIUM PANTOTHENATE/CYANOCOBALAMIN/NICOTINAMID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528890-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_25239_2004</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK LEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEVETEN</medicinalproduct>
        <drugauthorizationnumb>20738</drugauthorizationnumb>
        <drugdosagetext>600 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOLSIDOMIN</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528891-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE751603DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORGESTREL AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>16672</drugauthorizationnumb>
        <drugdosagetext>1 TABLET 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSMENORRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANGE-28 (LEVONORGESTREL/ETHINYL ESTRADIOL/INERT, TABLET)</medicinalproduct>
        <drugdosagetext>1 TABLET 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSMENORRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADONA (CARBAZOCHROME SODIUM SULFONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSAMIN (TRANEXAMIC ACID)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528892-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12795241</companynumb>
    <primarysource>
      <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>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
        <drugtreatmentduration>104</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEBEVERINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERSANTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORMEZANONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL-D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-AMILOFRUSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528893-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE712401DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S ADVIL</medicinalproduct>
        <drugauthorizationnumb>20589</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VARICELLA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528894-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_041205355</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>A FEW YEARS</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528895-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104641</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528896-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F01200402965</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN - SOLUTION - 130 MG/M2</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>130 MG/M2 Q3W INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE SOLUTION 1000 MG/M2</medicinalproduct>
        <drugdosagetext>1000 MG/M2 Q3W INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE TARTRATE/PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528897-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041004922</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERMAX</medicinalproduct>
        <drugauthorizationnumb>19385</drugauthorizationnumb>
        <drugdosagetext>50 UG DAY</drugdosagetext>
        <drugindication>NERVOUS SYSTEM DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENESIT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528898-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F01200402424</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.6</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <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 CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCREATININAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN - SOLUTION - 130 MG/M2</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>130 MG/M2 INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE SOLUTION 1000 MG/M2</medicinalproduct>
        <drugdosagetext>1000 MG/M2 Q3W INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE EDISYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE, PRILOCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILITAZEM HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, THIAMINE HYDROCHLO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZONATATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528899-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A03200403700</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugauthorizationnumb>19908</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528900-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004075134</companynumb>
    <primarysource>
      <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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>5 MG (5 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL (OLMESARTAN MEDOXOMIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528901-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M-04-435</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>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>75135</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031024</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528902-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210586</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugdosagetext>1 MG/KG, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528903-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>20042095</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugauthorizationnumb>20075</drugauthorizationnumb>
        <drugdosagetext>524.7 MCG, DAILY,  INTRATHECAL</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528904-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04110124</companynumb>
    <primarysource>
      <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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</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>20031224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528905-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-05753-00</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>XANTHOPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528906-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528907-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>39.4629</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>0.75MG TID GI</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528908-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-07437-01</companynumb>
    <primarysource>
      <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>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTICTAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugdosagetext>10 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTIINE</medicinalproduct>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE</medicinalproduct>
        <drugdosagetext>5 M G BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE</medicinalproduct>
        <drugdosagetext>15 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE</medicinalproduct>
        <drugdosagetext>10 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528909-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MILRONONE</medicinalproduct>
        <drugdosagetext>400 MCG</drugdosagetext>
        <drugindication>CONGESTIVE CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528910-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SUSI-2004-00840</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>75948</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528911-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugbatchnumb>403173</drugbatchnumb>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528912-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SUSI-2004-00836</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528913-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>10 MG ONCE DAILY, ORALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528914-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004087627</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6996</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20919</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>AGGRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20919</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528915-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104252</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLONIC CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>300 MG (300 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>300 MG (300 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB (CELECOXIB)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528916-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004089717</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL FLUCTUATING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>8762</drugauthorizationnumb>
        <drugdosagetext>(100 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19680101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528917-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104806</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.5547</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAMILY STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMOKER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugauthorizationnumb>19835</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN (VALSARTAN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528918-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184421</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528919-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184499</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528920-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0412108806</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528921-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SUSI-2004-00839</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>75948</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COCAINE (COCAINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPIOID ()</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528922-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SUSI-2004-00837</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>75948</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528923-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SUSI-2004-00841</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>75948</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE (QUETIAPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528924-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SUSI-2004-00842</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>75948</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528925-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SUSI-2004-00843</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE EXTENDED-RELEASE (CARBAMAZEPINE) CAPSULE XR</medicinalproduct>
        <drugauthorizationnumb>75948</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528926-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410605BFR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>130</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOR (ACARBOSE)</medicinalproduct>
        <drugauthorizationnumb>20482</drugauthorizationnumb>
        <drugdosagetext>150 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>300 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EUPRESSYL (URAPIDIL)</medicinalproduct>
        <drugdosagetext>120 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>50 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>30 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528927-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410610BYL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugauthorizationnumb>20198</drugauthorizationnumb>
        <drugdosagetext>20 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>1 MG, QD, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>1 MG, QD, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>1 MG, QD, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TSUMURA SHOU SEI RYUTO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENIRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVAMYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARAMIDIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRYPTANOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528928-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410663BYL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugauthorizationnumb>20198</drugauthorizationnumb>
        <drugdosagetext>520 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugdosagetext>52 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TANATRIL (IMIDAPRIL HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>170 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDOMET</medicinalproduct>
        <drugdosagetext>13.5 G, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041204</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528929-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410973BVD</companynumb>
    <primarysource></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>ANEURYSM RUPTURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENURESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXB66G1</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040912</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528930-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200411038BVD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>400 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528931-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413008GDS</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>19537</drugauthorizationnumb>
        <drugdosagetext>500 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYELONEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528932-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410661BYL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANSPORIN T (CEFOTIAM HEXETIL HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528933-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413312GDS</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugauthorizationnumb>20499</drugauthorizationnumb>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528934-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413354GDS</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSAZID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528935-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-UKI-07898-01</companynumb>
    <primarysource>
      <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>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRALEX (ESCITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528936-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>15553</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.514</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>89384</drugauthorizationnumb>
        <drugdosagetext>320 MG OTHER</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040818</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528937-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>15702</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6996</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>89384</drugauthorizationnumb>
        <drugdosagetext>360MG OTHER</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040413</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528938-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>15694</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.8133</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>89384</drugauthorizationnumb>
        <drugdosagetext>304 MG</drugdosagetext>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040721</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528939-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0411GBR00185</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAB EZETIMIBE (+) SIMVASTATIN 10/40 MG</medicinalproduct>
        <drugauthorizationnumb>21687</drugauthorizationnumb>
        <drugdosagetext>10/40 MG/DAILY/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AORTIC STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528940-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0358187A</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD STEM CELL HARVEST FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>14691</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILGRASTIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528941-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20040603867</companynumb>
    <primarysource>
      <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>INDUCED LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugdosagetext>8 G, 1 IN 1 TOTAL</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528942-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0358184A</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 STEM CELL HARVEST FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>14691</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILGRASTIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528943-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20041201370</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL ABNORMALITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTALFEBAL (IBUPROFEN) SUSPENSION</medicinalproduct>
        <drugauthorizationnumb>19842</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTALFEBAL (IBUPROFEN) SUSPENSION</medicinalproduct>
        <drugauthorizationnumb>19842</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528944-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20040901792</companynumb>
    <primarysource>
      <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>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPILIM (VALPROATE SODIUM)</medicinalproduct>
        <drugdosagetext>6 G, 1 IN 1 TOTAL</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528945-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0410DEU00025</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugauthorizationnumb>21042</drugauthorizationnumb>
        <drugdosagetext>25 MG//DAILY/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE (+) RAMIPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528946-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0358183A</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD STEM CELL HARVEST FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN (FORMUATION UNKNOWN) (MELPHALAN)</medicinalproduct>
        <drugauthorizationnumb>14691</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILGRASTIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528947-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0358297A</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugauthorizationnumb>18473</drugauthorizationnumb>
        <drugdosagetext>5 MG/ TWELVE TIMES PER DAY /</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE+OXYGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL SULPHATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528948-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0358181A</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD STEM CELL HARVEST FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>14691</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILGRASTIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528949-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A01200402647</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>130 MG/M2 OTHER INTRAVENOUS NOS A FEW MINS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAPANOL (MORPHINE SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528950-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BRO-007968</companynumb>
    <primarysource></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>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTRAST MEDIA REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IOPAMIDOL</medicinalproduct>
        <drugauthorizationnumb>18735</drugauthorizationnumb>
        <drugdosagetext>100 ML IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>807</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IOPAMIDOL</medicinalproduct>
        <drugauthorizationnumb>18735</drugauthorizationnumb>
        <drugdosagetext>100 ML IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>807</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528951-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0358180A</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD STEM CELL HARVEST FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOPOIETIC STEM CELL MOBILISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>14691</drugauthorizationnumb>
        <drugdosagetext>SEE DOSAGE TEXT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILGRASTIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528952-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02100-JPN-04-0306</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugauthorizationnumb>20863</drugauthorizationnumb>
        <drugdosagetext>ONE OF 200 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUDILAST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URAPIDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIASTASE COMBINED DRUG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528953-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0358179A</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD STEM CELL HARVEST FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOPOIETIC STEM CELL MOBILISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>14691</drugauthorizationnumb>
        <drugdosagetext>SEE DOSAGE TEXT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>INTRVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528954-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0406GBR00245</companynumb>
    <primarysource></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>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugauthorizationnumb>21042</drugauthorizationnumb>
        <drugdosagetext>25 MG/DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040527</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528955-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0358176A</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD STEM CELL HARVEST FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>14691</drugauthorizationnumb>
        <drugdosagetext>SEE DOSAGE TEXT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528956-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0358177A</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD STEM CELL HARVEST FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>14691</drugauthorizationnumb>
        <drugdosagetext>SEE DOSAGE TEXT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILGRASTIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528957-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0411USA03492</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BILE DUCT CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>20386</drugauthorizationnumb>
        <drugdosagetext>25 MG DAILY; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
        <drugtreatmentduration>1187</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528958-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0411USA03313</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugauthorizationnumb>11664</drugauthorizationnumb>
        <drugdosagetext>8 MG/UNK; PO (SEE IMAGE)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugauthorizationnumb>11664</drugauthorizationnumb>
        <drugdosagetext>8 MG/UNK; PO (SEE IMAGE)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugauthorizationnumb>11664</drugauthorizationnumb>
        <drugdosagetext>8 MG/UNK; PO (SEE IMAGE)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAP TEMOZOLOMIDE</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTROCYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528959-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0358690A</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA MACROCYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCADIAN RHYTHM SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugauthorizationnumb>16860</drugauthorizationnumb>
        <drugdosagetext>300 MG/ TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528960-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-00861</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <reaction>
        <reactionmeddrapt>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.50 MG/M2, UNK; INTRAVENOUS (SEE IMAGE)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.50 MG/M2, UNK; INTRAVENOUS (SEE IMAGE)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528961-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-00876</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXANTHEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NODULE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.6 MG, 2/WEEK; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVOBAN (TROPISETRON HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528962-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>K200401734</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREFEST (ESTRADIOL, NORGESTIMATE) TABLET</medicinalproduct>
        <drugauthorizationnumb>21040</drugauthorizationnumb>
        <drugdosagetext>1 TABLET, QD; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528963-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>K200401548</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>19901</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD IN THE MORNING; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040828</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugdosagetext>150 MG, QD; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040828</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTZAAR (HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM) TABLET, 1U</medicinalproduct>
        <drugdosagetext>1 U, QD; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040828</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMINE ^MERCK^ (METFORMIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYTONS (CLODRONATE DISODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX ^ASTRAZENECA^ (ANASTROZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECTOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SMECTA ^DAE WOONG^ (SMECTITE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATESTAL (LOPERAMIDE OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINUTREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON (GLIBENCLAMIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528964-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0358189A</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 STEM CELL HARVEST FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AKERAN (FORMULATION UNKNOWN) (MELPHALAN)</medicinalproduct>
        <drugauthorizationnumb>14691</drugauthorizationnumb>
        <drugdosagetext>SEE DOSAGE TEXT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILGRASTIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528965-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>K200401826</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>19901</drugauthorizationnumb>
        <drugdosagetext>1.25 MG, QD; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORBENINE (CLOXACILLIN SODIUM) 4G</medicinalproduct>
        <drugdosagetext>4G, QD; UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORECORMON ^BOEHRINGER MANNHEIM (EPOETIN BETA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGELINE (IMMUNOGLOBULIN HUMAN NORMAL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAYEXALATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528966-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>003548</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAC</medicinalproduct>
        <drugauthorizationnumb>20186</drugauthorizationnumb>
        <drugdosagetext>1.00 UNK, QD,</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25.00 MG, 2/WEEK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>50.00 MG, QD; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5.00 MG, QD; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugdosagetext>5.00 MG, BID; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE (CALCIUM CARBONATE)</medicinalproduct>
        <drugdosagetext>UNK, QD,</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20.00 MG, QD;</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugdosagetext>20.00 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>70.00 MG, 1/WEEK,</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAHISTINE MESILATE (BETAHISTINE MESILATE)</medicinalproduct>
        <drugdosagetext>12.00 MG, BID, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TINNITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528967-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANAPROX</medicinalproduct>
        <drugdosagetext>550MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANAPROX</medicinalproduct>
        <drugdosagetext>550MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>7.5 MG BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528968-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102746</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN (1 IN 1 D), UNKNOWN</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528969-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20021201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101159</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>20571</drugauthorizationnumb>
        <drugdosagetext>90 MG (D1, D8, D15, D22 EVERY SIX WEEKS), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL (DOCETAXEL)</medicinalproduct>
        <drugdosagetext>50 MG (D1, D8, D15, D22 EVERY SIX WEEKS); INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEKOVIT CA (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANEXAMIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528970-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUN SHOT WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugdosagetext>25/100MG  4X/DAY</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugindication>SPINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugindication>SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040722</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528971-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004080055</companynumb>
    <primarysource>
      <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>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETIRIZINE (TABLETS) (CETIRIZINE)</medicinalproduct>
        <drugauthorizationnumb>19835</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>1 GRAM (1 GRAM, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYME DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030918</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528972-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004076680</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN (VALSARTAN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528973-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugbatchnumb>C 300952</drugbatchnumb>
        <drugdosagetext>1 DAILY</drugdosagetext>
        <drugindication>BACK DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528974-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004093436</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <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>20702</drugauthorizationnumb>
        <drugdosagetext>(10 MG, UNKNOWN), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIP/TAZO (PIPERACILLIN SODIUM, TAZOBACTAM SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METCLOPRAMIDE (METOCLOPRAMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL (CLOPIDOGREL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528975-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugbatchnumb>15735</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528976-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103580</companynumb>
    <primarysource>
      <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>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHIC PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528977-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SP-2004-001953</companynumb>
    <primarysource>
      <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 PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOTUM 10 MG</medicinalproduct>
        <drugauthorizationnumb>21286</drugauthorizationnumb>
        <drugdosagetext>10 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOTUM 10 MG</medicinalproduct>
        <drugdosagetext>10 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528978-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>100 MGM BID</drugdosagetext>
        <drugindication>POLYCYSTIC OVARIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528979-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-0007815</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS FOCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRICITABINE (EMTRICITABINE)</medicinalproduct>
        <drugauthorizationnumb>21500</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1 IN 48 HR, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE (TENOFOVIR DISOPROXIL FUMARATE)</medicinalproduct>
        <drugdosagetext>300 MG, 1 IN 48 HR, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SQV (SQUINAVIR)</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RTV(RITONAVIR)</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE(LAMIVUDINE)</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528980-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.4619</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528981-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>1 PR DAY</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>1 PR. DAY</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528982-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>0.25 - 0.5 MG, BID, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SELF INJURIOUS BEHAVIOUR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528983-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020325</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0263844A</companynumb>
    <primarysource>
      <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528984-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0271127A</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528985-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20021010</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0282272A</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJACULATION FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTRIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF ESTEEM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-INJURIOUS IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERBAL ABUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528986-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20021114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0285353A</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528987-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0301665A</companynumb>
    <primarysource>
      <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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL ASSAULT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-INJURIOUS IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVONORGESTREL AND ETHINYL ESTRADIOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528988-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040709</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0338535A</companynumb>
    <primarysource>
      <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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERBAL ABUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528989-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040803</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0342239A</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528990-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359407A</companynumb>
    <primarysource>
      <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>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528991-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359409A</companynumb>
    <primarysource>
      <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>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528992-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359410A</companynumb>
    <primarysource>
      <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>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528993-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359411A</companynumb>
    <primarysource>
      <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>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528994-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359413A</companynumb>
    <primarysource>
      <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>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528995-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <primarysource>
      <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>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528996-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359415A</companynumb>
    <primarysource>
      <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>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528997-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
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    <primarysource>
      <qualification>4</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528998-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
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    <primarysource>
      <qualification>4</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4528999-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
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    <transmissiondateformat>102</transmissiondateformat>
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      <qualification>4</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
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    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
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        <drugcharacterization>1</drugcharacterization>
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    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
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    <receiver></receiver>
    <patient>
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        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
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    <transmissiondateformat>102</transmissiondateformat>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
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        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>4529130-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
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    <transmissiondateformat>102</transmissiondateformat>
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      <qualification>4</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
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        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
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    <safetyreportid>4529132-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
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        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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    <safetyreportid>4529133-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
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      <qualification>4</qualification>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
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    <safetyreportid>4529134-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
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    <companynumb>2004-00239</companynumb>
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      <qualification>1</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>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AMYLOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC AMYLOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PULMONARY FUNCTION TEST DECREASED</reactionmeddrapt>
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        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
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        <drugindication>MULTIPLE MYELOMA</drugindication>
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        <drugstartdate>20040419</drugstartdate>
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  <safetyreport>
    <safetyreportid>4529135-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedateformat>102</receivedateformat>
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    <companynumb>2004100145</companynumb>
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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>HYPERTENSIVE CRISIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
        <drugauthorizationnumb>18154</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, SINGLE INTERVAL:  DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4529136-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
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    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
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    <primarysource>
      <qualification>1</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>DYSPNOEA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>EPIGLOTTIC OEDEMA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANDIDIASIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SETRALINE (SERTRALINE)</medicinalproduct>
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        <drugindication>DEPRESSION</drugindication>
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        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICONAZOLE NITRATE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
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    <safetyreportid>4529137-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
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    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
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    <primarysource>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
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        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (100 MG, 2 IN 1 D), ORAL</drugdosagetext>
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        <drugindication>TENDONITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE (CODEINE)</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL (ERGOCALCIFEROL)</medicinalproduct>
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    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedate>20041214</receivedate>
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    <companynumb>2004104367</companynumb>
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      <qualification>3</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>
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        <reactionmeddrapt>BIOPSY BONE MARROW ABNORMAL</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>SKIN DESQUAMATION</reactionmeddrapt>
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        <drugcharacterization>1</drugcharacterization>
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        <drugadministrationroute>048</drugadministrationroute>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
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    <safetyreportid>4529139-7</safetyreportid>
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    <receivedate>20041214</receivedate>
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      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
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        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR (ATORVASTATIN)</medicinalproduct>
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        <drugindication>MIXED HYPERLIPIDAEMIA</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugcharacterization>1</drugcharacterization>
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        <drugindication>HEART TRANSPLANT</drugindication>
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      <drug>
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        <drugadministrationroute>048</drugadministrationroute>
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        <drugcharacterization>1</drugcharacterization>
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        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM(RISEDRNATE SODIUM)</medicinalproduct>
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        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
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    <safetyreportid>4529140-3</safetyreportid>
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    <transmissiondate>20050328</transmissiondate>
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    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103104</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAINFUL RESPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>20597</drugauthorizationnumb>
        <drugdosagetext>1 DOSE FORM (INTERVAL:  EVERY DAY), OPHTHALMIC</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG (20 MG, INTERVAL:  EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG (20 MG, INTERVAL:  EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPICLONE (ZOPICLONE)</medicinalproduct>
        <drugdosagetext>7.5 MG (7.5 MG, INTERVAL:  EVERY DAY) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUINDIONE (FLUINDIONE)</medicinalproduct>
        <drugdosagetext>20 MG (20 MG, INTERVAL:  EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529141-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420371BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTION INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529142-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004083547</companynumb>
    <primarysource>
      <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>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>8762</drugauthorizationnumb>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040727</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529143-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420409BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102.0593</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, OW, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529144-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106502</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOR 9ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, SINGLE INTERVAL: EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529145-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359639A</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529146-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359640A</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529147-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359641A</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529148-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359642A</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529149-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359643A</companynumb>
    <primarysource>
      <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>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529150-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359644A</companynumb>
    <primarysource>
      <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>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529151-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359645A</companynumb>
    <primarysource>
      <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>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529152-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359646A</companynumb>
    <primarysource>
      <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>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529153-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359647A</companynumb>
    <primarysource>
      <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>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529154-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359790A</companynumb>
    <primarysource>
      <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>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529286-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359791A</companynumb>
    <primarysource>
      <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>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529287-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359792A</companynumb>
    <primarysource>
      <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>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529288-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359793A</companynumb>
    <primarysource>
      <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>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529289-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359794A</companynumb>
    <primarysource>
      <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>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529290-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359795A</companynumb>
    <primarysource>
      <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>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529291-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359796A</companynumb>
    <primarysource>
      <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>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529292-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359797A</companynumb>
    <primarysource>
      <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>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529293-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359798A</companynumb>
    <primarysource>
      <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>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529294-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420434BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529295-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004070502</companynumb>
    <primarysource></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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG , 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLO SUCCINATE (METOPROLOL SUCCINATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529296-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420439BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PENIS DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529297-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420440BWH</companynumb>
    <primarysource></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>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529298-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004079329</companynumb>
    <primarysource>
      <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>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYZINE HCL</medicinalproduct>
        <drugauthorizationnumb>10392</drugauthorizationnumb>
        <drugindication>ALLERGY TO ARTHROPOD BITE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACEBUTOLOL</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529299-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420444BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEOSYNEPHRINE NASAL SPRAY (PHENYLEPHRINE HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>ONCE, NASAL</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529300-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004024467</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, DAILY), UNKNOWN</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529301-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103035</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID SOLUTION, STERILE (LINEZOLID)</medicinalproduct>
        <drugauthorizationnumb>21131</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529302-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040903</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420450BWH</companynumb>
    <primarysource></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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529303-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040903</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420454BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAW PALMETTO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529304-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004237219CA</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D (CALCIUM PHOSPHATE, CALCIUM SODIUM LACTATE, ERG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529305-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105306</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugauthorizationnumb>11856</drugauthorizationnumb>
        <drugdosagetext>5 MG (5 MG, 1 IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN CALCIUM</medicinalproduct>
        <drugdosagetext>0.2 ML (0.1 ML, 2 IN 1 D), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE (INSULIN GLARGINE)</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOXACILLIN SODIUM</medicinalproduct>
        <drugdosagetext>3 GRAM (1 GRAM, 3 IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINOMEL (AMINO ACIDS NOS, CALCIUM CHLORIDE DIHYDRATE, ELECTROLYTES NO</medicinalproduct>
        <drugdosagetext>2L (1 IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PARENTERAL NUTRITION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040618</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529306-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004082246</companynumb>
    <primarysource>
      <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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugauthorizationnumb>19949</drugauthorizationnumb>
        <drugdosagetext>400 MG (1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COCCIDIOIDOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COCCIDIOIDOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COCCIDIOIDOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUGS FOR TREATMENT OF PEPTIC ULCER (DRUGS FOR TREATMENT OF PEPTIC ULC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529307-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420204BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASK</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529308-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004095874</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOUS MEMBRANE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DESQUAMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>50784</drugauthorizationnumb>
        <drugdosagetext>500 MG, (1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOCISTEINE (CARBOCISTEINE)</medicinalproduct>
        <drugdosagetext>1500 MG (500 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TULOBUTEROL HYDROCHLORIDE (TULOBUTEROL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROTIZOLAM (BROTIZOLAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529309-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420205BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-DIARRHEAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529310-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004224039FI</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MUCOSAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>40 MG (40 MG, 1 AS NECESSARY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040714</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529311-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103282</companynumb>
    <primarysource>
      <qualification>1</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>SUDDEN CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELDOX (CAPSULES) (ZIPRASIDONE)</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>160 MG (80 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE (ZOPICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529312-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420248BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.5234</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugdosagetext>20 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </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>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529313-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104224</companynumb>
    <primarysource>
      <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>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA INFECTIOSUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARVOVIRUS B19 SEROLOGY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>900 MG (300 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TROXERUTIN (TROXERUTIN)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugdosagetext>10 MG (10 MG, DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>300 MG (150 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAFFEINE / OPIUM/ PARACETAMOL (CAFFEINE, OPIUM TINCTURE, PARACETAMOL)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040824</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529314-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420253BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE REDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529315-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004092672</companynumb>
    <primarysource>
      <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 INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELDOX (CAPSULES) (ZIPRASIDONE)</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>40 MG (40 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030127</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529316-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101069</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>50670</drugauthorizationnumb>
        <drugdosagetext>500 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529317-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040820</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420298BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.2554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, OW, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugdosagetext>20 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESTINON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529318-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003185978IE</companynumb>
    <primarysource>
      <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>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>21130</drugauthorizationnumb>
        <drugdosagetext>1200 MG (1200 MG, DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SKIN ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOGIRENE (FUROSEMIDE, AMILORIDE HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>1 DF, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPTOPRIL DOROM (CAPTOPRIL)</medicinalproduct>
        <drugdosagetext>1 DF, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DRENOL (HYDROCHLOROTHIAZIDE)</medicinalproduct>
        <drugdosagetext>1 DF, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLEX (CARBINOXAMINE MALEATE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529320-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003020878</companynumb>
    <primarysource>
      <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>BLEPHAROSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEIGE'S SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>10392</drugauthorizationnumb>
        <drugdosagetext>25 MG (1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021230</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529321-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004078837</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOR (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529322-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420309BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529323-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097162</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY SMALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>80 MG (80 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE IIA HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL (PERINDOPRIL)</medicinalproduct>
        <drugdosagetext>2 MG (2 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040617</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529324-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420310BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529325-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105748</companynumb>
    <primarysource></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>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOR (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529326-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEADER ALLERGY (OTC)</medicinalproduct>
        <drugdosagetext>1/DAY 3 DAYS</drugdosagetext>
        <drugindication>SEASONAL ALLERGY</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NULYTELY</medicinalproduct>
        <drugdosagetext>AS LABELED</drugdosagetext>
        <drugindication>BARIUM ENEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NULYTELY</medicinalproduct>
        <drugdosagetext>AS LABELED</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529328-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104327</companynumb>
    <primarysource>
      <qualification>2</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>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>11111</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYOSCINE HBR HYT</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL (ETHANOL)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529329-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420369BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.9874</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEXUAL ACTIVITY INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugdosagetext>30 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529330-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103499</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529331-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200419932BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103.4201</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA-D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAW PALMETTO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529332-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004093945</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>80 MG (80 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL (BISOPROLOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFLOMEDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529333-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200419935BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROPOVITE VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529334-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200419938BWH</companynumb>
    <primarysource>
      <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>EJACULATION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529335-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-614</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529336-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200419942BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTOROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529337-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.1532</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBIDOPA /LEVODOPA (GENERIC)</medicinalproduct>
        <drugdosagetext>25/250 8X DAILY</drugdosagetext>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAROXOLYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KCL TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529338-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-612</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>2.5 MG 2X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529339-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>29941130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP06072</companynumb>
    <primarysource></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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU LOTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LECICARBON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOHRUS TAPE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPSO DAINIPPON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIPHYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYSIO 35</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMEDIN S</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAPEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO MATCH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529340-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040813</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420136BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.5338</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXBAK81</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXBAK81</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXBAK81</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE SA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529341-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>45 MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529342-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0282882-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIDIONE 150MG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19430101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugdosagetext>32/12.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529343-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02354</companynumb>
    <primarysource>
      <qualification>1</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>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES INSIPIDUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INTERSTITIAL EMPHYSEMA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHIAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>250 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHIAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529344-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040813</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420139BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTION INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040812</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529345-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040817</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0271148-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
        <drugtreatmentduration>98</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENICILLAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040512</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIINFLAMMATORY THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529346-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0282737-00</companynumb>
    <primarysource></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>HUMIRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN-FRACTION, SODIUM SALT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFERTILITY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFERTILITY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
        <drugadministrationroute>067</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFERTILITY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFERTILITY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529347-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ABBOTT-04P-083-0282715-01</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANT TISSUE NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL SARCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040623</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODURETIC 5-50</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METILDIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugindication>TACHYCARDIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXASINA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030514</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529348-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05871</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVIX CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VEIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADENOCARCINOMA OF THE CERVIX</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAI-KENCHU-TO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUZEN-TAIHO-TO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FESIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PICIBANIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529349-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420169BWH</companynumb>
    <primarysource></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>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORNIAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529350-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0281648-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</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>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEKOVIT CA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529351-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040810</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ABBOTT-04P-008-0270076-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIBUTRAMINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040805</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOPTON</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529352-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040908</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-04P-020-0272652-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TMC114</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TMC114</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIMETICONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLATULENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROCTITIS HERPES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR HCL</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GALENIC /PARACETAMOL/CODEINE/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOPERICARDITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMOPRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529353-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420171BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529354-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0275435-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COOMBS POSITIVE HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
        <drugtreatmentduration>118</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIBOLONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</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>SIMPLE EYE OINTMENT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEVISE EYE DROPS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529355-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0282677-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.21</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</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>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIINFLAMMATORY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRO PATCH</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529356-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-10436</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugbatchnumb>01AC 023</drugbatchnumb>
        <drugdosagetext>0.5 MG/KG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugbatchnumb>01AC023</drugbatchnumb>
        <drugdosagetext>0.5 MG/KG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugbatchnumb>01AC023</drugbatchnumb>
        <drugdosagetext>1 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KENZEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OROKEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529357-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0282724-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.616</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE ER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METROPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</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>ACURITE</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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</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>CALCITONIN-SALMON</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529358-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420178BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXBAKD1</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERELAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529359-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-04P-087-0282714-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITH</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040409</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040409</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL XINAFOATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERRAPEPTASE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMHEXINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGESTIVE ENZYME PREPARATIONS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DECREASED APPETITE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040405</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529360-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030828</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-03P-167-0231243-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOMALY OF EXTERNAL EAR CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL FLAT FEET</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL NOSE MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGRAPHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL DYSMORPHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL VALPROATE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEARNING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PECTUS EXCAVATUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHALANGEAL HYPOPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>READING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER DEVELOPMENTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERNUMERARY NIPPLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIGABATRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529361-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420203BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529362-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>0400046EN0020P</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>27</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLOSSAL NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IIIRD NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCASPAR</medicinalproduct>
        <drugdosagetext>2500 IU/M2 Q14D</drugdosagetext>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugdosagetext>2 MG/M2 Q7D</drugdosagetext>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>6 MG/M2 DAYS 1 AND 15</drugdosagetext>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugdosagetext>1 MG/KG</drugdosagetext>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040803</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529363-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
        <drugdosagetext>50 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529364-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02397</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugdosagetext>16 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLODIL - SLOW RELEASE</medicinalproduct>
        <drugdosagetext>5 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KREDEX</medicinalproduct>
        <drugdosagetext>12.5 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KREDEX</medicinalproduct>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugdosagetext>40 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORVASAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529365-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-04P-020-0282847-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHORIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUDGEMENT IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERIDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERWEIGHT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERIDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXCARBAZEPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040814</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529366-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0282559-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.928</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529368-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0264142-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.112</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOOT AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUNISAL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</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>HYDROCODONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529369-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040906</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0272647-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
        <drugtreatmentduration>120</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugdosagetext>30/500</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOSULEPIN</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN INJECTION, BIPHASIC</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA (COMMERCIAL)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040517</drugenddate>
        <drugtreatmentduration>157</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugindication>TUBERCULOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040422</drugenddate>
        <drugtreatmentduration>275</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE HCL</medicinalproduct>
        <drugindication>TUBERCULOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040422</drugenddate>
        <drugtreatmentduration>275</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529370-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0282800-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529371-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200419737BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>NAV</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, OW, ORAL, SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>NAV</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, OW, ORAL, SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRESSTABS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C</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>GLUCOSAMINE CHONDROITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKGO BILOBA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529373-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200419744BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>NAV</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>5 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529374-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24517</companynumb>
    <primarysource></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>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISOMY 13</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>19726</drugauthorizationnumb>
        <drugdosagetext>3.6 MG MONTH SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529375-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02427</companynumb>
    <primarysource></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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugdosagetext>1.2 ML ONCE SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529376-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200419803BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.9874</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HANGOVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>NAV</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529377-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW23446</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>127.0072</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEXPECTED THERAPEUTIC DRUG EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529378-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040806</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200419817BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529379-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP06152</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>33.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>19627</drugauthorizationnumb>
        <drugdosagetext>1% DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529380-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040805</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200419822BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXB9541</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529381-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24697</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529382-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP06149</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529383-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040806</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200419834BWH</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>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529384-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP06166</companynumb>
    <primarysource>
      <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>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529385-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040805</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200419843BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTION INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>NAV</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DISTURBANCE IN SEXUAL AROUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529386-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040807</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200419867BWH</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>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>5 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529387-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004JP15885</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.0213</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISUDYNE</medicinalproduct>
        <drugauthorizationnumb>21119</drugauthorizationnumb>
        <drugdosagetext>9.3 MG DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529388-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200419929BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.3993</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>NAV</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529389-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP06165</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529390-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24538</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>NI</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>INCREASED DOSE</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529391-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02689</companynumb>
    <primarysource>
      <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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECTOPIC PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>150 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUSTRAL</medicinalproduct>
        <drugdosagetext>200 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUSTRAL</medicinalproduct>
        <drugdosagetext>200 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529392-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE06654</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>100 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>200 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529393-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP04846</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETHRAL STRICTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>20578</drugauthorizationnumb>
        <drugdosagetext>10.8 MG Q3MO SQ</drugdosagetext>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040226</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529394-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugbatchnumb>C401320</drugbatchnumb>
        <drugdosagetext>10 MG, MOUTH</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529395-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02224</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugdosagetext>20 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529396-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.2147</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN STEM HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXERCISE LACK OF</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>10 MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIPIDS INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529397-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004PK02050</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugdosagetext>40 MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMAL</medicinalproduct>
        <drugdosagetext>200 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIRDALUD</medicinalproduct>
        <drugdosagetext>8 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRUFEN</medicinalproduct>
        <drugdosagetext>1200 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOBAC</medicinalproduct>
        <drugdosagetext>13.5 G DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOBAC</medicinalproduct>
        <drugdosagetext>13.5 G DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SKIN NECROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugdosagetext>160 MG DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugdosagetext>160 MG DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SKIN NECROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAXIPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENERVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECOZYME FORTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529398-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.5547</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>PAIN</drugdosagetext>
        <drugindication>INFLAMMATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>PAIN</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529399-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugbatchnumb>X200652</drugbatchnumb>
        <drugdosagetext>ONE PO QD OU</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPINE</medicinalproduct>
        <drugdosagetext>ONE GTT OU QD</drugdosagetext>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM A-D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529400-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>6011684</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL GENERICS (TABLETS) (ENALAPRIL)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL GENERICS (TABLETS) (ENALAPRIL)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>...</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529401-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105200</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIMENHYDRINATE (DIMENHYDRINATE)</medicinalproduct>
        <drugdosagetext>50 MG TWICE DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIZZINESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL (ENALAPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529402-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1728</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>75963</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529403-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2004LT00481</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFUROXIME 'BIOCHEMIE' (NGX) (CEFUROXIME)</medicinalproduct>
        <drugauthorizationnumb>65126</drugauthorizationnumb>
        <drugdosagetext>4.5 G/DAY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOCARDITIS STAPHYLOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529404-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP000911</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TALIPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE HCL</medicinalproduct>
        <drugauthorizationnumb>74680</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERMETHRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLUENZA VACCIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BELCOMETASONE DIPROPIONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529405-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>1000MG/M2 DAYS 1,8,15</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILUADID PCA PUMP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529406-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>AUC 6   Q21D</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>75 MG/M2</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529407-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>003731</companynumb>
    <primarysource>
      <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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000613</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529408-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILD ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>40 MG 1 1/2 QD</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>40 MG 1 1/2 QD</drugdosagetext>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529409-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>003729</companynumb>
    <primarysource>
      <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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529410-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529411-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>003727</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>40159</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529412-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.3993</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>100 MG IV 1X WK  III OTHER</drugdosagetext>
        <drugindication>COMPLEX PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>100 MG IV 1X WK  III OTHER</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529413-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420518BWH</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>LEVITRA</medicinalproduct>
        <drugbatchnumb>NAV</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529414-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>PREDNISOLONE ACETATE</medicinalproduct>
        <drugindication>MACULAR OEDEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529415-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16646</companynumb>
    <primarysource>
      <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>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>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY OCCULT BLOOD POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>125 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
        <drugtreatmentduration>31680</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529416-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420526BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTION INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>NAV</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529417-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12141</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORGARD</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugindication>GASTROINTESTINAL MOTILITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL MOTILITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529418-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13189</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529419-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040506</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US05077</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL FAECES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY COLON ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLECTOMY PARTIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONOSCOPY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABDOMEN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL OCCULT BLOOD POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOLVULUS OF BOWEL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040505</drugenddate>
        <drugtreatmentduration>12960</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>4 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLORAZEPATE DIPOTASSIUM</medicinalproduct>
        <drugdosagetext>15 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>25 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE</medicinalproduct>
        <drugdosagetext>5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
        <drugdosagetext>15 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529420-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040911</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420529BWH</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>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529421-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16643</companynumb>
    <primarysource>
      <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>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>125 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
        <drugtreatmentduration>23040</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529422-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12910</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHONCHI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugdosagetext>2 PUFFS/ Q4H</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE</medicinalproduct>
        <drugdosagetext>260 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
        <drugdosagetext>20 MEQ, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugdosagetext>1 PUFF BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.25 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugdosagetext>220 MCG/BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugdosagetext>1.25 MG, Q6H</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>300 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
        <drugdosagetext>500MG Q6H PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529423-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420534BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>NAV</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLENDIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529424-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040225</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004SE02640</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 GENERALISED EXANTHEMATOUS PUSTULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH SCALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>250 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031013</drugenddate>
        <drugtreatmentduration>41760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APOZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRONAXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529425-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420535BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98.8842</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>NAV</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529426-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03646</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</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>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRACTAL</medicinalproduct>
        <drugindication>LIPID METABOLISM DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RELVENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ART 50</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMACOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INIPOMP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
        <drugdosagetext>1 MG, DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529427-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420537BWH</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>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529428-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1003126</companynumb>
    <primarysource></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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>100 MG TID AND 200MG Q HS, THEN 100MG, QID; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529429-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420544BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.2554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG ; 20 MG  : TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG ; 20 MG  : TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529430-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420552BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>NAV</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROZALAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529431-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1003130</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACEBUTOLOL HCL</medicinalproduct>
        <drugbatchnumb>1M027</drugbatchnumb>
        <drugauthorizationnumb>74288</drugauthorizationnumb>
        <drugdosagetext>200 MG BID; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACEBUTOLOL HCL</medicinalproduct>
        <drugbatchnumb>1M027</drugbatchnumb>
        <drugauthorizationnumb>74288</drugauthorizationnumb>
        <drugdosagetext>200 MG BID; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUTALBITAL ACETAMINOPHEN AND CAFFEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE/BENAZEPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529432-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420554BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.2554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXB9581</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>5 MG, OW ; 10 MG, ONCE  : ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXB9581</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>5 MG, OW ; 10 MG, ONCE  : ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXB9581</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>5 MG, OW ; 10 MG, ONCE  : ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529433-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040902</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US09624</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>109</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
      </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>4529434-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420557BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY ALLERGIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugdosagetext>20 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529435-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1003131</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACEBUTOLOL HCL</medicinalproduct>
        <drugbatchnumb>1M0247</drugbatchnumb>
        <drugauthorizationnumb>74288</drugauthorizationnumb>
        <drugdosagetext>200MG, QD; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529436-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1003284</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108.8633</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugauthorizationnumb>75150</drugauthorizationnumb>
        <drugdosagetext>1MG, HS; ORAL</drugdosagetext>
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        <drugindication>PANIC ATTACK</drugindication>
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        <drugstartdate>20040930</drugstartdate>
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        <drugenddate>20041012</drugenddate>
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      <drug>
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        <medicinalproduct>LISINOPRIL</medicinalproduct>
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      <drug>
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        <medicinalproduct>FENTANYL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNK</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGULAR ILETIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGULAR ILETIN</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4529437-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
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    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMOKER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugauthorizationnumb>20165</drugauthorizationnumb>
        <drugdosagetext>TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>EX-SMOKER</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>4529438-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
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    <companynumb>2004S1003558</companynumb>
    <primarysource></primarysource>
    <sender>
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    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
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      <reaction>
        <reactionmeddrapt>CARCINOMA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>300 MG TID; ORAL</drugdosagetext>
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        <drugindication>SCHIZOPHRENIA</drugindication>
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        <drugstartdate>20030925</drugstartdate>
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        <drugenddate>20041128</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINPHEN/TRAMADOL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL/HCTZ</medicinalproduct>
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      <drug>
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        <medicinalproduct>ESTRADIOL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIPRASIDONE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
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    <seriousnesslifethreatening>1</seriousnesslifethreatening>
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    <receivedate>20041214</receivedate>
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    <patient>
      <patientonsetage>51</patientonsetage>
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        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CARDIAC FLUTTER</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
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        <drugcharacterization>1</drugcharacterization>
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        <drugstartdate>19800101</drugstartdate>
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  <safetyreport>
    <safetyreportid>4529440-7</safetyreportid>
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    <receivedateformat>102</receivedateformat>
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      <qualification>4</qualification>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
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    <safetyreportid>4529441-9</safetyreportid>
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    <receiver></receiver>
    <patient>
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    <patient>
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      <reaction>
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      <reaction>
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        <drugcharacterization>1</drugcharacterization>
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    <patient>
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      <reaction>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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    <transmissiondateformat>102</transmissiondateformat>
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        <drugcharacterization>1</drugcharacterization>
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    <safetyreportid>4529495-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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    <safetyreportid>4529496-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
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        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
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        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
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        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
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    <safetyreportid>4529497-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
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      <qualification>4</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>AGGRESSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>4529498-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <qualification>4</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>4529499-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedate>20041216</receivedate>
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    <primarysource>
      <qualification>4</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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    <safetyreportid>4529500-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
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      <qualification>4</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>AGGRESSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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    <safetyreportid>4529501-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <qualification>4</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>4529502-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedate>20041216</receivedate>
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    <primarysource>
      <qualification>4</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>4529503-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
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    <primarysource>
      <qualification>4</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>4529504-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
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    <primarysource>
      <qualification>4</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>4529505-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
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    <receiptdate>20041205</receiptdate>
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    <primarysource>
      <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>
      <patientweight>49.8957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE ANTISEPTIC MOUTHWASH (MENTHOL, METHYL SALICYLATE, EUCALYPTOL</medicinalproduct>
        <drugdosagetext>1/3 OF THE BOTTLE QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL OVERDOSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B-KOMPLEX ^LECIVA^ (CALCIUM PANTOTHENATE, NICOTINAMIDE, PYRIDOXINE HYD</medicinalproduct>
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    <safetyreportid>4529506-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
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    <receiptdate>20040706</receiptdate>
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    <primarysource>
      <qualification>1</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>2</patientsex>
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        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
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        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
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        <drugcharacterization>1</drugcharacterization>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN (METFORMIN)</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
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      <drug>
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        <medicinalproduct>ATENOLOL</medicinalproduct>
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      <drug>
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        <medicinalproduct>CLOPIDOGREL (CLOPIDOGREL)</medicinalproduct>
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      <drug>
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      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRATE (ORGANIC NITRATES)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529507-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105203</companynumb>
    <primarysource>
      <qualification>5</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROLAIDS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529508-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AL001761</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugauthorizationnumb>70581</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529509-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0412FRA00034</companynumb>
    <primarysource>
      <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 RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETROZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOTEROL HYDROBROMIDE AND IPRATROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529510-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1729</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>74949</drugauthorizationnumb>
        <drugdosagetext>300-550MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529511-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041106664</companynumb>
    <primarysource>
      <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>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM A-D</medicinalproduct>
        <drugauthorizationnumb>19860</drugauthorizationnumb>
        <drugdosagetext>1 CAPLET</drugdosagetext>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPTO BISMOL (BISMUTH SUBSALICYLATE) TABLETS</medicinalproduct>
        <drugdosagetext>4 TABLETS</drugdosagetext>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529512-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1706</companynumb>
    <primarysource>
      <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>ANAEMIA MACROCYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>74949</drugauthorizationnumb>
        <drugdosagetext>75MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529513-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420731BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENILE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529514-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0409USA01813</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
        <drugtreatmentduration>399</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
        <drugtreatmentduration>399</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529515-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1730</companynumb>
    <primarysource>
      <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>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>74949</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529516-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420733BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTION INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529517-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040900337</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL (ACETAMINOPHEN) LIQUID</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
        <drugdosagetext>500 MG,  3 IN 1 DAY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITPR (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROID (LEVOTHYROID)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529518-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1003562</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>200MG QAM AND 400MG HS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESMOPRESSIN ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXCARBAZEPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-ASTHMATICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529519-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420735BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXBCZ71</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529520-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1736</companynumb>
    <primarysource>
      <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>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>74949</drugauthorizationnumb>
        <drugdosagetext>300MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529521-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420736BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529522-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC20041003217</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>JFM 068</drugbatchnumb>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
        <drugdosagetext>1300 MG, 1 IN 1 DAY, ORAL</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>JFM 068</drugbatchnumb>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
        <drugdosagetext>1300 MG, 1 IN 1 DAY, ORAL</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCYAMINE (HYOSCYAMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529523-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420741BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529524-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01020</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529525-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0282351-00</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>18132</drugauthorizationnumb>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529527-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0282352-00</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>18132</drugauthorizationnumb>
        <drugdosagetext>CONTINUOUS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529528-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041103665</companynumb>
    <primarysource>
      <qualification>1</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>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM POOR R-WAVE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QRS COMPLEX PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
        <drugdosagetext>650 MG Q4H PRN</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>2.5 MG, 1 IN 4 HOUR, INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugdosagetext>Q6H</drugdosagetext>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugdosagetext>1 G, 1 IN 1 DAYM INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BCG VACCINE (BCG VACCINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZMACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN (MULTIVITAMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugdosagetext>400 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529529-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420747BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.3273</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXB9551</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TIW, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529530-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA01730</companynumb>
    <primarysource>
      <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>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITTING OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PALPITATIONS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529531-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01143</companynumb>
    <primarysource>
      <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>DYSPHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXALT-MLT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUS HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041207</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529532-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0282353-00</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>18132</drugauthorizationnumb>
        <drugdosagetext>CONTINUOUS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529533-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01021</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529534-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0282354-00</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>18132</drugauthorizationnumb>
        <drugdosagetext>CONTINUOUS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529535-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420748BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529536-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0282355-00</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA SUPRAVENTRICULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>18132</drugauthorizationnumb>
        <drugdosagetext>CONTINUOUS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529537-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01570</companynumb>
    <primarysource>
      <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>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRO-DUR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529538-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420760BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529539-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030915</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0309FRA00056</companynumb>
    <primarysource>
      <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>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOPTIC</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529540-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040903</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040902429</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL 8 HOUR EXTENDED RELEASE (ACETAMINOPHEN) GELTABS</medicinalproduct>
        <drugbatchnumb>HDM185</drugbatchnumb>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
        <drugdosagetext>650 MG, 1 IN 1 DAY</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL 8 HOUR EXTENDED RELEASE (ACETAMINOPHEN) GELTABS</medicinalproduct>
        <drugbatchnumb>HDM185</drugbatchnumb>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
        <drugdosagetext>650 MG, 1 IN 1 DAY</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529541-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01049</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529542-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210217</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529543-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA02228</companynumb>
    <primarysource>
      <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>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETRIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529544-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420764BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041002</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529545-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01086</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529546-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0412GBR00092</companynumb>
    <primarysource>
      <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>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529547-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210896</companynumb>
    <primarysource>
      <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>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugdosagetext>375 MG/M2, Q28D, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENASENSE</medicinalproduct>
        <drugdosagetext>3 MG/KG, Q28D, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>25 MG/M2, QDX3D/28DC</drugdosagetext>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529548-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0411GBR00177</companynumb>
    <primarysource>
      <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>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529549-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03970</companynumb>
    <primarysource>
      <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>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529550-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420592BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529551-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0410GBR00084</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529552-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03248</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA-D</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529553-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0410USA50112</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93.8946</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugauthorizationnumb>21042</drugauthorizationnumb>
        <drugdosagetext>25MG/DAILY/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529554-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210672</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugdosagetext>375 MG/M2, 1/WEEK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR (VENLAFAAXINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529555-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA02395</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE ROLLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROVEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASAL CONGESTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529556-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420593BWH</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>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UHEMABARK (HERB)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529557-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420599BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXBKV1</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529558-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0282362-00</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA SUPRAVENTRICULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>18132</drugauthorizationnumb>
        <drugdosagetext>CONTINUOUS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529559-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041222</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0401USA50180</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.8748</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAB ETORICOXIB 90 MG</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugdosagetext>90 MG/DAILY/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAB PLACEBO (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>BID/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINERALS (UNSPECIFIED) (+) VITAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529560-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420619BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529561-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0282363-00</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA SUPRAVENTRICULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>18132</drugauthorizationnumb>
        <drugdosagetext>CONTINUOUS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529562-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040924</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420621BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTION INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529563-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0282365-00</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>18132</drugauthorizationnumb>
        <drugdosagetext>CONTINUOUS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529564-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420665BWH</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>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529565-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>0660141</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.8748</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAB ETORICOXIB 90 MG</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugdosagetext>90 MG/DAILY/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAB PLACEBO</medicinalproduct>
        <drugdosagetext>BID/PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINERALS (UNSPECIFIED) (+) VITAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529566-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01171</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031128</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529567-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0282368-00</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>18132</drugauthorizationnumb>
        <drugdosagetext>CONTINUOUS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529568-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA01811</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529569-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01208</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529571-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030910</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0309USA01194</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529572-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0282369-00</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>18132</drugauthorizationnumb>
        <drugdosagetext>CONTINUOUS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529573-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420680BWH</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>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040926</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529574-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0282378-00</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PHLEBOTHROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>18132</drugauthorizationnumb>
        <drugdosagetext>CONTINUOUS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529575-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</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>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>50 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN VK</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529576-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01314</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NECK INJURY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529577-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420681BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>5 MG, BIW, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529578-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01711</companynumb>
    <primarysource>
      <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529579-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0282349-00</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>18132</drugauthorizationnumb>
        <drugdosagetext>CONTINUOUS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529580-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00656</companynumb>
    <primarysource>
      <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 MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010812</drugenddate>
        <drugtreatmentduration>698</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROPASTE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM FOLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529581-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420728BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.1324</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTION INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIBIDO INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529582-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugbatchnumb>X200652</drugbatchnumb>
        <drugdosagetext>PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529583-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0282350-00</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>18132</drugauthorizationnumb>
        <drugdosagetext>CONTINUOUS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529584-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.1219</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugbatchnumb>X 200652</drugbatchnumb>
        <drugdosagetext>150 MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529587-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE720901DEC04</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANTED LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>4 MG 1X PER 1 DAY, ORAL; 5 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>4 MG 1X PER 1 DAY, ORAL; 5 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIGALL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529588-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.0187</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUS ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529590-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE749003DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NONSPECIFIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529591-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529593-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE720901DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>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>COMPLICATIONS OF TRANSPLANTED LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIGALL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529594-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING PROJECTILE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB 200 MG PFIZER</medicinalproduct>
        <drugdosagetext>200 MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN/CAFFINE/BUTALBITAL (FIORICET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRO-BID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529596-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE768606DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>9.08</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugauthorizationnumb>11689</drugauthorizationnumb>
        <drugdosagetext>50 MG (OVERDOSE AMOUNT), RECTAL</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040313</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529598-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01177</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTERIOR SPINAL ARTERY SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>867</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529599-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugdosagetext>125, 250, 375, 500, 750 MG PO HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABNORMAL BEHAVIOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugdosagetext>125, 250, 375, 500, 750 MG PO HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MOOD SWINGS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529600-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01363</companynumb>
    <primarysource>
      <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>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529601-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0311USA02530</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INGROWING NAIL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE WITHOUT AURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANALGESIC EFFECT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANALGESIC EFFECT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUTALBITAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529602-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE758403DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>18989</drugauthorizationnumb>
        <drugdosagetext>AS NEEDED, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC EFFECT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIPHENESIN (GUAIFENESIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529604-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0282359-00</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA SUPRAVENTRICULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>18132</drugauthorizationnumb>
        <drugdosagetext>CONTINUOUS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529606-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0282360-00</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA SUPRAVENTRICULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>18132</drugauthorizationnumb>
        <drugdosagetext>CONTINUOUS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529607-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040219</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0402USA01452</companynumb>
    <primarysource>
      <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>ACUTE SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS EROSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMATOSIS CYSTOIDES INTESTINALIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021114</drugenddate>
        <drugtreatmentduration>1218</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROPIPATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031114</drugenddate>
        <drugtreatmentduration>3956</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRIXORAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</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>MAGNESIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529608-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONALON</medicinalproduct>
        <drugdosagetext>CREAM APPLIED TO TORSO 2X DAILY FOR 8 CONSEC DAYS</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONALON</medicinalproduct>
        <drugdosagetext>5%, BID, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529609-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0402USA00067</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529610-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0282361-00</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA SUPRAVENTRICULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>18132</drugauthorizationnumb>
        <drugdosagetext>CONTINUOUS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529612-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA00722</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529613-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0410GBR00173</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529614-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>203472</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46.2669</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEEDING TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN C DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN S DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30UG;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>30UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529616-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A03200403701</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOLIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugauthorizationnumb>19908</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL - UNKNOWN - UNIT DOSE : UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529617-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040401</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0404USA00094</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020316</drugenddate>
        <drugtreatmentduration>223</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN-D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EX-SMOKER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORFLEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORFLEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529618-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104153</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL SOFT TISSUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG (1 IN 1 D)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529619-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-028624</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.5</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO SPLEEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECARDRON /NET/ (DEXAMETHASONE SODIUM PHOSPHATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL (METRONIDAZOLE BENZOATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529620-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00433</companynumb>
    <primarysource>
      <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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE AND RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XIPAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529621-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-10813</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.3284</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</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>20030618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </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>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529622-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0407USA01749</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOARSENESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD THICKENING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020128</drugenddate>
        <drugtreatmentduration>292</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUTALBITAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLIDINIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROPIPATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN-D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529623-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00756</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREST SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITUITARY TUMOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA-D</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529624-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040227</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0403USA00007</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC DISORDER WITH AGORAPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOLISTHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020501</drugenddate>
        <drugtreatmentduration>93</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020501</drugenddate>
        <drugtreatmentduration>93</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020401</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020401</drugenddate>
        <drugtreatmentduration>764</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529625-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004094491</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.3597</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>4 MG (4 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS (ASCORBIC ACID, ERGOCALCIFEROL, FOLIC ACID, NICOTINAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON (IRON)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529626-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-035566</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>21037</drugauthorizationnumb>
        <drugdosagetext>16 ML, 1 DOSE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529627-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004215042US</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>20280</drugauthorizationnumb>
        <drugdosagetext>12.6MG WEEKLY</drugdosagetext>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID (ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529628-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-558</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>7.5 MG 1 X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>7.5 MG 1 X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZMACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAW PALMETTO (SERENOA REPENS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINORIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529629-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-465</companynumb>
    <primarysource></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>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>25 MG 1 X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE (INFLIIXIMAB)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529630-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041227</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-198</companynumb>
    <primarysource></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>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>5 MG 1 X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529631-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-036074</companynumb>
    <primarysource>
      <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>BRAIN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 300</medicinalproduct>
        <drugbatchnumb>131182T</drugbatchnumb>
        <drugauthorizationnumb>20220</drugauthorizationnumb>
        <drugdosagetext>140 ML, 1 DOSE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM ABDOMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529632-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA02282</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SOFT TISSUE INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELDANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529633-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-MERCK-0412NOR00026</companynumb>
    <primarysource>
      <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>ANOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040116</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE ACETATE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040112</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE ACETATE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040116</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040112</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040116</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529634-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041010</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00302</companynumb>
    <primarysource>
      <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>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SOFT TISSUE DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529635-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-10803</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</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>20030618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </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>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529636-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA02189</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529637-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-123138-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>20415</drugauthorizationnumb>
        <drugdosagetext>30 G QD</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>45 MG QD</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>0.1 MG, EVERY 8 HOURS</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>0.3 MG TOPICAL, PATCH EVERY 8 HOURS</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529638-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0412AUS00056</companynumb>
    <primarysource>
      <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 FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529639-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00120</companynumb>
    <primarysource>
      <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>COMPARTMENT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
        <drugtreatmentduration>594</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529640-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00122</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OCULAR VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529641-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OSCN-PR-0412S-0355</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>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DNA ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID FACTOR QUANTITATIVE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIC RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugauthorizationnumb>20123</drugauthorizationnumb>
        <drugdosagetext>40 ML, SINGLE DOSE, I.V.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PERIPHERAL VASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529642-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA02624</companynumb>
    <primarysource>
      <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529643-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00111</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040611</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529644-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MERCK-0412CAN00068</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529645-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00930</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529646-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA01401</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529647-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OMPQ-PR-0412L-1421</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugauthorizationnumb>18956</drugauthorizationnumb>
        <drugdosagetext>24 ML, SINGLE DOSE, I.A.</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>ANEURYSM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPAQUE</medicinalproduct>
        <drugdosagetext>SINGLE DOSE, I.A.</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>ANEURYSM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESIPRAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529648-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00779</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529649-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-NOVOPROD-241043</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTRAPID</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOMIX 30 PENFILL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
        <drugtreatmentduration>25920</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>1 DOSE ORAL DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN                               /UNK/</medicinalproduct>
        <drugdosagetext>1 THREE TIMES/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>24480</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>1 DAILY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOMIX 30</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
        <drugtreatmentduration>25920</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529650-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00107</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WHIPLASH INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529651-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00707</companynumb>
    <primarysource>
      <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529652-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OMPQ-PR-0412L-1420</companynumb>
    <primarysource>
      <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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS CORTICAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BRAIN BARRIER DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugauthorizationnumb>18956</drugauthorizationnumb>
        <drugdosagetext>27 ML, SINGLE DOSE, I.A.</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>HEMIPARESIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529653-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00702</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERSANTIN INJ</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529654-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-MERCK-0412NOR00027</companynumb>
    <primarysource>
      <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>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040829</drugenddate>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529655-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00700</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030701</drugenddate>
      </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>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529656-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00750</companynumb>
    <primarysource>
      <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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529657-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00880</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FUNGAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CANDIDIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529658-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00701</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529659-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01074</companynumb>
    <primarysource>
      <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529660-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0407USA00806</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROBLASTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSMEGEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEUROBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000810</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSMEGEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000915</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSMEGEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001006</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEUROBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEUROBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000812</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000917</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001008</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIACIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEUROBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000810</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIACIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000915</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIACIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001006</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529661-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00919</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529662-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-MERCK-0412DNK00005</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALEORID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529663-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00108</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS, CONJUGATED AND MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529664-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420895BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXBAKD1</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529665-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420897BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529667-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420907BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529668-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420910BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EJACULATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXZIL CR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529669-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420912BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.2554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL; SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529670-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041030</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420922BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529671-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420924BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTION INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529672-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420925BWH</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>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529676-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00331</companynumb>
    <primarysource>
      <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>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
        <drugtreatmentduration>177</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL VALERATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLECALCIFEROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529677-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200417898BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.7298</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIPPLE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXBAKC1</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B COMPLEX WITH AMINO ACIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS W/MINERALS/GINSENG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID CARE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529678-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200417950BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTION INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040521</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529679-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040820</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200417959BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.2554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE WITH AURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NARCOTIC THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUPRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529680-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040806</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200417980BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXBB9P1</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXBB9P1</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXBB9P1</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529681-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200418001BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529682-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200418003BWH</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>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529683-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-240936</companynumb>
    <primarysource>
      <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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN N</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529685-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200418005BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>B8591</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529696-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>1781-104</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.7507</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE IMMEASURABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE SOLUTION, 20%, 4 ML VIAL</medicinalproduct>
        <drugbatchnumb>4544</drugbatchnumb>
        <drugauthorizationnumb>72547</drugauthorizationnumb>
        <drugdosagetext>600 MG ORALLY ONCE</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMERICAN REGENT INC.</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529697-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210932</companynumb>
    <primarysource>
      <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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB(BEVACIZUMAB) PWDR + SOLVENT,INFUSION SOLN, 100MG</medicinalproduct>
        <drugdosagetext>15 MG/KG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>6 AUC, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>200 MG/M2, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040218</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529699-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101508</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117.9352</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROGAINE</medicinalproduct>
        <drugbatchnumb>18KVK</drugbatchnumb>
        <drugauthorizationnumb>19501</drugauthorizationnumb>
        <drugdosagetext>1 ML BID, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529701-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MK200412-0247-1</companynumb>
    <primarysource>
      <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>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>XANTHOCHROMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE HCL</medicinalproduct>
        <drugauthorizationnumb>40300</drugauthorizationnumb>
        <drugdosagetext>10 MG, TWICE DAILY</drugdosagetext>
        <drugindication>PSYCHOMOTOR HYPERACTIVITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529705-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-05100</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>85162</drugauthorizationnumb>
        <drugdosagetext>10 MG:TIDX4D, BIDX4D, THEN DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZIDE (GLICLAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529709-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0282262-00</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugauthorizationnumb>62911</drugauthorizationnumb>
        <drugdosagetext>1 GM, GIVEN ONCE OVER TEN MINUTES, INTRAVENOUS BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529712-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-08110BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>20636</drugauthorizationnumb>
        <drugdosagetext>400 MG, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDEX EC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529726-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET CR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529727-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529728-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>1 TAB PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529730-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYREM</medicinalproduct>
        <drugdosagetext>X 2 PER NIGHT</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529732-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></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>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529734-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.4619</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>20 MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529736-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>128.368</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>0.9 MG QD</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529739-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117.9352</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugdosagetext>700 MG IV Q24HR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>APPENDICITIS PERFORATED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529852-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-0933</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugdosagetext>DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529861-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041201812</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529862-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041201814</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WARM</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>PREDNISONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529863-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20041201851</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529864-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041201940</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN COLONIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VEIN OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</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>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529865-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041202246</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABUMETONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529866-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041202247</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>INFLAMMATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONNATAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONNATAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONNATAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONNATAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529867-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041202249</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CUTANEOUS LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529868-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041202254</companynumb>
    <primarysource>
      <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>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529869-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041202419</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMYCOSIS</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>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONIPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALAGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELADIL</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYSTANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOCALIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529870-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040801005</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIUM AVIUM COMPLEX 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>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529871-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GDP-0411585</companynumb>
    <primarysource>
      <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>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFFERIN</medicinalproduct>
        <drugbatchnumb>UAP</drugbatchnumb>
        <drugauthorizationnumb>20748</drugauthorizationnumb>
        <drugdosagetext>1 APP QD TP</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529872-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>K200401823</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>30</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDETTE-21</medicinalproduct>
        <drugauthorizationnumb>18668</drugauthorizationnumb>
        <drugdosagetext>1 TABLET, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFUROXIM ^CURASAN^ (CEFUROXIME SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFORTIL (ETILEFRINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529873-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-06434BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugauthorizationnumb>20884</drugauthorizationnumb>
        <drugdosagetext>SEE TEXT (SEE TEXT, 25 MG/200 MG (ONE CAPSULE BID)), PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</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>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529874-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-NOVOPROD-240652</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>MUSCLE ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROFEM</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>14400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529875-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-NOVOPROD-240442</companynumb>
    <primarysource>
      <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>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENZYME ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTUBATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTRAPID</medicinalproduct>
        <drugdosagetext>.05 IU/KG, UNK</drugdosagetext>
        <drugindication>INSULIN TOLERANCE TEST</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529876-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2004A01173</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47.6277</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</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>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAVIK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529877-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-08448BP</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>20636</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040325</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040325</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040325</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529878-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TPA2004A01518</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>127.0072</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugauthorizationnumb>21073</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (POTASSIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529879-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-07238BP</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>465004A</drugbatchnumb>
        <drugauthorizationnumb>20291</drugauthorizationnumb>
        <drugdosagetext>4 PUF (SEE TEXT, 2 PUFFS TWICE DAILY), IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>465004A</drugbatchnumb>
        <drugauthorizationnumb>20291</drugauthorizationnumb>
        <drugdosagetext>4 PUF (SEE TEXT, 2 PUFFS TWICE DAILY), IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529880-6</safetyreportid>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
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    <companynumb>2004-BP-13073BP</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugauthorizationnumb>19085</drugauthorizationnumb>
        <drugdosagetext>72 MCG (18 MCG, 2 PUFFS BID), IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529881-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0282343-00</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>18132</drugauthorizationnumb>
        <drugdosagetext>CONTINUOUS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529882-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
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      <qualification>2</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>18132</drugauthorizationnumb>
        <drugdosagetext>CONTINUOUS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIDS</medicinalproduct>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529883-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
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      <qualification>2</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>18132</drugauthorizationnumb>
        <drugdosagetext>CONTINUOUS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIDS</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>4529884-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
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      <qualification>2</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>18132</drugauthorizationnumb>
        <drugdosagetext>CONTINUOUS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIDS</medicinalproduct>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529885-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
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    <receiptdate>20041129</receiptdate>
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      <qualification>2</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>18132</drugauthorizationnumb>
        <drugdosagetext>CONTINUOUS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIDS</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>4529886-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
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    <receiptdate>20041129</receiptdate>
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    <primarysource>
      <qualification>2</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>18132</drugauthorizationnumb>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529887-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
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      <qualification>4</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>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
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        <drugstartdate>20001004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021202</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>4529888-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
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    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>25800</companynumb>
    <primarysource>
      <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>LOCALISED EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDARA</medicinalproduct>
        <drugauthorizationnumb>20723</drugauthorizationnumb>
        <drugdosagetext>1 SACHET, 3 IN 1 WEEK(S), TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ACTINIC KERATOSIS</drugindication>
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        <drugstartdate>20041013</drugstartdate>
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        <drugenddate>20041116</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4529889-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
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    <receivedate>20041214</receivedate>
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      <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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>M26153</drugbatchnumb>
        <drugdosagetext>150 MG, Q4W</drugdosagetext>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030913</drugstartdate>
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        <drugenddate>20041001</drugenddate>
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  <safetyreport>
    <safetyreportid>4529890-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
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    <companynumb>2004107918</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
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      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-MEDROL</medicinalproduct>
        <drugauthorizationnumb>11757</drugauthorizationnumb>
        <drugdosagetext>EPIDURAL</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
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  <safetyreport>
    <safetyreportid>4529895-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
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        <drugstartdate>20030220</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugindication>KAPOSI'S SARCOMA</drugindication>
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      <drug>
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      <drug>
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        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
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      <drug>
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        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030220</drugstartdate>
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      <drug>
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        <drugstartdate>20030110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030218</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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  <safetyreport>
    <safetyreportid>4529896-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
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    <receiptdate>20041209</receiptdate>
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    <primarysource>
      <qualification>3</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>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugindication>UTERINE CANCER</drugindication>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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  </safetyreport>
  <safetyreport>
    <safetyreportid>4529897-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12789400</companynumb>
    <primarysource>
      <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>ENDOPHTHALMITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPYON</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENACORT-A INJ</medicinalproduct>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040210</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529898-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-04P-020-0281980-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529899-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0282608-00</companynumb>
    <primarysource></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>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
        <drugtreatmentduration>231</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOCOM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529900-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0282798-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMOSOME ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529902-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041008</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-04P-062-0276861-00</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>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</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>PREDNISOLONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>5 PLUS</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRENDIPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529903-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0264935-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERIDIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <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>QUININE SULFATE</medicinalproduct>
        <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>LANSOPRAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 25</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529904-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0282539-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAMORPHINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529905-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106700</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529906-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE745703DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>20216</drugauthorizationnumb>
        <drugdosagetext>ONE-HALF TO ONE FULL APPLICATOR DAILY, DOSE, FREQUENCY, + ROUTE USED 1.1 VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>ATROPHIC VULVOVAGINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529907-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004088739</companynumb>
    <primarysource>
      <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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD HOMOCYSTEINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>40 MG (20 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL HYDROCHLORIDE (VARDENAFIL HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>20 MG (20 MG, 2 IN 1 WK), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529908-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2004-0016540</companynumb>
    <primarysource></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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>20 MG, Q12H</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529909-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2004-0017582</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>W04R1</drugbatchnumb>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>20 MG, BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529910-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0282381-00</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PHLEBOTHROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>18132</drugauthorizationnumb>
        <drugdosagetext>CONTINUOUS, INTRAVEOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529911-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0282383-00</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PHLEBOTHROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>18132</drugauthorizationnumb>
        <drugdosagetext>CONTINUOUS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529912-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103044</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529913-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099632</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZARONTIN SYRUP</medicinalproduct>
        <drugauthorizationnumb>80258</drugauthorizationnumb>
        <drugdosagetext>(0071-2418-23),U-</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529914-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101804</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</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>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529915-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102576</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.3273</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB (CELECOXIB)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLTERODINE TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529916-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040402</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-BRISTOL-MYERS SQUIBB COMPANY-12549903</companynumb>
    <primarysource>
      <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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>INVIRASE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040325</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARAPRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSTANON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529917-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103088</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>20280</drugauthorizationnumb>
        <drugdosagetext>(21.6 MGS PER WEEK), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529918-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101960</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>(100 MG)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE0</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL (FISH OIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAZINE (SESALAZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEFAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529919-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94.3482</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>75 MG, DAILY, MOUTH</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529920-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.9874</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529921-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>INCREASING STRENGTH 1/DAY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529922-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>1 EACH DAY</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529923-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>15 MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TENDONITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>15 MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TENDONITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529924-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529925-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
        <drugdosagetext>DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
        <drugdosagetext>DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SKIN ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529926-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.6173</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>300 MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529927-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200412251BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.7507</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKA-SELTZER PLUS NIGHT-TIME COLD</medicinalproduct>
        <drugbatchnumb>4344MF</drugbatchnumb>
        <drugdosagetext>QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990126</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529928-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106533</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529932-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103296</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PSYCHOLEPTICS (PSYCHOLEPTICS)</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTEHR THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529933-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101615</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTRAINDICATION TO MEDICAL TREATMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
        <drugauthorizationnumb>20931</drugauthorizationnumb>
        <drugdosagetext>2 OR 3 YEARS AGO</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>JOINT SWELLING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN (OXYGEN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529934-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106626</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529936-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108031</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529938-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108097</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529940-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108184</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529941-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098693</companynumb>
    <primarysource></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>21341</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529942-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103610</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>122.4712</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>(10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529943-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040924</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413113JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS ANTIGEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELDENE</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529944-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104657</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529946-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103864</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>(200 MG, PRN)</drugdosagetext>
        <drugindication>MUSCULOSKELETAL DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIGOUT PREPARATIONS (ANTIGOUT PREPARATIONS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTITHYROID PREPARATIONS (ANTITHYROID PREPARATIONS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529947-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101807</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>   (1 IN 1 D),</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (VITAMINS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529948-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410303JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</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>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFUSE ALVEOLAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CONSOLIDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>DOSE: 3 CAPSULES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>DOSE: 10 MG/WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>DOSE: 3 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS EROSIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KOLANTYL GEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCTIVE COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040219</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529949-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106538</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529950-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.6579</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLONIC CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN 300 MG AM</medicinalproduct>
        <drugdosagetext>300 MG (2) Q AM</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN 300 MG AM</medicinalproduct>
        <drugdosagetext>300 MG (2) Q AM</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529951-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101098</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529952-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>30 MG /M2 D1, 8, 15</drugdosagetext>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>30 MG /M2 D1, 8, 15</drugdosagetext>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>250 MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040524</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529953-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106578</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>      (10 MG)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529954-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION PLEURAL CAVITY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOODY DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>36 MG/M2</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>36 MG/M2</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>36 MG/M2</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>250 MG QD</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040910</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529955-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102138</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE BRUISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529956-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXIL</medicinalproduct>
        <drugdosagetext>36 MG/M2</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXIL</medicinalproduct>
        <drugdosagetext>36 MG/M2</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXIL</medicinalproduct>
        <drugdosagetext>36 MG/M2</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXIL</medicinalproduct>
        <drugdosagetext>36 MG/M2</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>250 MG/M2</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529957-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE`</medicinalproduct>
        <drugdosagetext>INITIAL , 400 MG PO DAILY, THEN 100 MG PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LECTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENOFER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529958-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106475</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTOGENS CONJUGATED (ESTROGENS CONJUGATED)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529959-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugdosagetext>EVERY 3 WEEKS1462 -12 DOSES OVER 4 DAYS EVERY 3 WEEKS</drugdosagetext>
        <drugindication>SARCOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugdosagetext>EVERY 3 WEEKS 156 MG -QD X 4 DAYS</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugdosagetext>4300 MG X4 DAYS EVERY 3 WEEKS</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529960-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004090414</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.4932</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>100 MG (100 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARISOPRODOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB (CELECOXIB)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529961-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPHEDRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529967-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2004-0017686</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529968-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106478</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529969-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106490</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529970-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106567</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROGENS CONJGUATED (ESTROENS CONJUGATED)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529971-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106584</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROGENS CONJGATED (ESTROGENS CONJUGATED)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529972-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413606EU</companynumb>
    <primarysource>
      <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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODE UNBROKEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISON</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPREX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE 25/250</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugdosagetext>DOSE: 4-6; DOSE UNIT: UNITS</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529973-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413662EU</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-SMALL CELL LUNG CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030318</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030318</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STEROID THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030318</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529974-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413863JP</companynumb>
    <primarysource>
      <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>TAXOTERE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529975-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413827JP</companynumb>
    <primarysource>
      <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>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACYT</medicinalproduct>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529977-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105372</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529981-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105375</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529982-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15635</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSPASM CORONARY</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 POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>5 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040331</drugenddate>
        <drugtreatmentduration>369</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040407</drugenddate>
        <drugtreatmentduration>379</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030330</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTCILLIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030330</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>8 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040331</drugenddate>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030331</drugenddate>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>60 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030331</drugenddate>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN</medicinalproduct>
        <drugdosagetext>2 TO 8 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030327</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030326</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529983-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104444</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
        <drugauthorizationnumb>18422</drugauthorizationnumb>
        <drugdosagetext>1200 MG (600 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529985-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-JNJFOC-20041202095</companynumb>
    <primarysource>
      <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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529986-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20041202295</companynumb>
    <primarysource>
      <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>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugindication>MENTAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPOTEN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529988-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041201527</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040816</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529989-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041202428</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0418623</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529990-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041106292</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRAMIL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLAC DISPERS</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529991-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041203926</companynumb>
    <primarysource>
      <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>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529993-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100124</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <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>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED), MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529994-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20041201667</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529995-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20040701114</companynumb>
    <primarysource>
      <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>EXCITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNITRAZEPAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEPRENONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE MALEATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FK</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FK</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FK</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FK</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FK</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FK</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529996-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20040800675</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EBIXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529997-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041101067</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRABENAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRABENAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRAMIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529998-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040809762</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4529999-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041004498</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530000-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041003702</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530001-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041200936</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>15-20 MG/DAILY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530002-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040804627</companynumb>
    <primarysource>
      <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>NEUTROPENIA</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>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugdosagetext>900 MG AM  600 MG PM</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530003-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BR16568</companynumb>
    <primarysource>
      <qualification>5</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>LABYRINTHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
        <drugbatchnumb>U0093</drugbatchnumb>
        <drugdosagetext>1 DF, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ELECTROLYTE SUBSTITUTION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLCADIL</medicinalproduct>
        <drugdosagetext>1 TAB/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HCL W/HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530004-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004IT14871</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEBORRHOEIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DESQUAMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINEA VERSICOLOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLEP</medicinalproduct>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLEP</medicinalproduct>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GARDENALE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GARDENALE</medicinalproduct>
        <drugdosagetext>50 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GARDENALE</medicinalproduct>
        <drugdosagetext>25 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GARDENALE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETANUS GAMMA GLOBULIN</medicinalproduct>
        <drugdosagetext>500 UI/ML/ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530005-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101531</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.2043</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG, (200 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE MITE (FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL (CLOBETASOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530006-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</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>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>17 U Q AM</drugdosagetext>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>10 U Q AM</drugdosagetext>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530007-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102116</companynumb>
    <primarysource></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 TABLET (MEDROXYOGESTERONE ACETATE)</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRING</medicinalproduct>
        <drugdosagetext>2 MG (2 MG), VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530008-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20041106146</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREPULSID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DIABETIC GASTROPARESIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>1.3E/H 0H00-08H00  1.5E/H 08H00-10H00  1 E/H 10H00-14H00  1.7E/H 14H00-22H00  1.6 E/H 22H00-24H00</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROVEL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTHYROX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOPRAID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530009-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106541</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530010-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106550</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530012-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-036287</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE SYSTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA FOR INJECTION (FLUDARABINE PHOSPHATE)</medicinalproduct>
        <drugauthorizationnumb>20038</drugauthorizationnumb>
        <drugdosagetext>25MG/M2 X 3D Q28, INTRAVNEOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB (RITUXIMAB)</medicinalproduct>
        <drugdosagetext>375MG/M2 Q 28D, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENASENSE</medicinalproduct>
        <drugdosagetext>3MG/KG/D X 7D Q28D, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530014-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106594</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530015-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-036191</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040612</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530016-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041201660</companynumb>
    <primarysource>
      <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>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATRECOR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATRECOR</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530018-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106607</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-145 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530020-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-034370</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROGRESSIVE MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE (AMANTADINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN (BABY) (ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX ^BOEHRINGER INGELHEIM^ (TAMSULOSIN HDYROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NOS (VITAMINS NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530022-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108517</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530024-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004CA17036</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERL 080A</medicinalproduct>
        <drugdosagetext>720 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530025-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13288</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOETAL HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHERGINE</medicinalproduct>
        <drugdosagetext>0.05 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530026-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2004-0017976</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530027-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004243276US</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER IN SITU</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATEST H.S.</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530028-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2003-0010587</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>111.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE GRAFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONEHDYROCHLORIDE (SIMILAR TO NDA 20-553) (OXYCODONE HYDROCHLORID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYFAST (OXYCODONE HDYROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELVAIL (AMITRIPTYLINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICOPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMELOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SONATA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530029-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2000087</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY RELATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIMPLE PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>1500 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL-XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530030-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8007998</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>500 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530031-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SU-2004-002867</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENICAR HCT</medicinalproduct>
        <drugauthorizationnumb>21532</drugauthorizationnumb>
        <drugdosagetext>20.125 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530032-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004JP17318</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>350 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000414</drugenddate>
        <drugtreatmentduration>14400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>250 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000518</drugenddate>
        <drugtreatmentduration>48960</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>220 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000612</drugenddate>
        <drugtreatmentduration>36000</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>250 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010328</drugenddate>
        <drugtreatmentduration>289</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>200 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020610</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>2 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000428</drugenddate>
        <drugtreatmentduration>36000</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>1.5 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020610</drugenddate>
        <drugtreatmentduration>773</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>20 MG/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugdosagetext>85MG DR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000404</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530033-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12790341</companynumb>
    <primarysource>
      <qualification>3</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>TAXOL</medicinalproduct>
        <drugdosagetext>THERAPY START 31-AUG-2004</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>THERAPY START 31-AUG-2004</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530034-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-06411-01</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</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>20030714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530035-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEFLOQUINE</medicinalproduct>
        <drugbatchnumb>148304</drugbatchnumb>
        <drugdosagetext>250MG   PER WEEK   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041213</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530036-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040908</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-12696555</companynumb>
    <primarysource>
      <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>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APROVEL TABS 300 MG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040318</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-THYROXINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOITRE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530037-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-07469-01</companynumb>
    <primarysource>
      <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>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</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>20040212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugdosagetext>1.5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugdosagetext>0.75 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530038-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12758850</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COLON CANCER</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>1ST INFUSION 18-MAR-04 (800 MG), REC'D 38 CC/76 MG. D/C 19-MAR-04</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040318</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040318</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040318</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040318</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530039-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040825</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12682761</companynumb>
    <primarysource>
      <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>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBACUTE ENDOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>T-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABATACEPT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031112</drugenddate>
        <drugtreatmentduration>959</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021126</drugenddate>
        <drugtreatmentduration>244</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANAKINRA</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>DOSE VARIED FROM 7 MG TO 10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>DOSAGE FORM = 7.5/500 TABLET; 1 TID PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugdosagetext>1-2 TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011023</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530041-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>136.0791</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>60MG   2X</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>60MG   2X</drugdosagetext>
        <drugindication>POST-TRAUMATIC SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530042-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-07716-01</companynumb>
    <primarysource>
      <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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUILLAIN-BARRE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</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>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530043-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NECON 7/7/7     WATSON</medicinalproduct>
        <drugbatchnumb>4CA559</drugbatchnumb>
        <drugdosagetext>1 PILL A DAY    28 DAYS    ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NECON 7/7/7     WATSON</medicinalproduct>
        <drugbatchnumb>4CA559</drugbatchnumb>
        <drugdosagetext>1 PILL A DAY    28 DAYS    ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENSTRUAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530044-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>T04-USA-07469-01</companynumb>
    <primarysource>
      <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>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</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>20040212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugdosagetext>1.5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugdosagetext>0.75 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530045-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84.369</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>1 PER DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugdosagetext>1 PER DAY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530046-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>M04-341-133</companynumb>
    <primarysource>
      <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>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFRACTORY ANAEMIA WITH AN EXCESS OF BLASTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>AMYLOIDOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530047-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.7913</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>1   DAILY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530048-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRUXISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLUMSINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE STOOLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>200MG   DAY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040318</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>200MG   DAY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040318</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530049-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2004-0015384</companynumb>
    <primarysource>
      <qualification>3</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMARTHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPROTHROMBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE ACCIDENTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STARING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VEIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORCET-HD</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE (DEXTROPROPOXYPHENE)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINE DERIVATIVES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISTARIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARAFON FORTE (CHLORZOXAZONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROBID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINSENG (GINSENG)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (POTASSIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530050-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDESLEUKIN</medicinalproduct>
        <drugdosagetext>54.08 MM/IU IV EVERY 8 HOUS FOR 12 DOSES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDESLEUKIN</medicinalproduct>
        <drugdosagetext>54.08 MM/IU IV EVERY 8 HOUS FOR 12 DOSES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCLOPERAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMONOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MG SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM PHOSPHATES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPERIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530051-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004093237</companynumb>
    <primarysource>
      <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>LYME DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE (ESOMEPRAZOLE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530052-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugbatchnumb>X200652</drugbatchnumb>
        <drugdosagetext>150 MG   QD   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugbatchnumb>X101862</drugbatchnumb>
        <drugdosagetext>100 MG   2TABS QD   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530053-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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 DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
        <drugbatchnumb>4H0403</drugbatchnumb>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530054-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.5755</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLLAPSE OF LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELOFIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugdosagetext>DOSE DAILY</drugdosagetext>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530055-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12016</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTITHROMBIN III DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY SMALL INTESTINE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BOWEL SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECHOCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST-T SEGMENT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ANASTOMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LAPAROTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MESENTERIC VASCULAR INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN S DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>81 MG, QD</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
        <drugtreatmentduration>102</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530056-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR PERIPHERAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugdosagetext>200 MG 2X/DAY</drugdosagetext>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530057-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004091826</companynumb>
    <primarysource></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>ZYRTEC</medicinalproduct>
        <drugauthorizationnumb>19835</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530058-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>42.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>12 MG IT ONCE ON 12/6</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>PRECURSOR T-LYMPHOBLASTIC LYMPHOMA/LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>100MG IV ON 12/6 + 12/7</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRECURSOR T-LYMPHOBLASTIC LYMPHOMA/LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530059-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SU-2004-002871</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERNATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENICAR HCT</medicinalproduct>
        <drugauthorizationnumb>21532</drugauthorizationnumb>
        <drugdosagetext>MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530060-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030610</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0002503</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.0083</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHYOL</medicinalproduct>
        <drugauthorizationnumb>20221</drugauthorizationnumb>
        <drugdosagetext>500 MG, 5 IN 1 WK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RADIOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE (GLIPIDIZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530061-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106526</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530062-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104665</companynumb>
    <primarysource>
      <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>ANTICONVULSANT DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN KAPSEAL</medicinalproduct>
        <drugauthorizationnumb>84349</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D) , ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530063-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004243586US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JOINT INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>50 MG, SINGLE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JOINT INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530064-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106519</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530065-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106437</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ZYGOMYCOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugauthorizationnumb>19949</drugauthorizationnumb>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530066-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102166</companynumb>
    <primarysource>
      <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>BLADDER CANCER RECURRENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugauthorizationnumb>20280</drugauthorizationnumb>
        <drugdosagetext>0.4 MG (DAILY),SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040302</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530067-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105159</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.7913</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM (LITHIUM)</medicinalproduct>
        <drugauthorizationnumb>16834</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>200 MG (100 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530068-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101074</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OGEN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>4530069-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-031994</companynumb>
    <primarysource>
      <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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530070-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103390</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.4932</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB(CELECOXIB)</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>(1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE INJECTION (MORPHINE SULFATE)</medicinalproduct>
        <drugindication>POST PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>(6 IN 1 AS NECESSARY)</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE (TRIAMTERENE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN 9ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS (ASCORBIC ACID, ERGOCALCIFEROL, FOLIC ACID, NICOTINAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PROUCTS (ALL OTHER THERAPETUIC PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530071-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>205517</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530072-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2004-0017958</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.4</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASEPT 4% (CHLORHEXIDINE GLUCONATE) TOPICAL SOLUTION</medicinalproduct>
        <drugauthorizationnumb>19125</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530073-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>205831</companynumb>
    <primarysource>
      <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 IN SITU</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN 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>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERI-COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASTROL OIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530074-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098648</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>250</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX (LEVODOPA) (CELECOXIB)</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX (LEVODOPA) (CELECOXIB)</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (POTASSIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN (VALSARTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAXALONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530075-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105565</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugauthorizationnumb>19885</drugauthorizationnumb>
        <drugdosagetext>40 MG (20 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530076-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16470</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK SECOND DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB TRAUMATIC AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>600 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENYTOIN</medicinalproduct>
        <drugdosagetext>300 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
        <drugdosagetext>15 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugdosagetext>300 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530077-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16532</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXCITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>400 MG/DAY</drugdosagetext>
        <drugindication>TEMPORAL LOBE EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
        <drugdosagetext>10 MG/DAY</drugdosagetext>
        <drugindication>TEMPORAL LOBE EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
        <drugdosagetext>18 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>900 MG/DAY</drugdosagetext>
        <drugindication>TEMPORAL LOBE EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>800 MG/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530078-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF DESPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>DYSTHYMIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020908</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530079-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02100-USA-04-0386</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUNCTURE SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugauthorizationnumb>20863</drugauthorizationnumb>
        <drugdosagetext>100 MG DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERMITTENT CLAUDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530080-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NOSOCOMIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERINEPHRIC ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CAVITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>MONTHLY INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530081-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.3273</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED CRYPTOCOCCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>MONTHLY INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530082-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-07767-01</companynumb>
    <primarysource>
      <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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530083-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16603</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugindication>TEMPORAL LOBE EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>TEMPORAL LOBE EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>800 MG/DAY</drugdosagetext>
        <drugindication>TEMPORAL LOBE EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>1000 MG/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530084-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugdosagetext>200MG  QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530085-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16605</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOROSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>400 MG/DAY</drugdosagetext>
        <drugindication>TEMPORAL LOBE EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
        <drugdosagetext>10 MG/DAY</drugdosagetext>
        <drugindication>TEMPORAL LOBE EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>1000 MG/DAY</drugdosagetext>
        <drugindication>TEMPORAL LOBE EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugindication>TEMPORAL LOBE EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530086-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15854</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBLITERATIVE BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOMEDIASTINUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FK 506</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRRADIATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530087-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>R301146-PAP-USA</companynumb>
    <primarysource>
      <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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530088-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>20MG  BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>20MG  BID ORAL</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT INHALERS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530089-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugdosagetext>10MG  QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMNESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSYLLIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530090-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04120292</companynumb>
    <primarysource>
      <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>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040815</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530091-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200MG  Q  DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTC FIBER SUPPLEMENTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530092-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04120267</companynumb>
    <primarysource>
      <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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>400 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530093-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>041208-0000500</companynumb>
    <primarysource>
      <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>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STUPOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHAMPHETAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>5378</drugauthorizationnumb>
        <drugdosagetext>NAS</drugdosagetext>
        <drugindication>DRUG THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530094-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040819</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12677365</companynumb>
    <primarysource>
      <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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>100 MG DOSE 19-FEB-2004 TO 15-JUL2004; 16TH DOSE 80 MG 12-AUG-2004</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040812</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>WITH DEXTROSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040812</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040812</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040812</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040812</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530095-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-07880BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.02</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugauthorizationnumb>20938</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNVISC (HYALURONATE SODIUM)</medicinalproduct>
        <drugdosagetext>SEE TEXT (2 ML 1X PER WEEK FOR 2 WKS. IN RIGHT KNEE), IR</drugdosagetext>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530096-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16071</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRENOCORTICOTROPHIC HORMONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN</medicinalproduct>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLASMAPHERESIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEISHI-KA-SYAKUYAKU-TO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530097-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP13059</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KETONURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530098-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-BRISTOL-MYERS SQUIBB COMPANY-12784369</companynumb>
    <primarysource>
      <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>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530099-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040729</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12655734</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>134</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>LOADING DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040719</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040719</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
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  <safetyreport>
    <safetyreportid>4530100-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040823</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-12679502</companynumb>
    <primarysource>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030613</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031008</drugstartdate>
      </drug>
    </patient>
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    <safetyreportid>4530101-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12755724</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugdosagetext>DOSAGE: 2-150 MG CAPSULES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRIVA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040712</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530102-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW22648</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>110.6777</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE MB INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK BILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE HEART DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>5 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530103-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16097</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SICK SINUS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>200 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>1 G/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>20 G/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530104-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2004AU01706</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>200 MG MANE, 300 MG NOCTE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>200 MG MANE, 300 MG NOCTE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530105-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16097</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SICK SINUS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>200 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>1 G/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>20 G/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530106-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030902</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12373213</companynumb>
    <primarysource>
      <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>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>ROUTE OF ADMINISTRATION = DR.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010827</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugdosagetext>ROUTE OF ADMINISTRATION=DR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010820</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRAMUSTINE PHOSPHATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010913</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCYRON</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORM = 3 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRONGER NEO-MINOPHAGEN C</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN SODIUM</medicinalproduct>
        <drugdosagetext>ROUTE=DR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUMARIN</medicinalproduct>
        <drugdosagetext>ROUTE=DR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugdosagetext>ROUTE=DR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENOGLOBULIN-I</medicinalproduct>
        <drugdosagetext>ROUTE=DR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTROGIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010822</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530107-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210672</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugdosagetext>375 MG/M2, 1/WEEK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530108-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210780</companynumb>
    <primarysource>
      <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>CYTOMEGALOVIRUS COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugdosagetext>375  MG/M2, 1/WEEK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530109-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0282738-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPROLACTINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MOOD ALTERED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
        <drugtreatmentduration>128</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040810</drugenddate>
        <drugtreatmentduration>128</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1-4 MG DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>AGITATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYTETRACYCLINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040516</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530110-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0281920-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPHILUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABUMETONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</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>OMEPRAZOLE</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>TRAMADOL HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530111-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0282736-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRIP STRENGTH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPILIM TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DAILY DOSE BETWEEN 800 MG TO 1200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPILIM TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPILIM TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530112-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-04P-062-0278947-00</companynumb>
    <primarysource></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>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA (COMMERCIAL)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA (COMMERCIAL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANTUDAL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530113-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040617</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ABBOTT-04P-150-0264574-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANOMALY OF MIDDLE EAR CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY OF INNER EAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL JAW MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR MALFORMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530114-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031211</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-03P-163-0245195-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031118</drugenddate>
        <drugtreatmentduration>155</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELAVIRDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031118</drugenddate>
        <drugtreatmentduration>155</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031118</drugenddate>
        <drugtreatmentduration>155</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530115-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0276866-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BOWEL SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLUMSINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>X-RAY GASTROINTESTINAL TRACT ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPANTHYL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HESPERIDIN METHYL CHALCONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040807</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETAZIDINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZALDIAR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040807</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROGOL</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMACOL</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER ANTIDIARRHOEALS</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANFLUREX</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMEBUTINE MALEATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APOREX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENUTRYL 500</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530116-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0282384-00</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>EMBOLISM VENOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>18132</drugauthorizationnumb>
        <drugdosagetext>CONTINUOUS</drugdosagetext>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530117-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207137</companynumb>
    <primarysource>
      <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>CARDIAC PACEMAKER INSERTION</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>20040409</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530118-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>201174</companynumb>
    <primarysource>
      <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>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P01042</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P01042</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMMETREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530119-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>204453</companynumb>
    <primarysource>
      <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>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</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>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530120-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097639</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>28</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GERM CELL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITUITARY TUMOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN (SOMATROPIN)</medicinalproduct>
        <drugauthorizationnumb>20280</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030708</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN (SOMATROPIN)</medicinalproduct>
        <drugauthorizationnumb>20280</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESMOPRESSION (DESMOPRESSIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530121-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041202133</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPANOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ICAZ</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NISISCO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NISISCO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORVASAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530122-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041200419</companynumb>
    <primarysource>
      <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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
        <drugtreatmentduration>200</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>AS REQUIRED, ACCORDING TO BLOOD SUGAR</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530123-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041106083</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>1.68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPITOMAX</medicinalproduct>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040302</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530124-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0281558-00</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugauthorizationnumb>18132</drugauthorizationnumb>
        <drugdosagetext>CONTINOUS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530125-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-JNJFOC-20041202114</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugdosagetext>UP TO 40MG</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530126-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041202474</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEMPHIGOID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERMION</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RENITEC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIVASTAL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFAN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRESTOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRESTOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530127-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041202477</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530128-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041002567</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.11</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAT STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugdosagetext>(5MG TAKEN AT NIGHT)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530129-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041106817</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL DECANOATE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL DECANOATE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN LACTATE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE HCL</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNITRAZEPAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROTIZOLAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAZOLAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530130-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-JNJFOC-20041202104</companynumb>
    <primarysource>
      <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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY BLADDER RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOMIPRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUPHANZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530131-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20040303131</companynumb>
    <primarysource>
      <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>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530132-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041201292</companynumb>
    <primarysource>
      <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>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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530133-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106471</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530134-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041002827</companynumb>
    <primarysource>
      <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040912</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE VALERATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ECZEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ECZEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530135-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
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    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041100348</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULOMUCOCUTANEOUS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEPRENONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOCONAZOLE</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>TINEA PEDIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530136-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
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    <receiptdate>20041206</receiptdate>
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    <companynumb>JP-JNJFOC-20041201285</companynumb>
    <primarysource>
      <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>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041017</drugstartdate>
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        <drugenddate>20041121</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
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        <drugenddate>20041121</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERBINAFINE HCL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
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        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530137-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041004277</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530138-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0282342-00</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>18132</drugauthorizationnumb>
        <drugdosagetext>CONTINUOUS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530139-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106482</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530140-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106484</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530141-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106452</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.8957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>EVERY 3 MONTHS, 1ST INJ</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMCICLOVIR (FAMCICLOVIR)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530142-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041202600</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPIPHYSES PREMATURE FUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530143-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004090355</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugauthorizationnumb>6146</drugauthorizationnumb>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL ALLERGY/SINUS  (DIPHENHYDRAMINE, PSEUDOEPHEDRINE)</medicinalproduct>
        <drugdosagetext>4 IN 1 D</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE (TRAZODONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530144-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9372</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOMYCIN</medicinalproduct>
        <drugdosagetext>6 MG/M2 DAILY; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LEIOMYOSARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>40 MG/M2 DAILY; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LEIOMYOSARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>60 MG/M2 DAILY; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LEIOMYOSARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACARBAZINE</medicinalproduct>
        <drugdosagetext>750 MG/M2 DAILY; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LEIOMYOSARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GM-CSF</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530145-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105413</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.7913</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOSTINEX</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PITUITARY TUMOUR BENIGN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM (LEVOTHYROXINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530146-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004IM000568</companynumb>
    <primarysource>
      <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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIMMUNE</medicinalproduct>
        <drugdosagetext>BIW; SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INTERSTITIAL LUNG DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020822</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530147-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>203474</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.4212</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URISPAS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROPATCH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMADEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530148-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004IM000981</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIMMUNE</medicinalproduct>
        <drugdosagetext>50 UG; TIW</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFERGEN</medicinalproduct>
        <drugdosagetext>17 UG; QD</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>1000 MG; QD</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530149-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE856608DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.8</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION FUNGAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYLOTARG</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>200 MG/M^2 1X PER 1 DAY; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA (MAGNESIUM HYDROXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530150-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>400MG  BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530151-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.5734</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugdosagetext>800MG  AT BEDTIME ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041212</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530152-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004IM000875</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIMMUNE</medicinalproduct>
        <drugbatchnumb>303143</drugbatchnumb>
        <drugdosagetext>70 UG; TIW; SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NEUTROPHIL FUNCTION DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021002</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530153-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10MG  QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040911</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530154-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004IM000641</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.0291</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANASTOMOTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ANASTOMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON GAMMA-1B</medicinalproduct>
        <drugdosagetext>100 UG; TIW; SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>450 MG; Q3W; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>319; MG; Q3W; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLESTID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530155-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.1324</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCOAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>20MG/MG  DAILY X 5 INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>15 MG/M2  DAILY X 5 INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530156-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFAZOLIN</medicinalproduct>
        <drugdosagetext>1 GRAM ONCE DAILY INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530157-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9406</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>11719</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530158-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>24.0406</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>25MG  TID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSOLINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530159-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE871009DEC04</companynumb>
    <primarysource></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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530160-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84.369</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE  600MG  WYETH</medicinalproduct>
        <drugdosagetext>ONE TWICE DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040620</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530161-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.3899</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>20 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>20 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugdosagetext>40MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugdosagetext>40MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530162-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE256003DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEREOTYPIC MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEARFULNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>75MG DAYS 1-3; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530163-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>205671</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530164-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>205946</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</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>20020130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530165-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9396</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>11719</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530166-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-AMGEN-UK101998</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINERET</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530167-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9321</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEMOTHERAPEUTIC DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>11719</drugauthorizationnumb>
        <drugdosagetext>5.4 MG QD; IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugdosagetext>250 MG QD;</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530168-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>206732</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.7913</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UQ; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530169-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000103</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</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>19970101</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>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530170-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>204313</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED CELL DISTRIBUTION WIDTH INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOTAL CHOLESTEROL/HDL RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT 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>20040326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIQUID TEARS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITLOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYL SALICYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530171-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>201626</companynumb>
    <primarysource>
      <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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER STAGE I</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530172-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>202617</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</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>20021101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROXL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530173-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000555</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</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>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530174-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE778207DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA NODOSUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INIPOMP (PANTOPRAZOLE, TABLET, DELAYED RELEASE)</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
        <drugdosagetext>40 MG 1X PER 1 DAY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INIPOMP (PANTOPRAZOLE, TABLET, DELAYED RELEASE)</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
        <drugdosagetext>40 MG 1X PER 1 DAY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROENTERITIS NONINFECTIOUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHILOROGLUCINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SMECTITE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SACCHARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530175-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117.9352</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEPTRA DS</medicinalproduct>
        <drugdosagetext>800/160MG  TWICE DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HAEMOPHILUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-ENZYME Q</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530176-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE778507DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMAC (PANTOPRAZOLE, UNSPEC)</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530177-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIINFLAMMATORY THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530178-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>CARDIOACTIVE DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>0.25MG  DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530179-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041209</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530180-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>ONE TABLT  1X 7DAYS ORAL ;  1/2 TABLT  1X/12 DAYS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>ONE TABLT  1X 7DAYS ORAL ;  1/2 TABLT  1X/12 DAYS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST PROCEDURAL COMPLICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE DIURETIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530181-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.3586</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC DIABETES INSIPIDUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM  450MG ER</medicinalproduct>
        <drugdosagetext>450MG ER BID-1,2- ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM MVI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KCL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMHRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530182-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN  2MG  DUPONT</medicinalproduct>
        <drugdosagetext>1MG/2MG  MWF + ROW  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERIPHERAL VASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM A-D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530183-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA VIRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRAMUSTINE</medicinalproduct>
        <drugdosagetext>140MG  BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>76 MG  WEEKLY INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530184-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000547</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>151.0478</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIGAMENT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEELCHAIR USER</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>20040902</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530185-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000560</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMEVIVE</medicinalproduct>
        <drugdosagetext>15 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMEVIVE</medicinalproduct>
        <drugdosagetext>15 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530186-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000550</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.8748</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTMENOPAUSAL HAEMORRHAGE</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>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>20030501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530187-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000575</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530188-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000552</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.318</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</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>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020701</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>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530189-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000578</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS</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>20010310</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>4530190-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>203411</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</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>20031101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530191-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE317809NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE (AMIODARONE, INJECTION)</medicinalproduct>
        <drugauthorizationnumb>20377</drugauthorizationnumb>
        <drugdosagetext>300 MG 1X PER 1 DAY; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041024</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530192-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE750003DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>20377</drugauthorizationnumb>
        <drugdosagetext>150 MG, FREQUENCY UNKNOWN; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>1 DF DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugdosagetext>25 MG, FREQUENCY UNKNOWN; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>0.15 MG, FREQENCY UNKNOWN; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugdosagetext>UNSPECIFIED; ORAL</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>UNSPECIFIED; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOZITEC (FOSINOPRIL, )</medicinalproduct>
        <drugdosagetext>20 MG, FREQUENCY UNKNOWN; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HAVLANE (LOPRAZOLAM MESILATE, )</medicinalproduct>
        <drugdosagetext>1 MG, FREQUENCY UNKNOWN; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>UNSPECIFIED; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL/TRAMADOL HYDROCHLORIDE (PARACETAMOL/TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>25 MG, FREQUENCY UNKNOWN; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SER ^SOLVAY^ (BETAHISTINE HYDROCHLORIDE, )</medicinalproduct>
        <drugdosagetext>8 MG, FREQUENCY UNKNOWN; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
        <drugdosagetext>4 MG, FREQUENCY UNKOWN; ORAL</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>UNSPECIFIED; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530193-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE780607DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NATRIURETIC PEPTIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OSTELUC (ETODOLAC, UNSPEC)</medicinalproduct>
        <drugauthorizationnumb>18922</drugauthorizationnumb>
        <drugdosagetext>400 MG 1X PER 1 DAY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPONDYLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040908</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ECABET MONOSODIUM (ECABET MONOSODIUM, )</medicinalproduct>
        <drugdosagetext>2 G 1X PER 1 DAY;</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040908</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530194-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004094849</companynumb>
    <primarysource>
      <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>ANION GAP INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTICTAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISTARIL</medicinalproduct>
        <drugauthorizationnumb>11111</drugauthorizationnumb>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOROLAC TROMETHAMINE</medicinalproduct>
        <drugdosagetext>INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM CITRATE (MAGNESIUM CITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOLYTELY (MACROGOL, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISICOL (SODIUM PHOSPHATE DIBASIC, SODIUM PHOSPHATE MONOBASIC (MONOHYD</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530195-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421955GDDC</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 1 PUFF</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>NASAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSMOFER</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530196-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414629FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>XANTHOPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CERVICAL GLAND TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYAMBUTOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMIFON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRILENE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530197-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414632FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COR PULMONALE CHRONIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530198-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200422017GDDC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAMORPH SR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBANDRONIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCHLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530199-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041212</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200422120GDDC</companynumb>
    <primarysource>
      <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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugbatchnumb>D177 SEP-04</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CAESAREAN SECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOREN</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>POSTOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VELOSEF INJECTION</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041212</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530200-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419499US</companynumb>
    <primarysource>
      <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 MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530201-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RB-1142-2004</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNSPECIFIED THERAPEUTIC AGENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530202-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200412422DE</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL CARDIOVASCULAR ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL MACROSOMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYHYDRAMNIOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530203-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040910</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413412FR</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>110</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SODIUM RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAPID ACTING INSULIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDYFERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORECORMON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530204-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040319</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410610DE</companynumb>
    <primarysource>
      <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>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIASTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530205-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410648FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>145</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NATRIURETIC PEPTIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRETERAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELESTENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PNEUMOREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIMETAPP</medicinalproduct>
        <drugindication>BRONCHITIS ACUTE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
        <drugindication>BRONCHITIS ACUTE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530206-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEFITINIB 250MG TABS, ASTRAZENECA</medicinalproduct>
        <drugdosagetext>500 MG PO, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugdosagetext>10 MG PO, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL PRN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530207-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RB-958-2004</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530208-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASODILATATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JOHNSON + JOHNSON CYPHER MEDICATED SIROLIMUS STENTS</medicinalproduct>
        <drugbatchnumb>Y1103940/41103014/Y1</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530209-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB MESYLATE 100MG CAPSULES, NOVARTIS</medicinalproduct>
        <drugdosagetext>600MG, PO QD X 8 PER 28 DAY CYCLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE, SCHERING-PLOUGH</medicinalproduct>
        <drugdosagetext>350MG, PO QD X 5 PER 28 DAY CYCLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530210-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004DK16591</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>1000 MG EVERY 2 WEEKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530211-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US102450</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>112.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041209</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITRON-C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530212-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED SELF-CARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEFITINIB 250MG TABS, ASTRA-ZENECA</medicinalproduct>
        <drugdosagetext>500 MG PO, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugdosagetext>10 MG PO, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGIC MOUTH WASH WITH LIDOCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE/NYSTATIN OINTMENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530213-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-UK-01284UK</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugdosagetext>18 MCG (18 MCG,) IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE (NR)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530214-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530215-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.4514</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEREAVEMENT REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN SOCIAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF DESPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANDIOSITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF EMPLOYMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RELATIONSHIP BREAKDOWN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYLERT</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMIPRAM TAB</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530216-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAPTOMYCIN   500MG   CUBIST</medicinalproduct>
        <drugbatchnumb>180503A</drugbatchnumb>
        <drugdosagetext>320MG   QD   INTRAVENOU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ARTHRITIS INFECTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAPTOMYCIN   500MG   CUBIST</medicinalproduct>
        <drugbatchnumb>180503A</drugbatchnumb>
        <drugdosagetext>320MG   QD   INTRAVENOU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MEDICAL DEVICE COMPLICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530217-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR TEXTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DRYNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19941130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530218-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108052</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SHOULDER OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>1200 MG (300 MG, 4 IN 1 D)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530219-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104706</companynumb>
    <primarysource>
      <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>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>900 MG (300 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE (FLOXETINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLTERODINE TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530220-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-NOVOPROD-240711</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>300 UG/KG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UPPER GASTROINTESTINAL HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>1200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDOSTATIN</medicinalproduct>
        <drugdosagetext>50 UNK, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDOSTATIN</medicinalproduct>
        <drugdosagetext>1.2 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OFLOCET</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>3 G, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530221-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004087626</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTRAST MEDIA REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL TEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID FACTOR POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM (RISEDRONATE SODIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530222-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105611</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RELPAX</medicinalproduct>
        <drugauthorizationnumb>21016</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530223-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104660</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.5338</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL CHANGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>8762</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugdosagetext>25 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-ASTHMATICS (ANTI-ASTHMATICS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES (ANTIHYPERTENSIVES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530224-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004068315</companynumb>
    <primarysource>
      <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>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>1600 MG (800 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530225-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>206963</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OS-CAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIVELLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOCADREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530226-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104104</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.4306</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACROCHORDON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT RANGE OF MOTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROSEOLA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT LOSS DIET</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>(EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM 9CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL (FISH OIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530227-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103538</companynumb>
    <primarysource>
      <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>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530228-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-DE-05956GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEVIRAPINE (NEVIRAPINE) (NR) (NEVIRAPINE)</medicinalproduct>
        <drugauthorizationnumb>20636</drugauthorizationnumb>
        <drugdosagetext>INITIAL DOSE OF 200 MG/D FOR 14 DAYS, FOLLOWED BY 200 MG TWICE DAILY (NR) PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPIATE (OPIAT) (NR)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530229-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8007264</companynumb>
    <primarysource>
      <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>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COSTOVERTEBRAL ANGLE TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL CONDITION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>500 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMID</medicinalproduct>
        <drugdosagetext>320 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRAIN NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530230-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>25697</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugauthorizationnumb>20208</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS (INSULIN GLARCINE)</medicinalproduct>
        <drugdosagetext>INJECTION</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN (LOSARTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMOL (PARACETAMOL, DEXTROPROPOXYPHENE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530231-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8007068</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUGULAR VEIN DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESUSCITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>750 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>1 G /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530232-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2004A00915</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE FEBRILE NEUTROPHILIC DERMATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>20406</drugauthorizationnumb>
        <drugdosagetext>15 MG (15 MG, 1 IN 1 D) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>20406</drugauthorizationnumb>
        <drugdosagetext>15 MG (15 MG, 1 IN 1 D) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE (CETIRIZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXOCOBALAMIN (HYDROXOCOBALAMIN) (INJECTION)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530233-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>109</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>7.5MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE CR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERBINAFINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530234-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>7.5 MG PO Q WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL INH SOLN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERMETHRIN CR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530235-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530236-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DROOLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530237-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8008229</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS ANTIBODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RUBELLA ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICELLA ZOSTER VIRUS SEROLOGY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL RASH</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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>1500 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530238-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DROOLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530239-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102345</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530240-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530241-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00632</companynumb>
    <primarysource>
      <qualification>1</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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST WALL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001017</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530242-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530243-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103148</companynumb>
    <primarysource></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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLIOGEST ^NOVO INDUSTRI^ (ESTRADIOL, NORETHISTERONE ACETATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530244-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530245-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104361</companynumb>
    <primarysource>
      <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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530246-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APRI 28-DAY ORAL CONTRACEPTIVE TABLETS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530247-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103037</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIAPHRAGMATIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-ABDOMINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>50467</drugauthorizationnumb>
        <drugdosagetext>55 MG (QD), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SYNOVIAL SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugdosagetext>3.7 GRAM (QD), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SYNOVIAL SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACARBOSE (ACARBOSE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMETIDINE HYDROCHLORIDE (CIMETIDINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAZOLAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE IN PLASTIC CONTAINER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530248-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HECTOROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530249-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108066</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FLUTTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugauthorizationnumb>11856</drugauthorizationnumb>
        <drugdosagetext>1 GRAM, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BEHCET'S SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN (WARFARIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN-FRACTION, SODIUM SALT (HEPARIN-FRACTION, SODIUM SALT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530250-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000461</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101.6057</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMEVIVE</medicinalproduct>
        <drugdosagetext>15 MG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530251-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004097851</companynumb>
    <primarysource>
      <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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20882</drugauthorizationnumb>
        <drugdosagetext>300 MG (100 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE (PANTOPRAZOLE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530252-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105777</companynumb>
    <primarysource></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>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugdosagetext>40 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530253-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103842</companynumb>
    <primarysource>
      <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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugauthorizationnumb>19949</drugauthorizationnumb>
        <drugdosagetext>400 MG (1 D)</drugdosagetext>
        <drugindication>ENCEPHALOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugauthorizationnumb>19949</drugauthorizationnumb>
        <drugdosagetext>400 MG (1 D)</drugdosagetext>
        <drugindication>HISTOPLASMOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugindication>ENCEPHALOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugindication>HISTOPLASMOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRAZINAMIDE</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>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530254-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103779</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
        <drugauthorizationnumb>20931</drugauthorizationnumb>
        <drugdosagetext>500 MCG (250 MCG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530255-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105764</companynumb>
    <primarysource>
      <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>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIBODY TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>5 MG (2.5 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN (VALSARTAN)</medicinalproduct>
        <drugdosagetext>160 MG (80 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530256-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004092921</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>50670</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530257-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104688</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>ARRHYTHMIA SUPRAVENTRICULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
        <drugauthorizationnumb>20931</drugauthorizationnumb>
        <drugdosagetext>250 MCG (125 MCG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN (WARFARIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHIMAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON (IRON)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN GLARGINE (INSULIN GLARGINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS (ASCORBIC ACID/ERGOCALCIFEROL/FOLIC ACID/NICOTINAMIDE/PA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530258-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13032</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>5 MG AMLOD/20 MG BENAZ QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRO-K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530259-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01200</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN (AZATHIOPRINE)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530260-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004088987</companynumb>
    <primarysource>
      <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>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCORMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS FUNGAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>21267</drugauthorizationnumb>
        <drugdosagetext>800 MG (400 MG, 1 IN 12HR), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ORAL CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOSYN (PIPERACILLIN SODIUM, TAZOBACTAM DOSIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN (CLINDAMYCIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPENEM (IMIPENEM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B, LIPOSOME (AMPHOTERICIN B, LIPOSOME)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530261-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20010529</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-01062655</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT RANGE OF MOTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010911</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530262-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00713</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001030</drugenddate>
        <drugtreatmentduration>253</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET TABLETS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530263-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0412USA01266</companynumb>
    <primarysource>
      <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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530264-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030609</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA01227</companynumb>
    <primarysource>
      <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>ACTINIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TINEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIDERMAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA ANNULARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL BED BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS ANI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530265-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103557</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530266-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004089442</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.1324</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEEDING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR BYPASS GRAFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>800 MG (400 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10 MG (10 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugdosagetext>10 MG (10 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530267-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040603</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0406USA00247</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020609</drugenddate>
        <drugtreatmentduration>147</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020609</drugenddate>
        <drugtreatmentduration>147</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMFENEX (BROMPHENIRAMINE MALEATE (+) PSEUDOEPHEDRINE HYDROCHLORIDE)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECONSAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530268-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00575</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>145</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530269-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2004A04522</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</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>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>21428</drugauthorizationnumb>
        <drugdosagetext>15 MG (15 MG, 1 D) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXONIN (LOXOPROFEN SODIUM) (PREPARATION FOR ORAL USE (NOS))</medicinalproduct>
        <drugdosagetext>PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DASEN (SERRAPEPTASE) (PREPARATION FOR ORAL USE (NOS))</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE (PREPARATION FOR ORAL USE (NOS))</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL (TABLETS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBAMIPIDE (PREPARATION FOR ORAL USE (NOS))</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM (TABLETS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFCAPENE PIVOXIL HYDROCHLORIDE (PREPARATION FOR ORAL USE (NOS))</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530270-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA04110</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530271-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00699</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLLAGEN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SJOGREN'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETILEFRINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530272-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104710</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530273-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0311USA02538</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL DRYNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010707</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELAFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530274-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.3795</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>10-30MB   DAILY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041213</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530275-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0207USA00488</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TESTOSTERONE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC FATIGUE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPOROMANDIBULAR JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRI-IODOTHYRONINE FREE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACK INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACK INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPERICIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530276-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103665</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20882</drugauthorizationnumb>
        <drugindication>NEUROPATHIC PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530277-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03614</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOWER LIMB FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530278-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugdosagetext>150MG   2X DAILY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugdosagetext>150MG   2X DAILY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugdosagetext>150MG   2X DAILY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STRESS SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040308</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530279-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00928</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530280-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00948</companynumb>
    <primarysource>
      <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>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
        <drugtreatmentduration>1213</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INTERMITTENT CLAUDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530281-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00909</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530282-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103932</companynumb>
    <primarysource>
      <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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORTIS (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOLSIDOMINE (MOLSIDOMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XIPAMIDE (XIPAMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530283-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.4827</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>50MG   DAILY    ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530284-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030805</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0308GBR00030</companynumb>
    <primarysource>
      <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>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEBEVERINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530285-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0412GBR00102</companynumb>
    <primarysource>
      <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>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530286-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00530</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020127</drugenddate>
        <drugtreatmentduration>383</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530287-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00442</companynumb>
    <primarysource>
      <qualification>1</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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>731</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530288-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2004A04033</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIA STOOL IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOTOXIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERINFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSAP 400 (LANSOPRAZOLE, CLARITHROMYCIN, AMOXICILLIN) (PREPARATION FO</medicinalproduct>
        <drugauthorizationnumb>50757</drugauthorizationnumb>
        <drugdosagetext>1 CARD (0.5 CARD, 2 IN 1 D) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS TABLETS 8 (CANDESARTAN CILEXETIL) (TABLETS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HICEE GRANULES (ASCORBIC ACID) (GRANULATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADONA (AC-17) (CARBAZOCHROME SODIUM SULFONATE) (TABLETS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSAMIN (TRANEXAMIC ACID) (CAPSULES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APLACE (TROXIPIDE) (FINE GRANULES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA K (ASPARTATE POTASSIUM) (TABLETS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANIRAPID (METILDIGOXIN) (TABLETS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL (BENIDIPINE HYDROCHLORIDE) (TABLETS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530289-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00808</companynumb>
    <primarysource>
      <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530290-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.9874</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTIONS INVOLUNTARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugbatchnumb>13A767</drugbatchnumb>
        <drugdosagetext>1 TABLET   PER DAY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030221</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530291-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01217</companynumb>
    <primarysource>
      <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>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530292-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-386289</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA-2A</medicinalproduct>
        <drugdosagetext>6 MILLIONU/M2 ONCE A WEEK ON WEEK ONE+ FOUR AND THRICE WEEKLY ON WEEK 2 + 3.  CUMULATIVE DO+</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA-2A</medicinalproduct>
        <drugdosagetext>6 MILLIONU/M2 ONCE A WEEK ON WEEK ONE+ FOUR AND THRICE WEEKLY ON WEEK 2 + 3.  CUMULATIVE DO+</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugdosagetext>10 MILLIONU/M2 ON DAY THREE FOR THREE DAYS ON WEEK 1 + 4 AND 5MILLIONU/M2 THRICE WEEKLY ON WEEK+</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLEUKIN</medicinalproduct>
        <drugdosagetext>10 MILLIONU/M2 ON DAY THREE FOR THREE DAYS ON WEEK 1 + 4 AND 5MILLIONU/M2 THRICE WEEKLY ON WEEK+</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530293-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01230</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530294-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00936</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530295-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01229</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530296-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE MB INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugdosagetext>600MG   BID   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530297-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-MERCK-0412POL00003</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530298-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-353904</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSMISSION OF DRUG VIA SEMEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE CONTRACTIONS DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTANE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTANE</medicinalproduct>
        <drugdosagetext>MONDAY AND FRIDAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530299-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040702</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-373500</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</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>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPTO BISMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTC MEDICATIONS</medicinalproduct>
        <drugdosagetext>MULTIVITAMINS WITHOUT IRON, BIOTIN, VITAMIN E, FISH OIL CAPSULES AND CALCIUM CARBONATE DAILY.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530300-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.9978</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN    2.5MG     BRISTOL-MYERS SQUIBB</medicinalproduct>
        <drugdosagetext>2.5MG   DAILY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530301-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102.9665</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
        <drugdosagetext>12.5/300MG   DAILY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
        <drugdosagetext>12.5/300MG   DAILY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530302-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-383714</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
        <drugtreatmentduration>275</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530303-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03573</companynumb>
    <primarysource>
      <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>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIANOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001020</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530304-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20000721</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-241581</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000513</drugenddate>
        <drugtreatmentduration>159</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>PRN ONLY.  DRUG STATED AS OTC TYLENOL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530305-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.9874</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULINDAC</medicinalproduct>
        <drugdosagetext>200MG   BID   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530306-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-315802</companynumb>
    <primarysource>
      <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>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugdosagetext>FREQUENCY REPORTED AS 1.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
        <drugtreatmentduration>637</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC 325</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530307-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040702</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ROCHE-372866</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIA URINE IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOPERITONEUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>TWO WEEKS TREATMENT FOLLOWED BY ONE WEEK REST</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040503</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXABEPILONE</medicinalproduct>
        <drugdosagetext>ON DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040503</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEGURIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANKIMAZIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530308-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040901</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-379235</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APRANAX</medicinalproduct>
        <drugdosagetext>TAKEN PERIODICALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>TAKEN PERIODICALLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKINE CHRONO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URBANYL</medicinalproduct>
        <drugdosagetext>10 MG DOSAGE STRENGTH UP TO 13 JULY, 5 MG ON 14 JULY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040714</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530309-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040804</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-376803</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLAT FEET</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOLLICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOCHONDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLEX SYMPATHETIC DYSTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENOSYNOVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LICHEN SCLEROSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980616</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990216</drugenddate>
        <drugtreatmentduration>246</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WESTCORT OINTMENT</medicinalproduct>
        <drugdosagetext>DOSAGE REGIMEN REPORTED AS UP TO BID.</drugdosagetext>
        <drugindication>LICHEN SCLEROSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLOCAINE CREAM</medicinalproduct>
        <drugindication>LICHEN SCLEROSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTROBAN</medicinalproduct>
        <drugindication>LICHEN SCLEROSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMOVATE</medicinalproduct>
        <drugindication>LICHEN SCLEROSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530310-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004004204</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS NECROTISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>20 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugdosagetext>160 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19640101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB (CELECOXIB)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE (ESOMEPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE (DOMPERIDONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530311-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-388567</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040904</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HAVLANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040904</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPT-A-MYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THERALENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530312-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9393</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugauthorizationnumb>76108</drugauthorizationnumb>
        <drugindication>ARRHYTHMIA SUPRAVENTRICULAR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530313-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040924</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ROCHE-381433</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>ON DAYS ONE THROUGH FOURTEEN OF A TWENTY-ONE DAY CYCLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040906</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS 243MG DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARINE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARINE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARINE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530314-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-388714</companynumb>
    <primarysource>
      <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>FLUMAZENIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>REVERSAL OF SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugindication>SEDATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEPETAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugdosagetext>DRUG NAME REPORTED AS ^GLYMACKEN/CONCENTRATED GLYCERIN/FRUCTOSE^.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER (JAPAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLITA-T3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530315-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.3993</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>INTERVERTEBRAL DISC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530316-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-386972</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS INFECTIOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530317-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-388788</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530318-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-388639</companynumb>
    <primarysource>
      <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>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugdosagetext>RECEIVED THREE DOSES.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530319-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ROCHE-388844</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugdosagetext>FOR 4 DOSES.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugdosagetext>24 HOURS PRE-TRANSPLANT.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINA</medicinalproduct>
        <drugdosagetext>22-24 NOV 2004: 150 MG BID.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530320-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-388584</companynumb>
    <primarysource>
      <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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED TICLOPIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED TICLOPIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRADYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYFUL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
        <drugdosagetext>INTERRUPTED ON 19 NOV 2004.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugdosagetext>THE 3000 IU WAS ADMINISTERED TWICE, ON DAY 1 AND DAY 3, WHILE THE 5000 IU WAS ADMINISTERED ONCE ON +</drugdosagetext>
        <drugadministrationroute>022</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROL</medicinalproduct>
        <drugadministrationroute>022</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOCAIN</medicinalproduct>
        <drugdosagetext>ON BOTH DAYS.</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugdosagetext>180 ML ON 13/11/04 AND 65 ML ON 20/11/04.</drugdosagetext>
        <drugadministrationroute>022</drugadministrationroute>
        <drugindication>ARTERIOGRAM CORONARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>FIRST DOSE STOPPED ON 15/11/04 AND THE SECOND DOSE WAS TAKEN JUST ON 20/11/04.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERCINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugdosagetext>LIDOQUICK.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVO-HEPARIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAC-B</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugdosagetext>INTERRUPTED ON 20/11/04.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELTECT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530321-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-389064</companynumb>
    <primarysource>
      <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>ARTERIOSPASM CORONARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530322-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-388871</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>37.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CALCULUS URETERIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETERIC DILATATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030109</drugenddate>
        <drugtreatmentduration>55</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASILIXIMAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIZORIBINE</medicinalproduct>
        <drugdosagetext>MYCOPHENOLATE MOFETIL SWITCHED TO MIZORIBINE.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530323-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA04063</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSMEGEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHABDOMYOSARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030823</drugenddate>
        <drugtreatmentduration>320</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHABDOMYOSARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030819</drugenddate>
        <drugtreatmentduration>316</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHABDOMYOSARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030819</drugenddate>
        <drugtreatmentduration>316</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530324-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106577</companynumb>
    <primarysource></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>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530325-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-ROCHE-389322</companynumb>
    <primarysource>
      <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>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530326-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9375</companynumb>
    <primarysource></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>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>89519</drugauthorizationnumb>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EKB-569</medicinalproduct>
        <drugdosagetext>25 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030621</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530327-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-389203</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040905</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530328-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01541</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530329-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01039</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530330-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12781233</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530331-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-BRISTOL-MYERS SQUIBB COMPANY-12792420</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COAPROVEL TABS 300MG/12.5MG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530332-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PH-BRISTOL-MYERS SQUIBB COMPANY-12796801</companynumb>
    <primarysource>
      <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>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IXABEPILONE</medicinalproduct>
        <drugdosagetext>THERAPY INITIATED ON 27-JUL-04. PT REC'D 6 CYCLES SO FAR.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>THERAPY INITIATED ON 27-JUL-04. PT REC'D 6 CYCLES SO FAR.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530333-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-NOVOPROD-240045</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD FIBRINOGEN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugdosagetext>600 UG/KG, 5 DOSES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UPPER GASTROINTESTINAL HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
        <drugtreatmentduration>1200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVLOCARDYL</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OFLOCET</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACUPAN</medicinalproduct>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAFORAN</medicinalproduct>
        <drugdosagetext>3 G, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HISTOACRYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530334-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104921</companynumb>
    <primarysource>
      <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>EXANTHEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>50784</drugauthorizationnumb>
        <drugdosagetext>500 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFCAPENE PIVOXIL HYDROCHLORIDE (CEFCAPENE PIVOXIL HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIARAMIDE HYDROCHLORIDE (TIARAMIDE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZELASTINE (AZELASTINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530335-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004008271</companynumb>
    <primarysource>
      <qualification>1</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>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEGALIN-P (AMPICILLIN, SULBACTAM)</medicinalproduct>
        <drugauthorizationnumb>50608</drugauthorizationnumb>
        <drugdosagetext>1.5 MG (3 IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROPROPOXYPHENE HYDROCHLORIDE (DEXTROPROPOXYPHENE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530336-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01138</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEROID WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CRANIOTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040221</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530337-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004088104</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugauthorizationnumb>19835</drugauthorizationnumb>
        <drugdosagetext>10 MG (1D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIZATIDINE</medicinalproduct>
        <drugdosagetext>300 MG (1D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URTICARIA CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLOPATDINE (OLOPATADINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXATOMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEROXACIN (FLEROXACIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530338-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104699</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530339-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-240932</companynumb>
    <primarysource>
      <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 GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugbatchnumb>PW51591</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugbatchnumb>PW51592</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugbatchnumb>PW52111</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530340-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104608</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530341-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102977</companynumb>
    <primarysource>
      <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>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>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030421</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530342-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105290</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530343-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004089818</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>3.44</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL MEGAURETER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOLVULUS OF BOWEL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>50784</drugauthorizationnumb>
        <drugdosagetext>(1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGOLARYNGEAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN -FRACTION, SODIUM SALT (HEPARIN-FRACTION, SODIUM SLAT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSINE (LYSINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530344-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105291</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530345-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004085265</companynumb>
    <primarysource>
      <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>EXANTHEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>50670</drugauthorizationnumb>
        <drugdosagetext>500 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530346-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000437</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMEVIVE (ALEFACEPT)</medicinalproduct>
        <drugdosagetext>7.5 MG;QW;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THROMBO ASS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530347-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugdosagetext>ONE TABLET, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugdosagetext>ONE TAB, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugdosagetext>ONE TAB, HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
        <drugdosagetext>0.1 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530348-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105845</companynumb>
    <primarysource>
      <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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSIONAL DISORDER, PERSECUTORY TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUSTRAL (SERTRALINE)</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>(2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE (QUETIAPINE)</medicinalproduct>
        <drugdosagetext>25 MG (25 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>HALLUCINATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE (LACTULOSE0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-AMILOFRUSE(AMILORIDE HYDROCHLORIDE, FUROSEMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL (CODEINE PHOSPHATE, PARACETAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA (SENNA)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530349-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004040669</companynumb>
    <primarysource>
      <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>COLLAGEN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE SUBCUTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>AS NECESSARY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN (VALSARTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530350-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105289</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530351-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004073722</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CANDIDA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>21266</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>21266</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINEZOLID (LINEZOLID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530352-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.7716</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE 25MG ONE OD IN AM</medicinalproduct>
        <drugdosagetext>25 MG PO OD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE 25MG ONE OD IN AM</medicinalproduct>
        <drugdosagetext>25 MG PO OD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530353-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101967</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXANTHEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE IV HYPERSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE (LEVOMEPROMAZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530354-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.8211</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL   100MG/M2</medicinalproduct>
        <drugdosagetext>169 MG, Q21DAYS, IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CERVIX CARCINOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041206</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530355-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.8435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED GASTRIC EMPTYING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>70 MG Q WEEK</drugdosagetext>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>35 MG Q WEEK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530356-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2004GB00475</companynumb>
    <primarysource></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>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL (NGX) (ATENOLOL)</medicinalproduct>
        <drugauthorizationnumb>73025</drugauthorizationnumb>
        <drugdosagetext>50 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530357-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103893</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>80 MG (80 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL (ENALAPRIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530358-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104815</companynumb>
    <primarysource>
      <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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACUILIX (HYDROCHLOROTHIAZIDE, QUINAPRIL)</medicinalproduct>
        <drugauthorizationnumb>20125</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEZAFIBRATE (BEZAFIBRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530359-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>1000MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES SIMPLEX</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530360-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041202709</companynumb>
    <primarysource>
      <qualification>3</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>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>17463</drugauthorizationnumb>
        <drugdosagetext>1200-1600MG DAILY</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE (BENDROFLUMETHIAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C (ASCORBIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN (MULTIVITAMINS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530361-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-FF-00702FF</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>0.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugauthorizationnumb>17407</drugauthorizationnumb>
        <drugdosagetext>3 MG  (MG), IU</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXEN (NICARDIPINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUPRESSYL (URAPIDIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANDATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELESTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530362-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>80 MG QID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530363-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040909</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-BRISTOL-MYERS SQUIBB COMPANY-12697959</companynumb>
    <primarysource>
      <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>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDREA</medicinalproduct>
        <drugdosagetext>1 MG ONCE DAILY  THEN 0.5 MG TWICE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOCYTHAEMIA</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530364-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-12794319</companynumb>
    <primarysource>
      <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>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>INITIAL TX DATE: 05-APR-2001. DOSING INFO NOT REPORTED</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530365-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004ES16531</companynumb>
    <primarysource>
      <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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugindication>HEART TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERL080A</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031128</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530366-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0257</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>120</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AERIUS (DESLORATADINE) ^CLARINEX^ TABLETS</medicinalproduct>
        <drugauthorizationnumb>21165</drugauthorizationnumb>
        <drugdosagetext>20 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEDOLON P TABLETS</medicinalproduct>
        <drugdosagetext>6 TABLETS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIC (RANITIDINE HYDROCHLORIDE) TABLETS</medicinalproduct>
        <drugdosagetext>5 TABLETS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN TABLETS</medicinalproduct>
        <drugdosagetext>1600 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROXITHROMYCIN TABLETS</medicinalproduct>
        <drugdosagetext>300 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFUROXIME</medicinalproduct>
        <drugdosagetext>1000 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530367-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE873009DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
        <drugdosagetext>40 MG 2X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
        <drugdosagetext>40 MG 2X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELOC-ZOC MITE (METOPROLOL SUCCINATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530368-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_25464_2004</companynumb>
    <primarysource>
      <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>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>19221</drugauthorizationnumb>
        <drugdosagetext>1 TAB Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030515</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530369-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>430008P04GBR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugdosagetext>12 MG/M2,  1 IN 1 CYCLE,  INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>20 MG, 5 IN 5 DAYS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
        <drugdosagetext>25 MG/M2, 3 IN 3 DAYS, INTRAVENOUS (NOT OTHERWISE SPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530370-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>230011K04CAN</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAT NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY TRAUMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530372-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>220001N04FRA</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE FRACTURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAIZEN</medicinalproduct>
        <drugauthorizationnumb>19764</drugauthorizationnumb>
        <drugdosagetext>0.2 MG, 1 IN 1 DAYS, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ENDOCRINE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESMOPRESSIN ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORLISTAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUGYNON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXAPINE SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPASMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530373-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARISOPRODOL</medicinalproduct>
        <drugdosagetext>TWICE DAILY ONE PILL</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARISOPRODOL</medicinalproduct>
        <drugdosagetext>TWICE DAILY ONE PILL</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041002</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530374-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12775961</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDREA</medicinalproduct>
        <drugdosagetext>START DATE:  UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL THROMBOCYTHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030910</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030927</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530375-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_25465_2004</companynumb>
    <primarysource></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>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugauthorizationnumb>18998</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugdosagetext>20 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugdosagetext>2.5 MG Q DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLINE SALICYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEBEVERINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERBUTALINE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530376-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE261407DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>18989</drugauthorizationnumb>
        <drugdosagetext>1200-1600MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE (BENDROFLUMETHIAZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C (ASCORBIC ACID)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530377-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003018946</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTRIGLYCERIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABILE BLOOD PRESSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugauthorizationnumb>18422</drugauthorizationnumb>
        <drugdosagetext>1200 MG (600 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>HYPERTRIGLYCERIDAEMIA</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530378-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_25354_2004</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugauthorizationnumb>17794</drugauthorizationnumb>
        <drugdosagetext>15 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATOSIL</medicinalproduct>
        <drugdosagetext>500 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIAN</medicinalproduct>
        <drugdosagetext>8000 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530379-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE753103DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS VIRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>3 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530380-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE777907DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugauthorizationnumb>18989</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROFENID (KETOPROFEN, )</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RULID (ROXITHROMYCIN, )</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530381-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2004-07457</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</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>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTAMINE (DOBUTAMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE (DOPAMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIHYDROCODEINE (DIHYDROCODEINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530382-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102168</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>50670</drugauthorizationnumb>
        <drugdosagetext>500 MG (250 MG, 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDRONEL PMO ^NORWICH EATON^ (CALCIUM CARBONATE, ETIDRONATE DISODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS (ASCORBIC ACID, ERGOCALCIFEROL, FOLIC ACID, NICOTINAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530383-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02100-JPN-04-0281</companynumb>
    <primarysource></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>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugauthorizationnumb>20863</drugauthorizationnumb>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugdosagetext>3 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIDAPRIL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANIDIPINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530384-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2004-07645</companynumb>
    <primarysource></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>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040922</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530385-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE996612JUL04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>13.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTROBAN (MUPIROCIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALCYTE (VALGANICLOVIR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERIN (GLYCEROL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530386-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2004-08264</companynumb>
    <primarysource></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>HEPATIC CIRRHOSIS</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>20030220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530387-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02100-JPN-04-0306</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugauthorizationnumb>20863</drugauthorizationnumb>
        <drugdosagetext>ONE OF 200 MG OR 81 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUDILAST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URAPIDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIASTASE COMBINED DRUG 1</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530388-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-2004-035813</companynumb>
    <primarysource>
      <qualification>1</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>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IATROGENIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOGEN RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX TRAUMATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 370</medicinalproduct>
        <drugauthorizationnumb>20220</drugauthorizationnumb>
        <drugdosagetext>120 ML, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530389-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2004-0017957</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>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINE (BENZODIAZEPINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530390-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2004-07534</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENPROCOUMON (PHENPROCOUMON)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530391-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TOR 2004-0035</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIAL HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FARESTON</medicinalproduct>
        <drugauthorizationnumb>20497</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021031</drugenddate>
        <drugtreatmentduration>294</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FARESTON</medicinalproduct>
        <drugauthorizationnumb>20497</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040331</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530392-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CIP04002015</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLS IN URINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELLS URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugauthorizationnumb>20835</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POVIDONE IODINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLORID-D (MICONAZOLE NITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS (CANDESARTAN CILEXETIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLDACTONE (POTASSIUM CANRENOATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530393-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-2004-034734</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROSCOPE 300 (IOPROMIDE)</medicinalproduct>
        <drugauthorizationnumb>20220</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER (FAMOTIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX (TEPRENONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA (FERROUS CITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVANE (VALSARTAN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530394-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TOR 2004-0036</companynumb>
    <primarysource></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>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FARESTON</medicinalproduct>
        <drugauthorizationnumb>20497</drugauthorizationnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031103</drugenddate>
        <drugtreatmentduration>424</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JU-ZEN-TAI-HO-HU (CHINESE DRUG)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530395-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0303</companynumb>
    <primarysource>
      <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>FEMORAL NECK FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT RANGE OF MOTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR MARKER INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE ORAL AEROSOL  ^VANCERIL^</medicinalproduct>
        <drugauthorizationnumb>17573</drugauthorizationnumb>
        <drugdosagetext>0.15MG QD ORAL AER INH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERBUTALINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530396-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-10870</companynumb>
    <primarysource>
      <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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>40 MG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugdosagetext>40 MG Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530397-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030729</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-343751</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEATORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530398-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04120294</companynumb>
    <primarysource>
      <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>COLITIS ISCHAEMIC</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>20040227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530399-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RENA-10959</companynumb>
    <primarysource>
      <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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MORPHOEA</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>20030401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BELOC ZOK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>300 MG QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOS-EX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EINSALPHA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIGANTOLETTEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHYPNOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530400-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW25143</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIAPHRAGMATIC PARALYSIS</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>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugdosagetext>60 ML DAILY PNEU</drugdosagetext>
        <drugindication>NERVE BLOCK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINA ^LICRA^</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530401-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A001-319-705</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALLORY-WEISS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>5 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VASCULAR DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL (CLOPIDOGREL)</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>PAROXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVI (MULTIVITAMINS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530402-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02428</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFLURIL</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELDENE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530403-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2002-0002836</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.8</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALCOHOL WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENT PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUN SHOT WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYSUBSTANCE ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHONCHI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMATOFORM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORCET-HD</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARIJUANA (CANNABIS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELAFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530404-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE03444</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530405-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004_000079</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF BACTERIA IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANT SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPOCYT</medicinalproduct>
        <drugbatchnumb>03-0102</drugbatchnumb>
        <drugauthorizationnumb>21041</drugauthorizationnumb>
        <drugdosagetext>X1; INTRATHECAL</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>METASTASES TO MENINGES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530406-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP06151</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugdosagetext>1.2 ML DI</drugdosagetext>
        <drugindication>INFILTRATION ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530407-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A001-319-733</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>PLACEBO, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VASCULAR DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARTIA XL (DILTIAZEM)</medicinalproduct>
        <drugdosagetext>300 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000417</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTERIC ASPIRIN (ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRO-DUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530408-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP06123</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GASTRIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugdosagetext>20 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530409-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AC00855</companynumb>
    <primarysource>
      <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>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN CODE NOT BROKEN</medicinalproduct>
        <drugauthorizationnumb>18240</drugauthorizationnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTEN MITIS</medicinalproduct>
        <drugindication>HYPOTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENFEUX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530410-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02417</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugdosagetext>1 DF QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAFORAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>1 G QID IV</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BURINEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIFLOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SURBRONC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EUPRESSYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530411-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415685BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.6173</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETERIC OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
        <drugbatchnumb>285484C</drugbatchnumb>
        <drugdosagetext>30-45 ML, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530412-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24858</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugdosagetext>40 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugdosagetext>40 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLENTY</medicinalproduct>
        <drugdosagetext>15 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WEIGHT CONTROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530413-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP06144</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>6488</drugauthorizationnumb>
        <drugdosagetext>0.3 ML DI</drugdosagetext>
        <drugindication>INFILTRATION ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530414-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB03048</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>0</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>3.32</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TALIPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugauthorizationnumb>19777</drugauthorizationnumb>
        <drugdosagetext>10 MG DAILY TPL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530415-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB03011</companynumb>
    <primarysource></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>QUETIAPINE</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530416-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02958</companynumb>
    <primarysource>
      <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>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>25 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCYCLIDINE HYDROCHLORIDE 2MG TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530417-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-239037</companynumb>
    <primarysource>
      <qualification>5</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROINTESTINAL HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040828</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>OESOPHAGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCTREOTIDE</medicinalproduct>
        <drugindication>VARICES OESOPHAGEAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530418-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AC00902</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD PROLACTIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>200 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTHIADEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNI-TRAUXENE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530419-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW25122</companynumb>
    <primarysource></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>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>20541</drugauthorizationnumb>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530420-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12796009</companynumb>
    <primarysource>
      <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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530421-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AC00933</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOLERANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QRS COMPLEX PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>25 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugdosagetext>225 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530422-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105696</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
        <drugauthorizationnumb>20771</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530423-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02944</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SLEEP PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>150 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530424-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004236567US</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG (10 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EXOSTOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HCL</medicinalproduct>
        <drugindication>BRONCHIECTASIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (VITAMINS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530425-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103955</companynumb>
    <primarysource></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>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530426-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0223</companynumb>
    <primarysource>
      <qualification>1</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>VIRAFERONPEG</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530427-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004094327</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50.3493</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, PRN, ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, PRN, ORAL)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG (81 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugdosagetext>75 (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN NOS (VITAMIN NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE (HYDROCHLOROTHIAZIDE, TRIMTERENE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530428-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1497</companynumb>
    <primarysource>
      <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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELESTAMINE TAB</medicinalproduct>
        <drugauthorizationnumb>14215</drugauthorizationnumb>
        <drugdosagetext>1 TAB ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530429-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-NOVOPROD-240990</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM GROWTH ACCELERATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN SIMPLEXX</medicinalproduct>
        <drugdosagetext>6 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530430-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0203</companynumb>
    <primarysource>
      <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>CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugauthorizationnumb>20762</drugauthorizationnumb>
        <drugdosagetext>NASAL SPRAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>NASAL CONGESTION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530431-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>K200401851</companynumb>
    <primarysource>
      <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>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXANTHEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREFEST(ESTRADIOL, NORGESTIMATE) TABLET</medicinalproduct>
        <drugauthorizationnumb>21040</drugauthorizationnumb>
        <drugdosagetext>1 TABLET, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530432-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>ONCE/DAY</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530433-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0260</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>350 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAPLASTIC ASTROCYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530434-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0208</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>80 MCG SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>900 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (ALBUTEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530435-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
        <drugdosagetext> ONCE A DAY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
        <drugdosagetext> ONCE A DAY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040202</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530436-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02571</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>500 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530437-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>8MG   QD    ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530438-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004PK01774</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHLAMYDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030407</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530439-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409106135</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530440-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75MG    QD    ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75MG    QD    ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERPHENAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530441-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100256</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER CATHETER REPLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MECHANICAL COMPLICATION OF IMPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROLAIDS (MAGNESIUM HYDROXIDE, CALCIUM CARBONATE)</medicinalproduct>
        <drugbatchnumb>59672V</drugbatchnumb>
        <drugdosagetext>1 TABLET 5-6 TIMES QD PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB (CELECOXIB)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL (GLUCOSE MONOHYDRATE, ISPAGHULA HUSK)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530442-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.2658</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>ONE PER DAY   MAR 02- JAN 04    ORAL;  TWO PER DAY   JAN 04-FEB 04   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530443-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409106136</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENITAL BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530444-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102820</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE (MENTHOL, METHYL SALICYLATE, EUCALYPTOL, THYMOL)</medicinalproduct>
        <drugdosagetext>BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS (ASCORIC ACID, BIOTIN, MINERALS NOS, NICOTINIC ACID,</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530445-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409106172</companynumb>
    <primarysource>
      <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>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530446-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>AUC 5     D1 + 8 Q 21 D   INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugdosagetext>50 MG/M2     D1 + 8 Q 21 D    INTRAVENOU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530447-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104176</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE BLACK HAIRY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KAOPECTATE (BISMUTH SUBSALICYLATE)</medicinalproduct>
        <drugbatchnumb>819534103</drugbatchnumb>
        <drugdosagetext>2 TABLESPOONS EVERY FEW HOURS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES (ANTIHYPERTENSIVES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTEROL- AND TRIGLYCERIDE REDUCERS (CHOLESTEROL- AND TRIGLYCERIDE </medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530448-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004028568</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COOL MINT LISTERINE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL)</medicinalproduct>
        <drugbatchnumb>01503L</drugbatchnumb>
        <drugdosagetext>DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DENTAL DISORDER PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS (ASCORBIC ACID, BIOTIN, MINERALS NOS, NICOTINIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530449-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.5</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugdosagetext>60MG   BID  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugdosagetext>20MG  ONCE  INTRAMUSCU</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530450-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409106173</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/2 DAY</drugdosagetext>
        <drugindication>BIPOLAR II DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530451-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>003722</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BARTHOLINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL MYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREXAL (METHOTREXATE)TABLET, 7.5MG</medicinalproduct>
        <drugauthorizationnumb>40385</drugauthorizationnumb>
        <drugdosagetext>15.00 MG, 1/WEEK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEASONALE (LEVONORGESTREL, ETHINYLESTRADIOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530452-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>100 MG   PER DAY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041209</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530453-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP000901</companynumb>
    <primarysource>
      <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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugbatchnumb>P8351</drugbatchnumb>
        <drugauthorizationnumb>75034</drugauthorizationnumb>
        <drugdosagetext>600 MG; TWICE A DAY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZARONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABITRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530454-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AL001733</companynumb>
    <primarysource>
      <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>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EROSIVE OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugauthorizationnumb>74819</drugauthorizationnumb>
        <drugdosagetext>400 MG; QD; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530455-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TRP_0041_2004</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-INDUCED VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugauthorizationnumb>76203</drugauthorizationnumb>
        <drugdosagetext>1200 MG QDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERGEN / INTERFERON ALFACON-1/ INTERMUNE</medicinalproduct>
        <drugdosagetext>15 MCG QDAY SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERGEN /INTERFERON ALFACON-1/ INTERMUNE</medicinalproduct>
        <drugdosagetext>15 MCG QDAY SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530456-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108281</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDORXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530457-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1708</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>74949</drugauthorizationnumb>
        <drugdosagetext>300MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530458-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1675</companynumb>
    <primarysource>
      <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 VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>74949</drugauthorizationnumb>
        <drugdosagetext>225-325MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530459-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108283</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530460-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1709</companynumb>
    <primarysource>
      <qualification>3</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>74949</drugauthorizationnumb>
        <drugdosagetext>450-500MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530461-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1716</companynumb>
    <primarysource>
      <qualification>1</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>74949</drugauthorizationnumb>
        <drugdosagetext>400-450MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530462-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104930</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILE DUCT STONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, 2 IN 1D)</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530463-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1710</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE INJECTABLE SOLUTION</medicinalproduct>
        <drugauthorizationnumb>76077</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANIPENEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMIPROM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530464-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105307</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DELTASONE</medicinalproduct>
        <drugauthorizationnumb>9986</drugauthorizationnumb>
        <drugdosagetext>5 MG QD</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugdosagetext>62.5 MG BID</drugdosagetext>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugdosagetext>325 MG QD</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL)</medicinalproduct>
        <drugdosagetext>500 MG BID</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM CARBONATE0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN (WARFARIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530465-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2004IN00443</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>35</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIMSTAR (CODE NOT BROKEN)</medicinalproduct>
        <drugauthorizationnumb>50429</drugauthorizationnumb>
        <drugdosagetext>2 UNK, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMSTAR (CODE NOT BROKEN) TABLET</medicinalproduct>
        <drugdosagetext>2 UNK, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040805</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530466-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105300</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDORXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530467-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2004BR00495</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLORIDRATO DE FLUOXETINA (NGX) (FLUOXETINE)</medicinalproduct>
        <drugauthorizationnumb>75049</drugauthorizationnumb>
        <drugdosagetext>20 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530468-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409106232</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530469-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108284</companynumb>
    <primarysource>
      <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>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG , 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530470-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE788207DEC04</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOSOCOMIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>16418</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530471-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410106301</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530472-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE239012AUG04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugbatchnumb>26349</drugbatchnumb>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>5 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugbatchnumb>26349</drugbatchnumb>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>5 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE/TRIMETHOPRIM ^DAK^ (SULFAMETHOXAZOLE/TRIMETHOPRIM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530473-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410106303</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530474-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106460</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDORXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530475-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410106304</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530476-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE260807DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVONORGESTREL AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>19192</drugauthorizationnumb>
        <drugdosagetext>4 TABLETS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL (ETHANOL, ,0)</medicinalproduct>
        <drugdosagetext>4 GLASSES OF WINE ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugdosagetext>3 TABLETS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530477-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410106306</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530478-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2002A01109</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOPHTHALMITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION IN AN IMMUNOCOMPROMISED HOST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS OPACITIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugauthorizationnumb>20011</drugauthorizationnumb>
        <drugdosagetext>3.75 MG (3.75 MG, 1 IN 28 D) SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020319</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugdosagetext>80 MG (80 MG, 1 D) PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020404</drugenddate>
        <drugtreatmentduration>253</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530479-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106507</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDORXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530480-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410106316</companynumb>
    <primarysource>
      <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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530481-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>25759</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM PQ INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMBOCOR</medicinalproduct>
        <drugauthorizationnumb>18830</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040808</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040808</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARAN (WARFARIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530482-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977644</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530483-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>29.4838</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENEX</medicinalproduct>
        <drugdosagetext>1/2 PILL  TWICE DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABNORMAL BEHAVIOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENEX</medicinalproduct>
        <drugdosagetext>1/2 PILL  TWICE DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041215</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530484-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TCI2003A04178</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugauthorizationnumb>20011</drugauthorizationnumb>
        <drugdosagetext>3.75 MG (3.75 MG, 1 IN 28 D) SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031029</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE (TABLETS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530485-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </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>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>5MG  DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530486-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977646</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINO ACIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530487-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2004A01004</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugauthorizationnumb>20011</drugauthorizationnumb>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-BENELDOPA (MADOPAR)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530488-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.8957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYELID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE AGEING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WRINKLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugindication>SKIN WRINKLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530489-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A01200406053</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugauthorizationnumb>19908</drugauthorizationnumb>
        <drugdosagetext>10 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530490-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977653</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMMUNICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REPETITIVE SPEECH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABITRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530491-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHALAMO-PITUITARY DISORDERS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAREL</medicinalproduct>
        <drugdosagetext>INHALED  ONCE DAILY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530492-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977670</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530493-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NLWYE273310DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATOMYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>75 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530494-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977681</companynumb>
    <primarysource>
      <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>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG99M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040908</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530495-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43.0917</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>70MG    WEEK ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530496-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PTWYE273810DEC04</companynumb>
    <primarysource></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>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFEXOR XR (VELAFAXINE HYDROCHLORIDE, CAPSULE, EXTENDED RELEASE, 0)</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>75 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530497-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530498-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977687</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANORGASMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF RELAXATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00Z</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG IN THE EVENING</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530499-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE860408DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHINADVIL (IBUPROFEN/PSEUDOEPHEDRINE, TABLET)</medicinalproduct>
        <drugauthorizationnumb>19771</drugauthorizationnumb>
        <drugdosagetext>20 TABLETS DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOICILLIN (AMOXICILLIN, )</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXOMIL (BROMAZEPAM, )</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAUSICALM (DIMEHYDRINATE, )</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530500-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530501-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977706</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530502-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BEWYE263307DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS (SIROLIMUS, TABLET, 0)</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530503-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977712</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530504-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE750203DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>300 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041010</drugenddate>
        <drugtreatmentduration>123</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530505-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977719</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG95R</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530506-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SEWYE271309DEC04</companynumb>
    <primarysource></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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>75 MG 1X PER 1 DAY; 150 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>75 MG 1X PER 1 DAY; 150 MG 1X PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLVON (MIANSERIN HYDROCHLORIDE, , 0)</medicinalproduct>
        <drugdosagetext>60 MG 1X PER 1 DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530507-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977743</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH01P</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>20 MG/TWICE DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530508-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE256003DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, TACTILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEREOTYPIC MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEARFULNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>75MG FREQUENCY UNSPECIFIED; 150MG FREQUENCY UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>75MG FREQUENCY UNSPECIFIED; 150MG FREQUENCY UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530509-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBELLAR ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>57 MG IV   5 DOSES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VLATREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TROPROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530510-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE390411NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>2 MG 1X 1 PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>2 MG 1X 1 PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021106</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530511-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>29852</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CORNEAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOPHTHALMITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BSS PLUS</medicinalproduct>
        <drugauthorizationnumb>20742</drugauthorizationnumb>
        <drugdosagetext>IO</drugdosagetext>
        <drugindication>SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCAINE</medicinalproduct>
        <drugdosagetext>OPHT</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXITROL</medicinalproduct>
        <drugdosagetext>OPHT</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILOXAN</medicinalproduct>
        <drugdosagetext>OPHT</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYLPHRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISCOMET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530512-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-06148BP(1)</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOARSENESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVA ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugauthorizationnumb>20291</drugauthorizationnumb>
        <drugdosagetext>8 PUF (SEE TEXT, 2 PUFFS QID), IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugauthorizationnumb>20291</drugauthorizationnumb>
        <drugdosagetext>8 PUF (SEE TEXT, 2 PUFFS QID), IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLUVASC EYE LUBRICANT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FML EYE OINTMENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530513-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F01200403845</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugauthorizationnumb>19732</drugauthorizationnumb>
        <drugdosagetext>22.5 MG Q3M; SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSPENSION - 22.5 MG</medicinalproduct>
        <drugdosagetext>22.5MG Q3M</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530514-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040722</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A04200400672</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COROTROPE</medicinalproduct>
        <drugauthorizationnumb>20343</drugauthorizationnumb>
        <drugdosagetext>NI; INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530515-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ENT 2004-0210</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMTAN</medicinalproduct>
        <drugauthorizationnumb>20796</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530516-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041008231</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>14.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S MOTRIN COLD(IBUPROFEN/PSEUDEPHEDRINE HCL)SUSPENSION</medicinalproduct>
        <drugauthorizationnumb>21128</drugauthorizationnumb>
        <drugdosagetext>5 ML, 1 IN 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530517-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE266908DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530518-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE219222NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMTUZUMAB OZOGAMICIN (GEMTUZUMAB OZOGAMICIN, INJECTION)</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN (DAUNORUBICIN,, 0)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530519-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041202142</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530520-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEWYE271009DEC04</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 GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROGRADE AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE BITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>75 MG 2X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLIMONORM (ESTRADIOL VALERATE/LEVONORGESTREL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530521-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE766806DEC04</companynumb>
    <primarysource></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>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>200 MG 5X PER 1 WK ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>150 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugdosagetext>10 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSTHYMIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>1 DF DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN (FLUINDIONE,)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN (FLUINDIONE,)</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530522-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-13189BP</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>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugdosagetext>18 MCG (18 MCG), IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITALIS (DIGITALIS PURPUREA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN (OXYGEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT (TRIAMCINOLONE ACETONIDE0</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530523-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9403</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KETONURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ANALYSIS ABNORMAL</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>CYTARABINE</medicinalproduct>
        <drugauthorizationnumb>16763</drugauthorizationnumb>
        <drugdosagetext>100 MG/M2 DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN</medicinalproduct>
        <drugdosagetext>45 MG/M2 DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MDR</medicinalproduct>
        <drugdosagetext>550 MG DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530524-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0402GBR00089</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugauthorizationnumb>21042</drugauthorizationnumb>
        <drugdosagetext>25 MG/DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYETHYLENE GLYCOL 3350</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530525-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0409FIN00017</companynumb>
    <primarysource>
      <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>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXANTHEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATO-LENTICULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>21227</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SYSTEMIC CANDIDA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031017</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>21227</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SYSTEMIC CANDIDA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031114</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>800 MG/TID</drugdosagetext>
        <drugindication>STATUS EPILEPTICUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031103</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSPHENYTOIN SODIUM</medicinalproduct>
        <drugindication>STATUS EPILEPTICUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031103</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugdosagetext>75 MG/DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SYSTEMIC CANDIDA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031014</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>2 MG/BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STATUS EPILEPTICUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFUROXIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARECOXIB SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCURONIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530526-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>WAES 0409USA00443</companynumb>
    <primarysource>
      <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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>20386</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021210</drugenddate>
        <drugtreatmentduration>436</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>20386</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030415</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>20386</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030722</drugenddate>
        <drugtreatmentduration>98</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>20386</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530527-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-US2004-08250</companynumb>
    <primarysource>
      <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>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530528-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F01200403849</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN - SOLUTION - 80 MG</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>80 MG 1/WEEK INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL - SOLUTION - 3200 MG</medicinalproduct>
        <drugdosagetext>3200 MG 1/WEEK INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBOFLAVIN - 800 MG</medicinalproduct>
        <drugdosagetext>800 MG 1/WEEK</drugdosagetext>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB - SOLUTION - 5 MG/KG</medicinalproduct>
        <drugdosagetext>5 MG/KG Q2W INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE (LEVOTHYROXINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRENDIPIN (NITRENDIPINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530529-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12545</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>182.0285</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTIONS INVOLUNTARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISUDYNE</medicinalproduct>
        <drugbatchnumb>01764B</drugbatchnumb>
        <drugauthorizationnumb>21119</drugauthorizationnumb>
        <drugdosagetext>6 ML DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROGISEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530530-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F04200400309</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>20839</drugauthorizationnumb>
        <drugdosagetext>450 MG ONCE / 75 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>20839</drugauthorizationnumb>
        <drugdosagetext>450 MG ONCE / 75 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041128</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>300 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041128</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL (BISOPROLOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZID (HYDROCHLOROTHIAZIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530531-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A02200403540</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPANCREATIC FLUID COLLECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>20839</drugauthorizationnumb>
        <drugdosagetext>75 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040718</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMIX - (TAMSULOSIN HYDROCHLORIDE) - CAPSULE PR - 0.4 MG</medicinalproduct>
        <drugdosagetext>0.4 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040718</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT - (BUDESONIDE/FORMOTEROL) - POWDER</medicinalproduct>
        <drugdosagetext>RESPIRATORY (INHALATION)</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040718</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT - (BUDESONIDE/FORMOTEROL) - POWDER</medicinalproduct>
        <drugdosagetext>RESPIRATORY (INHALATION)</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040718</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530532-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>430031M04USA</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.5964</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTRICHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1 IN 3 MONTHS,INTRAVNEOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530533-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A04200401052</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUENSYL - (HYDROXYCHLOROQUINE SULFATE) - TABLET - 200 MG</medicinalproduct>
        <drugauthorizationnumb>9768</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugindication>POLYARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530534-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A02200403558</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA MACROCYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STILNOX - (ZOLPIDEM) - TABLET - 10 MG</medicinalproduct>
        <drugauthorizationnumb>19908</drugauthorizationnumb>
        <drugdosagetext>10 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030224</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030227</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030224</drugenddate>
        <drugtreatmentduration>82</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORLAX - (MACROGOL) - POWDER - 10 G</medicinalproduct>
        <drugdosagetext>30 G QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030224</drugenddate>
        <drugtreatmentduration>53</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR - (ABACAVIR, ZIDOVUDINE, LAMIVUDINE) - TABLET</medicinalproduct>
        <drugdosagetext>1 DF BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030218</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530535-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>9205</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARBOHYDRATE ANTIGEN 19-9 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARCINOEMBRYONIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>89519</drugauthorizationnumb>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>89519</drugauthorizationnumb>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530536-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0357567A</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B VIRUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE (LAMIVUDINE)</medicinalproduct>
        <drugauthorizationnumb>20564</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDINAVIR SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530537-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0358749A</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOALVEOLAR LAVAGE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CAVITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY MONILIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugauthorizationnumb>20564</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELFINAVIR MESYLATE (NELFINAVIR MESYLATE)</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530538-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>B0359098A</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530539-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041105281</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1300 MG OTHER</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN (DOMPERIDONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530540-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC041241623</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </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>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530541-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK LEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE DIET</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530542-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC041241662</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1650 MG OTHER</drugdosagetext>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530543-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530544-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_041105315</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>2000 MG/ 1 OTHER</drugdosagetext>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530545-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530546-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004090620</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>0.25 MG (0.25 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100 MG (100 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugdosagetext>(1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530547-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL 20MG/ M2 AVENTIS</medicinalproduct>
        <drugdosagetext>37 MG/IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>260 MG/IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB PRN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGHEN PRN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530548-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041205301</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CATECHOLAMINES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORD BLOOD TRANSPLANT THERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REVERSIBLE POSTERIOR LEUKOENCEPHALOPATHY SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugauthorizationnumb>14103</drugauthorizationnumb>
        <drugindication>NEUROBLASTOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRARUBICIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530549-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2001073441FR</companynumb>
    <primarysource>
      <qualification>1</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (QD), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOLSIDOMINE (MOLSIDOMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530550-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KCL 30MEQ BID AND ALTACE R 10MG DAILY</medicinalproduct>
        <drugdosagetext>30 MEQ BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugdosagetext>10 MG DAILY</drugdosagetext>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530551-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_040503184</companynumb>
    <primarysource>
      <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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>300 UG OTHER</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040518</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530552-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041004753</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugauthorizationnumb>14103</drugauthorizationnumb>
        <drugdosagetext>1.5 MG OTHER</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PINORUBIN (PIRARUBICIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXAN 9RITUXIMAB0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER (FAMOTIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN R 9STREPTOCOCCUS FAECALIS0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISODINE (POVIDONE-IODINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530554-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101.8</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE 200MG TABLETS</medicinalproduct>
        <drugdosagetext>200 MG TABLETS DAILY</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530555-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_0410205300</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACILLUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE AMBULATORY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUTIS LAXA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONIC CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugauthorizationnumb>14103</drugauthorizationnumb>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530556-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041205328</companynumb>
    <primarysource>
      <qualification>2</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>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530557-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041205298</companynumb>
    <primarysource>
      <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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OSMOLARITY INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugauthorizationnumb>14103</drugauthorizationnumb>
        <drugindication>GERM CELL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOPRESSIN  INJECTION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530558-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>136.0791</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>60 MG DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>60 MG DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530559-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041205295</companynumb>
    <primarysource>
      <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>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2 OTHER</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530560-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.4108</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOTRET</medicinalproduct>
        <drugbatchnumb>1362420</drugbatchnumb>
        <drugdosagetext>40 MG QOD  ORAL   ; 80 MG  ALTERNATE QOD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041209</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530561-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.9363</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041214</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530562-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>23.587</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041214</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530563-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041105260</companynumb>
    <primarysource>
      <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>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULOMUCOCUTANEOUS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugauthorizationnumb>60180</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530564-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103901</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRESS (PRAZOSIN)</medicinalproduct>
        <drugauthorizationnumb>19775</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugdosagetext>10 MG (1 D)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530565-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530566-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104942</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPERAZON (SULBACTAM, CEFOPERAZONE)</medicinalproduct>
        <drugauthorizationnumb>50551</drugauthorizationnumb>
        <drugdosagetext>1 GRAM (1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530567-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.1626</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION FIBROSIS - LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THORACIC VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>100 MG/M2  WEEKLY X 3 INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>AUC 6  ONCE Q 4 WEEKS INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040526</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530568-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108874</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLTERODINE (TOLTERODINE)</medicinalproduct>
        <drugauthorizationnumb>20771</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLTERODINE (TOLTERODINE)</medicinalproduct>
        <drugauthorizationnumb>20771</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLTERODINE (TOLTERODINE)</medicinalproduct>
        <drugauthorizationnumb>20771</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040226</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530569-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYPHILIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>10MG  DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530570-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0141</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VESTIBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTALLINE (GENTAMICIN SULFATE) INJECTABLE SOLUTION</medicinalproduct>
        <drugauthorizationnumb>50039</drugauthorizationnumb>
        <drugdosagetext>160 MG QD INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PROSTATE INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030708</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530571-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.36</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugdosagetext>300MG  TID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19851001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530572-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SGB1-2004-00427</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY RESTENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE STOOLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XAGRID (NAGRELIDE HYDROCHLORIDE)CAPSULE</medicinalproduct>
        <drugauthorizationnumb>20333</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>ESSENTIAL THROMBOCYTHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XAGRID (NAGRELIDE HYDROCHLORIDE)CAPSULE</medicinalproduct>
        <drugauthorizationnumb>20333</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>ESSENTIAL THROMBOCYTHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XAGRID (NAGRELIDE HYDROCHLORIDE)CAPSULE</medicinalproduct>
        <drugauthorizationnumb>20333</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>ESSENTIAL THROMBOCYTHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XAGRID (NAGRELIDE HYDROCHLORIDE)CAPSULE</medicinalproduct>
        <drugauthorizationnumb>20333</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>ESSENTIAL THROMBOCYTHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XAGRID (NAGRELIDE HYDROCHLORIDE)CAPSULE</medicinalproduct>
        <drugauthorizationnumb>20333</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>ESSENTIAL THROMBOCYTHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XAGRID (NAGRELIDE HYDROCHLORIDE)CAPSULE</medicinalproduct>
        <drugauthorizationnumb>20333</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>ESSENTIAL THROMBOCYTHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XAGRID (NAGRELIDE HYDROCHLORIDE)CAPSULE</medicinalproduct>
        <drugauthorizationnumb>20333</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>ESSENTIAL THROMBOCYTHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECTOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COAPROVEL (HYDROCHLOROTHIAZIDE, IRBESARTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROVEL (IRBESARTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCTOLOG (TRIMEBUTINE, RUSCOGENIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEXAQUINE (THIAMINE HYDROCHLORIDE, QUININE BENZOATE, MELALEUCA VIRIDIF</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530573-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530574-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FABR-10879</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLOMERULOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</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>20011101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530575-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0002</companynumb>
    <primarysource>
      <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>IMPLANT SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT RANGE OF MOTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugauthorizationnumb>20911</drugauthorizationnumb>
        <drugdosagetext>0.15MG DAILY INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERBUTALINE</medicinalproduct>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530576-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>150 MG BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530577-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></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>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530578-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004081549</companynumb>
    <primarysource>
      <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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN HEARING LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20882</drugauthorizationnumb>
        <drugdosagetext>1500 MG (300 MG, 5 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLECAINIDE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530579-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.8555</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>2000MG IV WEEKLY 7 WKS THEN, DAY 1, 8, 15 Q 4WKS</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>2000MG IV WEEKLY 7 WKS THEN, DAY 1, 8, 15 Q 4WKS</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>2000MG IV WEEKLY 7 WKS THEN, DAY 1, 8, 15 Q 4WKS</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>2000MG IV WEEKLY 7 WKS THEN, DAY 1, 8, 15 Q 4WKS</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>2000MG IV WEEKLY 7 WKS THEN, DAY 1, 8, 15 Q 4WKS</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040624</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>2000MG IV WEEKLY 7 WKS THEN, DAY 1, 8, 15 Q 4WKS</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>2000MG IV WEEKLY 7 WKS THEN, DAY 1, 8, 15 Q 4WKS</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040708</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>2000MG IV WEEKLY 7 WKS THEN, DAY 1, 8, 15 Q 4WKS</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>2000MG IV WEEKLY 7 WKS THEN, DAY 1, 8, 15 Q 4WKS</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>2000MG IV WEEKLY 7 WKS THEN, DAY 1, 8, 15 Q 4WKS</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>2000MG IV WEEKLY 7 WKS THEN, DAY 1, 8, 15 Q 4WKS</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>2000MG IV WEEKLY 7 WKS THEN, DAY 1, 8, 15 Q 4WKS</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>2000MG IV WEEKLY 7 WKS THEN, DAY 1, 8, 15 Q 4WKS</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>2000MG IV WEEKLY 7 WKS THEN, DAY 1, 8, 15 Q 4WKS</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>2000MG IV WEEKLY 7 WKS THEN, DAY 1, 8, 15 Q 4WKS</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>2000MG IV WEEKLY 7 WKS THEN, DAY 1, 8, 15 Q 4WKS</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>2000MG IV WEEKLY 7 WKS THEN, DAY 1, 8, 15 Q 4WKS</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>2000MG IV WEEKLY 7 WKS THEN, DAY 1, 8, 15 Q 4WKS</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>2000MG IV WEEKLY 7 WKS THEN, DAY 1, 8, 15 Q 4WKS</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>2000MG IV WEEKLY 7 WKS THEN, DAY 1, 8, 15 Q 4WKS</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>2000MG IV WEEKLY 7 WKS THEN, DAY 1, 8, 15 Q 4WKS</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530580-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102982</companynumb>
    <primarysource>
      <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>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031008</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530581-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>8 MG ONE DAILY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530582-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105910</companynumb>
    <primarysource>
      <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>PHENYTOIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>84349</drugauthorizationnumb>
        <drugdosagetext>325 MG (325 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530583-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104980</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 WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE AGEING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugauthorizationnumb>19949</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALORON (TILIDINE)</medicinalproduct>
        <drugdosagetext>100 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530584-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>40 MGN Q.O.W.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>7.5 MG WEEKLY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530585-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105719</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE VIA BREAST MILK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUSTRAL (SERTRALINE)</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530586-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILAFON</medicinalproduct>
        <drugdosagetext>4 MG X1 OR X2 A NIGHT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990826</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530587-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041105265</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>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugauthorizationnumb>60180</drugauthorizationnumb>
        <drugindication>SPONDYLITIS</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugauthorizationnumb>60180</drugauthorizationnumb>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530588-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBS041116046</companynumb>
    <primarysource>
      <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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC ISCHAEMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILLARY REFLEX IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530589-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.1261</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>25 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINBLASTINE SULFATE</medicinalproduct>
        <drugdosagetext>6 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLEOMYCIN</medicinalproduct>
        <drugdosagetext>10 U/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DTIC-DOME</medicinalproduct>
        <drugdosagetext>375 MG/M2 IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530590-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104717</companynumb>
    <primarysource>
      <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>GLASGOW COMA SCALE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugauthorizationnumb>10392</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugdosagetext>140 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530591-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102932</companynumb>
    <primarysource>
      <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>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030213</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530592-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.05</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>650 MG/M2 WK/ IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>400 MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP PRN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530593-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>044-0981-M000002</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STERNAL INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN (WARFARIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL (NICORANDIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERIL TRINITRATE PATCH (GLYCERIL TRINITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530594-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>18.1439</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>15 MG CAPSULE ORALLY DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABNORMAL BEHAVIOUR</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>15 MG CAPSULE ORALLY DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530595-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004213751FR</companynumb>
    <primarysource>
      <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>HYPOGAMMAGLOBULINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>50467</drugauthorizationnumb>
        <drugdosagetext>(CTCLE 2), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFPODOXIME PROXETIL TABLET (CEFPODOXIME PROXETIL) (CEFPODOXIME PROXET</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>(CYCLE 2), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>1.89 MG (CYCLE 2), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE SODIUM SULFOBENZOATE (PREDNISOLONE SODIUM SULFOBENZOATE)</medicinalproduct>
        <drugdosagetext>(CYCLE 2), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOXACIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE (FEOFIBRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530596-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISAPRIDE</medicinalproduct>
        <drugdosagetext>7 MG QID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISAPRIDE</medicinalproduct>
        <drugdosagetext>7 MG QID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTESTINAL HYPOMOTILITY</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARNITINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS / VIT C</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530597-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004228034FR</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHLAMYDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COOMBS DIRECT TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATO-LENTICULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUMPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOPLASMA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETICULOCYTE COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROLOGY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPHEROCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFPODOXIME PROXETIL</medicinalproduct>
        <drugauthorizationnumb>50675</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFUROXAZIDE (NIFUROXAZIDE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXILASE-BACITRACINE (ALPHA-AMYLASE BACTERIAL, BACITRACIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIXOCORTOL PIVALATE (TIXOCORTOL PIVALATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE (DOMPERIDONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SMECTA/OLD FORM/ (ALUMINIUM HYDROXIDE-MAGNESIUM CARBONATE GEL, ALUMINI</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530598-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004241756NO</companynumb>
    <primarysource>
      <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>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, QD), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBYL-ENTEROSOLUBILE (ACETYLSALICYLIC ACID, MAGNESIUM OXIDE)</medicinalproduct>
        <drugdosagetext>160 MEQ (160 MG, QD), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE (ESOMEPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL (CANDESARTAN CILEXETIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530599-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.2971</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUMATRIPTAN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XENADRINE -OTC-</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALESSE -BCP-</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530600-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004072527</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPERAZON (CEFOPERAZONE, SULBACTAM)</medicinalproduct>
        <drugauthorizationnumb>50551</drugauthorizationnumb>
        <drugdosagetext>2 GRAM (2 IN 1 D), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040918</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530601-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.2762</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>37.5MG  HS</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041216</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530602-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105550</companynumb>
    <primarysource>
      <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>50670</drugauthorizationnumb>
        <drugdosagetext>500 MG (500 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPRAZINONE HYDROCHLORIDE (EPRAZINONE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBROXOL HYDROCHLORIDE (AMBROXOL HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530603-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.0906</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>L-TRYPTOPHAN</medicinalproduct>
        <drugdosagetext>500 MG DAILY</drugdosagetext>
        <drugindication>SOMNOLENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19950101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530604-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_040904602</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1400 MG OTHER</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530605-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE_041114649</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIA URINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE SODIUM INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YENTREVE (DULOXETINE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>STRESS INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YENTREVE (DULOXETINE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>URINARY INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530606-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.7913</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugdosagetext>200 MG EVERYDAY  ; 100 MG EVERYDAY</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugdosagetext>200 MG EVERYDAY  ; 100 MG EVERYDAY</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530607-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBS041115990</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530608-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041004921</companynumb>
    <primarysource>
      <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>ABDOMINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>800 MG/1 WEEK</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030729</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530609-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>10MG  DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530610-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041105201</companynumb>
    <primarysource>
      <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>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD OSMOLARITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OSMOLARITY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE SODIUM INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530611-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA_041107495</companynumb>
    <primarysource>
      <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>XIGRIS</medicinalproduct>
        <drugindication>SEPSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOPRESSORS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530612-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.7038</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>835MG X 4 DAYS INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>125.25 MG  X 1 DAY INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530613-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA_041207513</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>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugdosagetext>24 UG/KG/HR</drugdosagetext>
        <drugindication>SEPSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530614-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_040904695</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CERVIX CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>90 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530615-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.9874</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugdosagetext>15MG  DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041216</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530616-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBS041115977</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>30</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugbatchnumb>A061375</drugbatchnumb>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>18 MG</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530617-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.3075</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>1 PUFF TWICE DAILY RESPIRATORY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVLITE BIRTH CONTROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530618-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE_041114808</companynumb>
    <primarysource>
      <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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>900 MG</drugdosagetext>
        <drugindication>BRONCHIAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530619-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.6162</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugdosagetext>400MG  DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CELLULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530620-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_040603337</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LINEAR IGA DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ALKALOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugauthorizationnumb>60180</drugauthorizationnumb>
        <drugdosagetext>500 MG/1 DAY</drugdosagetext>
        <drugindication>POSTOPERATIVE INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugauthorizationnumb>60180</drugauthorizationnumb>
        <drugdosagetext>500 MG/1 DAY</drugdosagetext>
        <drugindication>WOUND INFECTION STAPHYLOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICCILLIN FOR INJECTION (AMPICILLIN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILASTATIN SODIUM W/IMIPENEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530621-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DELAYED RECOVERY FROM ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMURON</medicinalproduct>
        <drugbatchnumb>804441</drugbatchnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041216</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530622-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.5129</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENILE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL COLD AND SINUS</medicinalproduct>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugindication>WHEEZING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530623-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC041241645</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugdosagetext>24 UG/KG/HR</drugdosagetext>
        <drugindication>MULTI-ORGAN FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugdosagetext>24 UG/KG/HR</drugdosagetext>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPENEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEICOPLANIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMIFENTANIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INYESPRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORADRENALINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530624-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>11.3399</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEPTRA</medicinalproduct>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040514</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530625-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041105111</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugauthorizationnumb>14103</drugauthorizationnumb>
        <drugindication>RHABDOMYOSARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYCAMTIN (TOPOTECAN HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530626-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBS040915629</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>39</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>READING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>FF4H76A</drugbatchnumb>
        <drugauthorizationnumb>21017</drugauthorizationnumb>
        <drugdosagetext>31 U DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOMIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530627-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_041105333</companynumb>
    <primarysource>
      <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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>2.1 G/1 OTHER</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IKOREL (NICORANDIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INNOHEP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC (LYSINE ASPIRIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOPRAL (OMEPRAZOLE RATIOPHARM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR (SIMVASTATIN RATIOPHARM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530628-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041205299</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BINOCULAR EYE MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REVERSIBLE POSTERIOR LEUKOENCEPHALOPATHY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugauthorizationnumb>14103</drugauthorizationnumb>
        <drugindication>NON-HODGKIN'S LYMPHOMA STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530629-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041205315</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530630-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBS041216062</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>DEPRESSED MOOD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMATINIB MESILATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530631-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_040102438</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERMAX</medicinalproduct>
        <drugauthorizationnumb>19385</drugauthorizationnumb>
        <drugdosagetext>2250 UG DAY</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530632-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0281560-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.37</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYPTORCHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELFINAVIR MESILATE</medicinalproduct>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE W/LAMIVUDINE</medicinalproduct>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530633-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0283043-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CUTANEOUS VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZECLAR TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHOLCODINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TROXERUTINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530634-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-04P-028-0283111-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC ANTIVIRAL TREATMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030820</drugenddate>
        <drugtreatmentduration>121</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC ANTIVIRAL TREATMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030820</drugenddate>
        <drugtreatmentduration>121</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC ANTIVIRAL TREATMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030820</drugenddate>
        <drugtreatmentduration>121</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530635-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_041105339</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>1 DSG FORM DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040322</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROVAMYCINE (SPIRAMYCIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOPRAL (OMEPRAZOLE RATIOPHARM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSANXIA (PRAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRICANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGIZONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530636-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0283055-00</companynumb>
    <primarysource></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>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</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>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530637-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-ABBOTT-04P-153-0282754-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOLLICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REDUCTIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSMOTIC LAXATIVE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-INFLAMMATORY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530638-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_041105329</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugauthorizationnumb>19640</drugauthorizationnumb>
        <drugdosagetext>0.935 MG OTHER</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530639-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0282855-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPACET 100</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSEUDOEPHEDRINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530640-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030709</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-03P-028-0224185-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYODERMA GANGRENOSUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030603</drugenddate>
        <drugtreatmentduration>965</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021215</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021228</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030128</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLPADEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030110</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530641-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>K200400849</companynumb>
    <primarysource>
      <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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>19901</drugauthorizationnumb>
        <drugdosagetext>5MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugtreatmentduration>1460</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530642-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0283040-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE W/LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINTERFERON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG ABUSER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530643-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0282948-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530644-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0264698-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530645-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0283265-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IRON INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPRANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040809</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530646-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>K200401871</companynumb>
    <primarysource>
      <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>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEPTRA</medicinalproduct>
        <drugauthorizationnumb>17376</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTAZ</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADENOSINE TRIPHOSPHATE(ADENOSINE TRIPHOSPHATE)</medicinalproduct>
        <drugdosagetext>TIW</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBRAMYCIN SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530647-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ABBOTT-04P-150-0281036-00</companynumb>
    <primarysource></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>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN INFANT DEATH SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030221</drugenddate>
        <drugtreatmentduration>73</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030221</drugenddate>
        <drugtreatmentduration>73</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030221</drugenddate>
        <drugtreatmentduration>73</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530648-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ABBOTT-04P-229-0280382-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPILIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPILIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530649-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0282872-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>PATCH</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>WHEEZING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530650-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0281016-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
        <drugtreatmentduration>226</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPANTHYL</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>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</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>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INYESPRIN INYECTABLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530651-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>430019M04DEU</companynumb>
    <primarysource></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>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugdosagetext>28 MG, 1 IN 1 CYCLE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530652-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0282876-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</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>FOLIC ACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530653-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-04P-062-0282848-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN G INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXANTHEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENPROCOUMON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENPROCOUMON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530654-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-04P-167-0278729-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA 40 MG/ 0.8 ML PRE-FILLED SYRINGE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA 40 MG/ 0.8 ML PRE-FILLED SYRINGE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040512</drugenddate>
        <drugtreatmentduration>239</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROTEINURIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDENDRONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530655-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0031</companynumb>
    <primarysource>
      <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugauthorizationnumb>50039</drugauthorizationnumb>
        <drugindication>ENDOCARDITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530656-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0283044-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</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>CLAVULIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530657-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040526</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0262162-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISLOCATION OF JOINT PROSTHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EYE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTAO</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>223</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENDEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</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>CALCITRIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALOXIFENE HCL</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530658-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THYR-10159</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYROGEN</medicinalproduct>
        <drugauthorizationnumb>20898</drugauthorizationnumb>
        <drugdosagetext>0.9 MG QD IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DIAGNOSTIC PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>80 MG NA</drugdosagetext>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENANTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDALIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530659-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_041105330</companynumb>
    <primarysource>
      <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 UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES PALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530660-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0282396-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</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>20040701</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530661-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030828</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-03P-167-0231242-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL NOSE MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL VALPROATE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW SET EARS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIPPLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER DEVELOPMENTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRABISMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPILIM TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIGABATRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530662-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041004963</companynumb>
    <primarysource>
      <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 PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONALON (ALENDRONIC ACID)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530663-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108697</companynumb>
    <primarysource>
      <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>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
        <drugauthorizationnumb>50440</drugauthorizationnumb>
        <drugdosagetext>750 MG</drugdosagetext>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-GLUTAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530664-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0280120-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ALVEOLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
        <drugtreatmentduration>237</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA-ALANINE</medicinalproduct>
        <drugindication>HOT FLUSH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040626</drugenddate>
        <drugtreatmentduration>77</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530665-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0279605-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIPRANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTRIVA</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>HYDRALAZINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAPROLOL XL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORACIT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN ALFA</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILGRASTIM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530666-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108686</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFACLOR</medicinalproduct>
        <drugauthorizationnumb>50521</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530667-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE_041114805</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALOXIFENE HCL</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530668-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC041241612</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugbatchnumb>FF4E37E</drugbatchnumb>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>36 U DAY</drugdosagetext>
        <drugindication>GESTATIONAL DIABETES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041128</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530669-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020327</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0365440A</companynumb>
    <primarysource>
      <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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530670-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20021210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0388857A</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAINFUL DEFAECATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRONEX</medicinalproduct>
        <drugdosagetext>1MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>20MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORCET-HD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENESTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000825</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530671-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0441716A</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
        <drugdosagetext>10MG IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
        <drugdosagetext>5MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KDUR</medicinalproduct>
        <drugdosagetext>10MEQ PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>.4MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530672-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040319</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0504257A</companynumb>
    <primarysource>
      <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>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530673-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040416</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0507439A</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040413</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530674-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0515589A</companynumb>
    <primarysource>
      <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>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</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>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>100MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530675-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0518052A</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84.1</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUN SHOT WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICOLOGIC TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530676-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200420673BWH</companynumb>
    <primarysource>
      <qualification>1</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>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>2.5MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugdosagetext>400MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BCG VACCINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugdosagetext>1G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>650MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>6MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530677-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004030413</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMMUNICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIPRASIDONE (CAPS) (ZIPRASIDONE)</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIPRASIDONE (CAPS) (ZIPRASIDONE)</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIPRASIDONE (CAPS) (ZIPRASIDONE)</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIPRASIDONE (CAPS) (ZIPRASIDONE)</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIPRASIDONE (CAPS) (ZIPRASIDONE)</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN 9BIPERIDEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE (LEVOMEPROMAZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPRAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIPRASIDONE (ZIPRASIDONE0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530678-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106431</companynumb>
    <primarysource>
      <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>BRONCHOPULMONARY ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBLITERATIVE BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugauthorizationnumb>9987</drugauthorizationnumb>
        <drugindication>HEART AND LUNG TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugindication>HEART AND LUNG TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugindication>HEART AND LUNG TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS (TACROLIMUS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530679-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0528438A</companynumb>
    <primarysource>
      <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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MURDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA, PARANOID TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530680-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004107888</companynumb>
    <primarysource>
      <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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDENALIN (DOXAZOSIN)</medicinalproduct>
        <drugdosagetext>2 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN (VALSARTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IFENPRODIL TARTRATE (IFENPRODIL TARTRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROAGE SODIUM (VALPROATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENIDIPINE HYDROCHLORIDE (BENIDIPINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL (ALFACALCIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE 9CALCIUM CARBONATE0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530681-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0531300A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>100MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530682-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103872</companynumb>
    <primarysource>
      <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>CANDIDA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>19949</drugauthorizationnumb>
        <drugdosagetext>400 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEFOPAM HYDROCHLORIDE (NEFOPAM HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIENAM (CILASTATIN, IMIPENEM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN-FRACTION, SODIUM SALT (HEPARIN-FRACTION, SODIUM SALT)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBROXOL (AMBROXOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530683-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-GLAXOSMITHKLINE-A0533835A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRACEPTION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMEBUTINE</medicinalproduct>
        <drugindication>GASTRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530684-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535191A</companynumb>
    <primarysource>
      <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>ANALGESIC DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALCOHOL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED VACCINE TRIAL MEDICATION</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PROPHYLAXIS</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>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530685-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0535639A</companynumb>
    <primarysource>
      <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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOAMING AT MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STARING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>2G FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugdosagetext>200MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugdosagetext>250MG IN THE MORNING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugdosagetext>500MG AT NIGHT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530686-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200113058BWH</companynumb>
    <primarysource>
      <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>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANIC ACID</medicinalproduct>
        <drugdosagetext>800MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010823</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPERACILLIN + TAZOBACTAM</medicinalproduct>
        <drugdosagetext>3.375G FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABDOMINAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010820</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOCALCAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530687-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200111878BWH</companynumb>
    <primarysource>
      <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>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN + CLAVULANIC ACID</medicinalproduct>
        <drugdosagetext>800MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010619</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPERACILLIN + TAZOBACTAM</medicinalproduct>
        <drugdosagetext>3.375G FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABDOMINAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010613</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010625</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010625</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530688-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536385A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugdosagetext>450MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530689-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536505A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530690-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536584A</companynumb>
    <primarysource>
      <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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <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>4530691-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GLAXOSMITHKLINE-A0536928A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugdosagetext>12.5MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOCORDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530692-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537271A</companynumb>
    <primarysource>
      <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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530693-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0537488A</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</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>DEXEDRINE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530694-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537532A</companynumb>
    <primarysource>
      <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>CORONARY ARTERY SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530695-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537534A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530696-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537540A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530697-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020220</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0262149A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE REDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
        <drugdosagetext>960MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020211</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020210</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020210</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORCEVAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011018</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530698-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102203</companynumb>
    <primarysource>
      <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>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugauthorizationnumb>20322</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>VAGINAL CANDIDIASIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530699-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-GLAXOSMITHKLINE-B0319394A</companynumb>
    <primarysource>
      <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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPULSIVE BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY ASPHYXIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL AVOIDANT BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031209</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530700-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0344071A</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPERSONALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEREALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031016</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530701-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0346864A</companynumb>
    <primarysource>
      <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>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIRUBIN CONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040604</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040604</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
        <drugdosagetext>2U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040604</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONON</medicinalproduct>
        <drugdosagetext>4U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>2U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACLODIN</medicinalproduct>
        <drugdosagetext>2U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040604</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAIBOKU-TO</medicinalproduct>
        <drugdosagetext>3U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040602</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIYA BM</medicinalproduct>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROENTERITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040604</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITICOLINE</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATP</medicinalproduct>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN</medicinalproduct>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530702-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0349633A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTRIGLYCERIDAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>6MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAGID</medicinalproduct>
        <drugdosagetext>700MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530703-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0349691A</companynumb>
    <primarysource>
      <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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugdosagetext>2PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugdosagetext>2PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>RHINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDEPINE RETARD</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>100MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030624</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530704-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_25435_2004</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYSUBSTANCE ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL ASSAULT VICTIM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
        <drugauthorizationnumb>17794</drugauthorizationnumb>
        <drugdosagetext>DF  IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANNABIS</medicinalproduct>
        <drugdosagetext>DF  IN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530705-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0350094A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMMUNICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>7</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>20040806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENALIN</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARNAL</medicinalproduct>
        <drugdosagetext>.2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUP-4</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROGENIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugdosagetext>250MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TECIPUL</medicinalproduct>
        <drugdosagetext>.99UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530706-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GLAXOSMITHKLINE-B0351173A</companynumb>
    <primarysource>
      <qualification>2</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>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>150MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040630</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530707-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0356962A</companynumb>
    <primarysource>
      <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>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugdosagetext>250MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530708-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0357147A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULCERLMIN</medicinalproduct>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EATING DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>6G PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EATING DISORDER</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>HARNAL</medicinalproduct>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UBRETID</medicinalproduct>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSURIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUDIOMIL</medicinalproduct>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPALMON</medicinalproduct>
        <drugdosagetext>3U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERIPHERAL VASCULAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530709-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_25466_2004</companynumb>
    <primarysource>
      <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>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugauthorizationnumb>18998</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530710-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GLAXOSMITHKLINE-B0357282A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM Q WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
        <drugdosagetext>600MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARVEZIDE</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530711-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0357464A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>36</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>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOANING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>.5MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFZON</medicinalproduct>
        <drugdosagetext>100MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORCAM</medicinalproduct>
        <drugdosagetext>4MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530712-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>700473</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugauthorizationnumb>21321</drugauthorizationnumb>
        <drugdosagetext>1.5 L; QD; INTRAPERITONEAL</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER</medicinalproduct>
        <drugdosagetext>2000 ML; INTRAPERITONEAL</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUANABENZ ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILNIDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM HYDRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D-CHLORPHENIRAMINE MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINASTINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALESION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530713-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0357480A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugdosagetext>50ML TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040905</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>60MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIART</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASCITES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>HYPERAMMONAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULCERLMIN</medicinalproduct>
        <drugdosagetext>2.001G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLAKAY</medicinalproduct>
        <drugdosagetext>45MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVACT</medicinalproduct>
        <drugdosagetext>12.45G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCYRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE A</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASCITES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASCITES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAURINE</medicinalproduct>
        <drugdosagetext>3.06G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>54G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOLEBAN</medicinalproduct>
        <drugdosagetext>200ML PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIRUDOID</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA K</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON</medicinalproduct>
        <drugdosagetext>20UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530714-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0357684A</companynumb>
    <primarysource>
      <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>MYOCLONIC EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>25MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEPSAL</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYOCLONUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GARDENAL</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530715-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0357949A</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR SULPHATE</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>6CAP PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030620</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530716-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0358120A</companynumb>
    <primarysource>
      <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>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPHREN</medicinalproduct>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATINE</medicinalproduct>
        <drugdosagetext>510MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>234MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECOTIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugdosagetext>.25UNIT THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN</medicinalproduct>
        <drugdosagetext>6UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SMECTA</medicinalproduct>
        <drugdosagetext>3UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530717-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0358225A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGRAPHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>500MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESIDRI</medicinalproduct>
        <drugdosagetext>1U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATRIX</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530718-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0358307A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UTERINE CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530719-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GLAXOSMITHKLINE-B0358442A</companynumb>
    <primarysource>
      <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>BRAIN SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXYCILLIN + CLAVULANIC ACID</medicinalproduct>
        <drugdosagetext>1G UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LARYNGOTRACHEITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530720-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GLAXOSMITHKLINE-B0359241A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLDOPA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530721-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359865A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530722-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359875A</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>8MG IN THE MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75MG IN THE MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>40MG AT NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEZAFIBRATE</medicinalproduct>
        <drugdosagetext>400MG IN THE MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>125MCG IN THE MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1G TWICE PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530723-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359966A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>148</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugdosagetext>200MCG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530724-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359987A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530725-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0360052A</companynumb>
    <primarysource>
      <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>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041024</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TINELAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRECIPITATED CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530726-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0360196A</companynumb>
    <primarysource>
      <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>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROPINIROLE</medicinalproduct>
        <drugdosagetext>19MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugdosagetext>700MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugdosagetext>20MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530727-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-UK-01233UK</companynumb>
    <primarysource>
      <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 CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530728-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0360621A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLEDOMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEDIEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>1.5G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANATON</medicinalproduct>
        <drugdosagetext>3U PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530729-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0361796A</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530730-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0361798A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRYPTANOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530731-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004JP002109</companynumb>
    <primarysource>
      <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>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER PLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFAMEZIN</medicinalproduct>
        <drugdosagetext>1.1G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugdosagetext>350MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANEST</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPHEDRINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530732-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-GLAXOSMITHKLINE-B0361897A</companynumb>
    <primarysource>
      <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>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NARAMIG</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530733-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0361915A</companynumb>
    <primarysource>
      <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>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ESCHERICHIA URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARLODEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530734-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200404673</companynumb>
    <primarysource>
      <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>ERYTHROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LARGE INTESTINE CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOVORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530735-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-02388</companynumb>
    <primarysource>
      <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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFUHEXAL</medicinalproduct>
        <drugdosagetext>250MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041128</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530736-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-02395</companynumb>
    <primarysource>
      <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>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXAT</medicinalproduct>
        <drugdosagetext>200MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530737-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>00A25225</companynumb>
    <primarysource>
      <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>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN TANNATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINIUM SILICATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC RESISTANT LACTIC ACID BACTERIAE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530738-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GLAXOSMITHKLINE-B0362084A</companynumb>
    <primarysource>
      <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>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL</medicinalproduct>
        <drugdosagetext>1MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530739-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0044880A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXANTHEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '250'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION BACTERIAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040824</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530740-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-066-0282769-00</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>40147</drugauthorizationnumb>
        <drugdosagetext>200 MG/M2 ONCE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>400 MG/M2, ONCE, INTRAVENOUS</drugdosagetext>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAMNITOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530741-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0045466A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>2TAB PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530742-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0045479A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugdosagetext>1002MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040820</drugenddate>
        <drugtreatmentduration>127</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>850MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-HYPERLIPIDEMIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530743-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-066-0282770-00</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>40147</drugauthorizationnumb>
        <drugdosagetext>200 MG/M2, ONCE,  INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>400 MG/M2, ONCE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANNITOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530744-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE02931</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.9963</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IATROGENIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE BURNING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUNBURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISUDYNE</medicinalproduct>
        <drugauthorizationnumb>21119</drugauthorizationnumb>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040715</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530745-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TNZES200400133</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDACTYLY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INNOHEP</medicinalproduct>
        <drugauthorizationnumb>20484</drugauthorizationnumb>
        <drugdosagetext>10500 IU</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>ANTIPHOSPHOLIPID SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADIRO (ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTOFERRINA (IRON SUCCINYL-PROTEIN COMPLEX)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530746-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004US001469</companynumb>
    <primarysource>
      <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>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION FUNGAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugauthorizationnumb>50740</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugauthorizationnumb>50740</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040722</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530747-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004EU002156</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>1.30 MG , BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>150 MG, QID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>80.00 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPRIL (ENALAPRIL MALEATE)</medicinalproduct>
        <drugdosagetext>1.40 MG , BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSOFALK (URSODEOXYCHOLIC ACID0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVITE (FOLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIMAGON (CALCIUM CARBONATE0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORANOL (VITAMINS NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIOCARD /GFR/MAGNESIUM ASPARTATE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX (ACICLOVIR SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530748-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003JP007334</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>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530749-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004EU001306</companynumb>
    <primarysource>
      <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>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FK506(TACROLIMUS CAPSULES) CAPSULE</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FK506(TACROLIMUS CAPSULES) CAPSULE</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT (MYOCPHENOLATE MOFETIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530750-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004US001470</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>2.50 MG, UID/QD, ORAL; 1.00 MG, UID/QD; 1.00 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS (SIROLIMUS)</medicinalproduct>
        <drugdosagetext>1.50 MG, BID, 20.70 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530751-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004JP001797</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>38.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>3.00 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030708</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL (OMEPRAZOLE) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO (URSODEOXYCHOLIC ACID) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAKTAR (SULFAMETHOXAZOLE, TRIMETHOPRIM) TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN (FLUCONAZOLE) CAPSULE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAALOX (MAGNESIUM HYROXIDE, ALUMINIUM HYDROXIDE GEL) POWDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULCERLMIN (SUCRALFATE) POWDER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE-ALPHA (ALFACALCIDOL) TABLET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530752-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004JP001455</companynumb>
    <primarysource>
      <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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50709</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRAMIN (SULFAMETHOXAZOLE, TRIMETHOPRIM) INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACICLOVIR (ACICLOVIR) INJECTION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530753-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BE16293</companynumb>
    <primarysource>
      <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>RETINAL PIGMENT EPITHELIOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISUDYNE</medicinalproduct>
        <drugauthorizationnumb>21119</drugauthorizationnumb>
        <drugindication>CHOROIDAL NEOVASCULARISATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530754-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>209172</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>0</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA(RITUXIMAB) CONC FOR SOLUTION FOR INFUSION</medicinalproduct>
        <drugdosagetext>580 MG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN (DOXORUBICIN, DOXORUBICIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTICOAGULANTS (ANTICOAGULANTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530755-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-09-0034</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>33</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugauthorizationnumb>20641</drugauthorizationnumb>
        <drugdosagetext>5 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECONASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530758-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2004BR00495</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLORIDRATO DE FLUOXETINA (NGX)(FLUOXETINE)</medicinalproduct>
        <drugauthorizationnumb>75049</drugauthorizationnumb>
        <drugdosagetext>20 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530760-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041205</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE_040814207</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALNA (TAMSULOSIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530763-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_041005130</companynumb>
    <primarysource>
      <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>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL (BROMAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPT-A-MYL (HEPTAMINOL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STABLON (TIANEPTINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530765-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SHI_00006_2004</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>13</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEIMAX</medicinalproduct>
        <drugauthorizationnumb>50686</drugauthorizationnumb>
        <drugdosagetext>90 MG QDAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040616</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530767-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBS041115876</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>27</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOURETTE'S DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>25 MG DAY</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530769-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBS040915669</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>803</patientonsetageunit>
      <patientweight>3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030624</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530772-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_040904404</companynumb>
    <primarysource>
      <qualification>1</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>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>5 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHYPNOL (FLUNITRAZEPAM EG)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN (ZOPICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530774-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBS040514966</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLEEN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530776-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041105032</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>15 MG DAY</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONSTAN (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTAN (BROMAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHYPNOL (FLUNITRAZEPAM EG)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530777-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBS041115869</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASILAR ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIANOPIA HOMONYMOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOEMBOLIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041003</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530779-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBS040915586</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLOFAC (MEBEVERINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLPADEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAVAMEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOGADON (NITRAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDOCAL (CALCIUM GLUBIONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNARIZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530781-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041004923</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugbatchnumb>E0569DA</drugbatchnumb>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG/ 1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JEOASE (PROTEASE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPEN (ETODOLAC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASLON (IRSOGLADINE MALEATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMOTONIN (CALCITONIN, SALMON)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530782-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041105018</companynumb>
    <primarysource>
      <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>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPAMIT (NIFEDIPINE PA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL (ALFACALCIDOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EURODIN (ESTAZOLAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530784-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE_041114652</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA BLOCKING AGENTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530786-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_040603415</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2 OTHER</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040413</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUVOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER (FAMOTIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARAPLATIN (CARBOPLATIN SANOFI-SYNTHELABO)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530787-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041105210</companynumb>
    <primarysource>
      <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>HAEMOLYTIC URAEMIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530789-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC041141397</companynumb>
    <primarysource>
      <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>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE-IV (GEMCITABINE )</medicinalproduct>
        <drugbatchnumb>FFUK81D</drugbatchnumb>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1600 MG/2 OTHER</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530791-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041004858</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILE DUCT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1200 MG OTHER</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL - FOR INFUSION (GRANISETRON HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530793-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105532</companynumb>
    <primarysource>
      <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>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNORING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDENALIN (DOXAZOSIN)</medicinalproduct>
        <drugauthorizationnumb>19668</drugauthorizationnumb>
        <drugdosagetext>AROUND 56 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACE INHIBITOR NOS (ACE INHIBITOR NOS)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530795-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106432</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugauthorizationnumb>9987</drugauthorizationnumb>
        <drugdosagetext>1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>1 GRAM (1 GRAM, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZYLPENICILLIN (BENZYLPENICILLIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530797-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC041241636</companynumb>
    <primarysource>
      <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>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DESQUAMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>15 MG DAY</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURAZEPAM</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>4530798-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC041241633</companynumb>
    <primarysource>
      <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>GASTROINTESTINAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC DILATATION OF COLON</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOZINAN /NET/ (LEVOMEPROMAZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530799-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE_041114783</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>35 MG DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLAMIDON (METHADONE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530800-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBS041216068</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL (CARBAMAZEPINE RIVOPHARM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIMAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530802-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC041241679</companynumb>
    <primarysource>
      <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>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>5 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>5 MG DAY</drugdosagetext>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530806-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC041241617</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAECAL (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530807-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR_040904866</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GALACTORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTROPHY BREAST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>5 MG/1 DAY</drugdosagetext>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040709</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530809-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC041041041</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANT SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG DAY</drugdosagetext>
        <drugindication>FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIRALUD (TIZANIDINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNONORM-GENERICON (MAGNESIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTANIL (BROMAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530811-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC041241669</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY RELATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>AGGRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPILIM (VALPROATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIXOL ACUPHASE (ZUCLOPENTHIXOL ACETATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530812-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW25142</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>34</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXEMESTANE</medicinalproduct>
        <drugdosagetext>25 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530813-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BE16292</companynumb>
    <primarysource>
      <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>CHORIORETINAL SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOROIDAL NEOVASCULARISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL PIGMENT EPITHELIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISUDYNE</medicinalproduct>
        <drugauthorizationnumb>21119</drugauthorizationnumb>
        <drugindication>CHOROIDAL NEOVASCULARISATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530815-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BE16294</companynumb>
    <primarysource>
      <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>RETINAL PIGMENT EPITHELIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISUDYNE</medicinalproduct>
        <drugauthorizationnumb>21119</drugauthorizationnumb>
        <drugindication>CHOROIDAL NEOVASCULARISATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530817-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BE16291</companynumb>
    <primarysource>
      <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>CHOROIDAL NEOVASCULARISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL PIGMENT EPITHELIOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISUDYNE</medicinalproduct>
        <drugauthorizationnumb>21119</drugauthorizationnumb>
        <drugindication>CHOROIDAL NEOVASCULARISATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530819-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EWC041241615</companynumb>
    <primarysource>
      <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>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORSTEO (TERIPARATIDE)</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530821-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0412108773</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530823-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBS041216051</companynumb>
    <primarysource>
      <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>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530824-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-122-0282599-00</companynumb>
    <primarysource>
      <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 PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTOTHAL</medicinalproduct>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IOPROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCCINYLCHOLINE CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMIFENTANIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530825-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-056-0282469-00</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULATION FACTOR V LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTOTHAL</medicinalproduct>
        <drugdosagetext>175 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESFLURANE</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>0.75 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUCCINYLCHOLINE CHLORIDE</medicinalproduct>
        <drugdosagetext>60 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISATRACURIUM</medicinalproduct>
        <drugdosagetext>7 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXCARBAZEPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530826-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0282437-00</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASOCONSTRICTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDOCAINE HCL</medicinalproduct>
        <drugbatchnumb>16120 3F</drugbatchnumb>
        <drugauthorizationnumb>40057</drugauthorizationnumb>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530827-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-034-0283194-00</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASOCONSTRICTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDOCAINE HCL</medicinalproduct>
        <drugbatchnumb>16120 3F</drugbatchnumb>
        <drugauthorizationnumb>40057</drugauthorizationnumb>
        <drugdosagetext>INJECTION</drugdosagetext>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530828-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-066-0282753-00</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>40147</drugauthorizationnumb>
        <drugdosagetext>200 MG/M2, ONCE, INTRAVENOUS/DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>400 MG/M2, ONCE, INTRAVENOUS/DAY 1 - DAY 2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANNITOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530829-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004IM000978</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFERGEN</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530830-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24608</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PROCEDURE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530831-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA04190</companynumb>
    <primarysource>
      <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>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFACLOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530832-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0412GBR00083</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530833-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01585</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL BOWEL ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530834-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20021120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0002495</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION SKIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DESQUAMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHYOL</medicinalproduct>
        <drugauthorizationnumb>20221</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RADIOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHYOL</medicinalproduct>
        <drugauthorizationnumb>20221</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RADIOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISCOUS XYLOCAINE (LIDOCAINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAALOX (MAGNESIUM HYDROXIDE, ALUMINIUM HYDROXIDE GEL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE (HYDROCODONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARRASYN OINTMENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAFINE OINTMENT (PROPOPYLENE GLYCOL, TROLAMINE, ETHYLENE GLYCOL MONOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530835-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0412USA00582</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY ASPHYXIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOCIN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFCAPENE PIVOXIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTI-INFECTIVE THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PONTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFACLOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTI-INFECTIVE THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530836-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01144</companynumb>
    <primarysource>
      <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>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STEROID THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530837-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410106317</companynumb>
    <primarysource>
      <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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530838-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020904</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0209USA00350</companynumb>
    <primarysource>
      <qualification>1</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>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-CARDIAC CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST LAMINECTOMY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIMPLE PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO POSITIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530839-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0002492</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>111.5849</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BURNING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION SKIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHYOL</medicinalproduct>
        <drugauthorizationnumb>20221</drugauthorizationnumb>
        <drugdosagetext>500 MG, 5 IN 1 WK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RADIOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FE SO4 (FERROUS SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KCL (POTASSIUM CHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERI-COLACE (DOCUSATE SODIUM, CANSANTHRANOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAALOX (MAGNESIUM HYDROXIDE, ALUMINIUM HYDROXIDE GEL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530840-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410106318</companynumb>
    <primarysource>
      <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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530841-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0002500</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHYOL</medicinalproduct>
        <drugauthorizationnumb>20221</drugauthorizationnumb>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTROPRAZOLE (PANTOPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE (DEXTROPROPOXYPHENE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLOXYLIN SUSPENSION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOE VERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530842-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA00863</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530843-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01356</companynumb>
    <primarysource>
      <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>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530844-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410106319</companynumb>
    <primarysource>
      <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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530845-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01200</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN (AZATHIOPRINE)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530846-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004PK02075</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPARTMENT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BURNING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBOTHROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NESACAINE</medicinalproduct>
        <drugauthorizationnumb>9435</drugauthorizationnumb>
        <drugdosagetext>40 ML DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530847-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0301USA02085</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST WALL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED ACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBULA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL FUNCTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATIC FEVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL ODOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VEIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEO-BI-FLEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HOT FLUSH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030103</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530848-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410106342</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG99M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530849-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-MERCK-0409THA00019</companynumb>
    <primarysource>
      <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>ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPODYSTROPHY ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIXIVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030408</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530850-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01590</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530851-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA02813</companynumb>
    <primarysource>
      <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>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL STOMA COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530852-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210967</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>300 MG, Q4W</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR (FLUITCASONE PROPIONATE, SALMETEROL XINAFOATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530853-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410106596</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530854-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA04066</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOCYSTEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBROXOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUANABENZ ACETATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530855-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0304USA00805</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLEX PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERNATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL PITTING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL POLYPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020514</drugenddate>
        <drugtreatmentduration>376</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010504</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530856-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410106598</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530857-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200420498BWH</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.3</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATO-LENTICULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPIDER NAEVUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugindication>CHRONIC SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
        <drugindication>CHRONIC SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HCL</medicinalproduct>
        <drugindication>CHRONIC SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA-D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530858-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410106599</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530859-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0304USA00750</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>128</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIMB INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE STRAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530860-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-MERCK-0412ITA00026</companynumb>
    <primarysource>
      <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>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVANZ</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CELLULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041204</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANRENOATE POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICERGOLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAZINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN LYSINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530861-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24885</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530862-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410106601</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG99M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530863-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0205USA02191</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOMALACIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISPLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL SEPTUM DEVIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL TURBINATE HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOSE DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THORACIC VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010729</drugenddate>
        <drugtreatmentduration>138</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SWELLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010729</drugenddate>
        <drugtreatmentduration>138</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530864-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW25072</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LARYNGOSPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>200 MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPOGLYCEMIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530865-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410106697</companynumb>
    <primarysource>
      <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>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530866-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US014389</companynumb>
    <primarysource>
      <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>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugauthorizationnumb>20747</drugauthorizationnumb>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugdosagetext>8000 UG QD BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugdosagetext>1600 UG QID BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
        <drugdosagetext>100 MG BID</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530867-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410106698</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530868-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0205USA02103</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACQUIRED CLAW TOE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMARTHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFENTANIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530869-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW25127</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530870-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977755</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG IN THE MORNING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTHMA INHALER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530871-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210973</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR (FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL STEROIDS (ORAL STEROIDS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530872-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977780</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530873-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW25117</companynumb>
    <primarysource>
      <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>NOLVADEX</medicinalproduct>
        <drugauthorizationnumb>17970</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530874-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977787</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS NOS (MULTIVITAMINS NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530875-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210639</companynumb>
    <primarysource>
      <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>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALSE NEGATIVE LABORATORY RESULT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>1/MONTH</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530876-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977812</companynumb>
    <primarysource>
      <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>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530877-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004IM000981</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIMMUNE</medicinalproduct>
        <drugdosagetext>50 UG; TIW</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFERGEN</medicinalproduct>
        <drugdosagetext>17 UG; QD</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>1000 UG; QD</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530878-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977829</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7ZG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530879-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977836</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INITIAL INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530880-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200420673BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117.9352</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM POOR R-WAVE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPIL FIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QRS AXIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHYTHM IDIOVENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21277</drugauthorizationnumb>
        <drugdosagetext>400 MG, ONCE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>2.5 MG, ONCE, RESPIRATORY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugdosagetext>ONCE, RESPIRATORY (INHALATION)</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugdosagetext>1 G, ONCE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugdosagetext>650 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BCG (BACILLE CALMETTE-GUERIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZMACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530881-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977845</companynumb>
    <primarysource>
      <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>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530882-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200420902BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>30 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530883-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977868</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530884-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414838BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>500 MG, Q1HR, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTHACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530885-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977872</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530886-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977887</companynumb>
    <primarysource>
      <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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530887-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415734BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BAYER CHILDRENS ORAGE (ACETYLSALICYLIC ACID)</medicinalproduct>
        <drugdosagetext>81 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NISENTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVATAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530888-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200411935BWH</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APALLIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECEREBRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAL BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>400 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMIG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUDAFED S.A.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530889-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW14883</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100.6985</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugauthorizationnumb>19962</drugauthorizationnumb>
        <drugdosagetext>25 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530890-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040903</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977460</companynumb>
    <primarysource>
      <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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530891-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24015</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.11</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530892-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040903</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977474</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530893-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200408192</companynumb>
    <primarysource>
      <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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRANIOPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugindication>FACIAL SPASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>35 UNITS ONCE IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>FACIAL SPASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040228</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>37.5 UNITS ONCE IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>FACIAL SPASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020813</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCYAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONODOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRATEST H.S.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530894-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977481</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7FG97T</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7FG97T</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530895-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040903</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977496</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN (ZOLPIDEM TARTRAT)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530896-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20011218</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-MERCK-0112BRA07917</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011201</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530897-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0302USA00102</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>118</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACROCHORDON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISPLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEBORRHOEIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990816</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530898-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977502</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG99M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 IN THE MORNING</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530899-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0402USA00066</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTION TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-CARDIAC CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE BITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011211</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530900-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977524</companynumb>
    <primarysource>
      <qualification>3</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530901-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004IM000866</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAFERON (A643_INTERFERON ALFACON-1)</medicinalproduct>
        <drugdosagetext>12 MU, QW; SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODEOXYCHOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530902-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977529</companynumb>
    <primarysource>
      <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>ESSENTIAL TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00Z</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530903-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004229762JP</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>20571</drugauthorizationnumb>
        <drugdosagetext>140 MG (QD), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM LEVOFOLINATE (CALCIUM LEVOFOLINATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE 9SODIUM BICARBONATE0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODEOXYCHOLIC ACID(URSODEOXYCHOLIC ACID)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530904-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977530</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALCOHOL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530905-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003IM001113</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAFERON (A643_INTERFERON ALFACON-1)</medicinalproduct>
        <drugdosagetext>12 MU; QOD; SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031010</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530906-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977544</companynumb>
    <primarysource>
      <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>ANORGASMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530907-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104632</companynumb>
    <primarysource>
      <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>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>(200MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530908-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977599</companynumb>
    <primarysource>
      <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>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY HESITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530909-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105294</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZULFIDINE EN-TABS</medicinalproduct>
        <drugauthorizationnumb>7073</drugauthorizationnumb>
        <drugdosagetext>1000 MG (500 MG, 1 IN 2 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIZOLAM (ETIZOLAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULINDAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEPRENONE  (TEPRENONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORGAN LYSATE, STANDARDIZED (ORGAN LYSATE, STANDARDIZED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIOVASCULAR SYSTEM DRUGS (CARDIOVASCULAR SYSTEM DRUGS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICHLORMETHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530910-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105214</companynumb>
    <primarysource>
      <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>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (1 IN 1 D)</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCT)</medicinalproduct>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530911-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105744</companynumb>
    <primarysource>
      <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>AORTIC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABERGOLINE TABLET (CABERGOLINE)</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>9 MG (DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530912-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004107978</companynumb>
    <primarysource>
      <qualification>2</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>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID SOLUTION, STERILE (LINEZOLID)</medicinalproduct>
        <drugauthorizationnumb>21131</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NOCARDIOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530913-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_24299_2004</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.9467</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECONOMIC PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDIZEM CD</medicinalproduct>
        <drugauthorizationnumb>20062</drugauthorizationnumb>
        <drugdosagetext>540 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDIZEM CD</medicinalproduct>
        <drugdosagetext>360 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAPROX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN SODIUM</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530914-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00868</companynumb>
    <primarysource>
      <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</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE NONUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL PRURITUS FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACROCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICYCLOMINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN ES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN ES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRIXIVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRIXIVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESYREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990816</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530915-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MK200412-0008-2</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>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugauthorizationnumb>40050</drugauthorizationnumb>
        <drugdosagetext>100 MG TABLETS, 58 TABS'WEEKEND OF 7/28/2003</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530916-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0337</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugauthorizationnumb>21165</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE AGENT (NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTEROL LOWERING AGENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530917-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-10-0376</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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPRISONMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTION SICKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL ASSAULT VICTIM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530918-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210477</companynumb>
    <primarysource>
      <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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION ENTEROCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>400 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CPT-11 (IRINOTECAN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX (PANTOPRAOZLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANZEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530919-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00786</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>129</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC OUTLET OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-CARDIAC CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST THROMBOTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTRICTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENOSYNOVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000517</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530920-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20010717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SGBI-2001-00012</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGRYLIN</medicinalproduct>
        <drugauthorizationnumb>20333</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530921-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-05079</companynumb>
    <primarysource>
      <qualification>3</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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLCHICINE (WATSON LABORATORIES) (COLCHICINE) TABLET, 0.6MG</medicinalproduct>
        <drugdosagetext>2 FIRST TIME, + 1 AFTER, 10 TOTAL, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROPACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530922-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24696</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.7</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL THROMBOSIS LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAT EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>650 MG/M2 Q12H</drugdosagetext>
        <drugindication>RECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530923-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0307USA00402</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADJUSTMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADRENAL ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE CELL CARCINOMA OF THE RESPIRATORY TRACT STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLEX SYMPATHETIC DYSTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010704</drugenddate>
        <drugtreatmentduration>143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010704</drugenddate>
        <drugtreatmentduration>143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530924-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00925</companynumb>
    <primarysource>
      <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 ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERIAL EMBOLUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID BRUIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESSENTIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCHROMIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PERITONEAL ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTEBRAL ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPONDYLITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010624</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530925-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040227</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0402USA02038</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011203</drugenddate>
        <drugtreatmentduration>73</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXICET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030111</drugenddate>
        <drugtreatmentduration>799</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530926-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0304USA00870</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>105</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNORING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS STASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010819</drugenddate>
        <drugtreatmentduration>125</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORICIDIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA-D</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WESTCORT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530927-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410394BBE</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMUNEX</medicinalproduct>
        <drugbatchnumb>26N4TK1</drugbatchnumb>
        <drugdosagetext>40 G, Q2WK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROXATRAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530928-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410341BBE</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMUNEX</medicinalproduct>
        <drugbatchnumb>26N3R91</drugbatchnumb>
        <drugdosagetext>5 G, ONCE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPOGAMMAGLOBULINAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMUNEX</medicinalproduct>
        <drugbatchnumb>26N29P1</drugbatchnumb>
        <drugdosagetext>2.5 G, ONCE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPOGAMMAGLOBULINAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMUNEX</medicinalproduct>
        <drugbatchnumb>26N29P1</drugbatchnumb>
        <drugdosagetext>2.5 G, ONCE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPOGAMMAGLOBULINAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLROROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOBRAMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILRINONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VECURONIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORAL HYDRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TPN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN HUMAN ^BERNA^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUBIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYCITRA K ^BAKER NORTON^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARIMUNE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530929-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410390BBE</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMIMUNE N 10%</medicinalproduct>
        <drugdosagetext>30 G, UNK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>IMMUNODEFICIENCY COMMON VARIABLE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530930-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00601</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530931-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA00688</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>110</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHROSCOPIC SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530932-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00373</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021006</drugenddate>
        <drugtreatmentduration>643</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EQUILIN SODIUM SULFATE AND ESTRONE SODIUM SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530933-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0402USA00067</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530934-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>20037197-C624544-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.05</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUTTOCK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>4B7867Q-ANTICOAGULANT SOD CITRATE SOL USP 250 ML</medicinalproduct>
        <drugbatchnumb>C624544</drugbatchnumb>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLASMAPHERESIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530935-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0407USA01739</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASBESTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530936-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00552</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CAUDA EQUINA SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAXOLOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530937-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PAGL/04/11/USA</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUILLAIN-BARRE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANGLOBULIN</medicinalproduct>
        <drugbatchnumb>04588-00047</drugbatchnumb>
        <drugdosagetext>25 G, ONCE, I.V.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GUILLAIN-BARRE SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530938-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0410GBR00173</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530939-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-03868</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BOVINE TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST (BCG - IT (CONNAUGHT)), AVENTIS PASTEUR LTD.</medicinalproduct>
        <drugdosagetext>81.0 MG (81.0 MG)</drugdosagetext>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530940-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-03867</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST (BCG - IT (CONNAUGHT)),AVENTIS PASTEUR LTD.</medicinalproduct>
        <drugdosagetext>81.0 MG</drugdosagetext>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530941-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-MERCK-0410NZL00029</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPRAMINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530942-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA01950</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530943-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040312</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0403USA01342</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WISDOM TEETH REMOVAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010321</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBETA (DIPIVEFRIN HYDROCHLORIDE (+) LEVOBUNOLOL HYDROCHLORIDE)</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530944-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00372</companynumb>
    <primarysource>
      <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>RETINAL VEIN OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERCHLORHYDRIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530945-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-01907</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BOVINE TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST (BCG - IT (CONNAUGHT)), AVENTIS PASTEUR LTD.</medicinalproduct>
        <drugdosagetext>81 MG (81.0 MG)</drugdosagetext>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040504</drugenddate>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROTIZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVIPROSTAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAFTOPIDIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530946-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00407</companynumb>
    <primarysource>
      <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530947-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03361</companynumb>
    <primarysource>
      <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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530948-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA02095</companynumb>
    <primarysource>
      <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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530949-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00562</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>119</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRODIURIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530950-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-02843</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST (BCG - IT (CONNAUGHT)),AVENTIS PASTEUR LTD. LOT NOT REP,I3</medicinalproduct>
        <drugdosagetext>80.0 MG</drugdosagetext>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040712</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXIFLURIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530951-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00275</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040722</drugenddate>
        <drugtreatmentduration>1634</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHIMAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530952-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00469</companynumb>
    <primarysource>
      <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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUNCTATE KERATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URECHOLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530953-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA02301</companynumb>
    <primarysource>
      <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>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JOINT SPRAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JOINT SWELLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530954-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03808</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[COMPOSITION UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530955-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04574</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530956-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12953</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530957-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-MERCK-0412CHE00014</companynumb>
    <primarysource>
      <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>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530958-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA02813</companynumb>
    <primarysource>
      <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>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASILAR MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROSACEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TENDONITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000901</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020801</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERIARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000901</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020801</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN-D</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530959-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03439</companynumb>
    <primarysource>
      <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
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  <safetyreport>
    <safetyreportid>4530960-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420765BWH</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530961-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01205</companynumb>
    <primarysource>
      <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>INCISION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530962-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01088</companynumb>
    <primarysource>
      <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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530963-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01187</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530964-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420767BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTION INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEXUAL DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530965-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-MERCK-0412SWE00014</companynumb>
    <primarysource>
      <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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DIATHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WHIPLASH INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530966-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-MERCK-0412ITA00027</companynumb>
    <primarysource>
      <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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530967-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03842</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530968-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420768BWH</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041003</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530969-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420770BWH</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, PRN, ORAL;  10 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530970-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420771BWH</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>111.1313</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXBAK91</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE CHONDROITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINSENG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-ANXIETY PILL (NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530971-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00008</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>VENTRICULAR ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>170</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
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        <drugstartdate>20040909</drugstartdate>
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        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
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        <medicinalproduct>ASPIRIN</medicinalproduct>
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        <drugstartdate>20000101</drugstartdate>
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      <drug>
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        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
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        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
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        <drugenddate>20040930</drugenddate>
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      <drug>
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        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
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        <drugenddate>20040930</drugenddate>
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      <drug>
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        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
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        <drugenddate>20040930</drugenddate>
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      <drug>
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        <drugstartdate>20040401</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4530972-6</safetyreportid>
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    <transmissiondate>20050328</transmissiondate>
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    <receivedate>20041213</receivedate>
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    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMUNEX</medicinalproduct>
        <drugbatchnumb>26N4J91</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
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        <drugindication>ANTI-PLATELET ANTIBODY</drugindication>
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        <drugstartdate>20041118</drugstartdate>
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      <drug>
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        <medicinalproduct>GAMUNEX</medicinalproduct>
        <drugbatchnumb>26N4J91</drugbatchnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTI-PLATELET ANTIBODY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMUNEX</medicinalproduct>
        <drugbatchnumb>26N3WP1</drugbatchnumb>
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  <safetyreport>
    <safetyreportid>4530973-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
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    <receivedateformat>102</receivedateformat>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>4530974-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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      <qualification>5</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>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>ESCHERICHIA BACTERAEMIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>ESCHERICHIA URINARY TRACT INFECTION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
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        <drugenddate>20030101</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030102</drugstartdate>
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        <drugenddate>20031101</drugenddate>
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  <safetyreport>
    <safetyreportid>4530975-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
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      <qualification>4</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
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        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
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        <drugenddate>20041001</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
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      <drug>
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        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
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  <safetyreport>
    <safetyreportid>4530976-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420774BWH</companynumb>
    <primarysource>
      <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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
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        <drugstartdate>20041001</drugstartdate>
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      <drug>
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        <medicinalproduct>VIAGRA</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICATIONS FOR ARTHRITIS</medicinalproduct>
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  <safetyreport>
    <safetyreportid>4530977-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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      <qualification>4</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
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        <drugindication>BACK PAIN</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
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        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020208</drugstartdate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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  <safetyreport>
    <safetyreportid>4530978-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
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    <receivedateformat>102</receivedateformat>
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    <companynumb>200420777BWH</companynumb>
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      <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>DRUG INEFFECTIVE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
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  <safetyreport>
    <safetyreportid>4530979-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
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    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420781BWH</companynumb>
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      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
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      <drug>
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        <medicinalproduct>COZAAR</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
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  <safetyreport>
    <safetyreportid>4530980-5</safetyreportid>
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      <qualification>5</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>CYANOPSIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
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  <safetyreport>
    <safetyreportid>4530981-7</safetyreportid>
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      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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      <drug>
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        <drugcharacterization>1</drugcharacterization>
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      <qualification>5</qualification>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARTILAGE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530984-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0359983A</companynumb>
    <primarysource>
      <qualification>5</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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MALARONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040820</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530985-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01369</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530986-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01839</companynumb>
    <primarysource>
      <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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530987-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420816BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.3273</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETES MEDICATION (NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530988-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420827BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530989-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01573</companynumb>
    <primarysource>
      <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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530990-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420828BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, TIW, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530991-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410399BBE</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIV INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOATE</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FACTOR IX COMPLEX</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FACTOR VIII (BAXTER) (FACTOR VIII)</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FACTOR IX COMPLEX</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FACTOR VIII (ARMOUR PHARMACEUTICALS) (FACTOR VIII)</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FACTOR IX (ARMOUR PHARMACEUTICALS ) (FACTOR IX)</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FACTOR VIII (AVENTIS BEHRING) (FACTOR VIII)</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FACTOR IX (AVENTIS BEHRING) (FACTOR IX)</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FACTOR VIII</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FACTOR IX COMPLEX</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530992-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01343</companynumb>
    <primarysource>
      <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 DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530993-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01346</companynumb>
    <primarysource>
      <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>ANOREXIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010301</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>4530994-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
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    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01180</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530995-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01328</companynumb>
    <primarysource>
      <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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530996-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01817</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530997-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410400BBE</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIV INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOATE</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FACTOR IX COMPLEX</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FACTOR VIII (BAXTER) (FACTOR VIII)</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FACTOR IX COMPLEX</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FACTOR VIII (ARMOUR PHARMACEUTICALS) (FACTOR VIII)</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FACTOR IX (ARMOUR PHARMACEUTICALS ) (FACTOR IX)</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FACTOR VIII (AVENTIS BEHRING) (FACTOR VIII)</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FACTOR IX (AVENTIS BEHRING) (FACTOR IX)</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FACTOR VIII (ALPHA THERAPEUTICS) (FACTOR VIII)</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FACTOR IX COMPLEX</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530998-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0402USA00065</companynumb>
    <primarysource>
      <qualification>1</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>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEBACEOUS HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4530999-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01535</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531000-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01371</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030407</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531001-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01370</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531002-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410398BBE</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIV INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOATE</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KONYNE</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FACTOR VIII (BAXTER) (FACTOR VIII)</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FACTOR IX COMPLEX</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FACTOR VIII (ARMOUR PHARMACEUTICALS) (FACTOR VIII)</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FACTOR IX (ARMOUR PHARMACEUTICALS) (FACTOR IX)</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FACTOR VIII (AVENTIS BEHRING) (FACTOR VIII)</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FACTOR IX (AVENTIS BEHRING) (FACTOR IX)</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FACTOR VIII (ALPHA THERAPEUTICS) (FACTOR VIII)</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FACTOR IX COMPLEX</medicinalproduct>
        <drugindication>HAEMOPHILIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531003-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0406USA01772</companynumb>
    <primarysource>
      <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>EWING'S SARCOMA METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSMEGEN</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>EWING'S SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010918</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>EWING'S SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010924</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOMIDE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>EWING'S SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010921</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIACIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>EWING'S SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010918</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531004-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01320</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531005-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0412USA00765</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>38</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE RESPIRATORY DISTRESS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE RESPIRATORY DISTRESS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POLYURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531006-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-MERCK-0412THA00003</companynumb>
    <primarysource>
      <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>BACTERIAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040418</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531007-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01359</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531008-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0412USA00293</companynumb>
    <primarysource>
      <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>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEICOPLANIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA STAPHYLOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POLYURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANRENOATE POTASSIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POLYURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>POLYURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531009-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>601656</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>803</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INHIBITING ANTIBODIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVATE (ANTIHEMOPHILIC FACTOR (RECOMBINANT), PLASMA/ ALBUMIN FREE METH</medicinalproduct>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531010-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>601655</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>803</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INHIBITING ANTIBODIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVATE (ANTIHEMOPHILIC FACTOR (RECOMBINANT), PLASMA/ALBUMIN FREE METHO</medicinalproduct>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531011-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0407USA01746</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030201</drugenddate>
        <drugtreatmentduration>373</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531012-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01307</companynumb>
    <primarysource>
      <qualification>5</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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531013-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-MERCK-0412NOR00019</companynumb>
    <primarysource>
      <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>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOCLOBEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531014-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01002</companynumb>
    <primarysource>
      <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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ROTATOR CUFF SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531015-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01372</companynumb>
    <primarysource>
      <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>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531016-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0002523</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>1 IN 30 D, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIQUID IRON  SUPPLEMENT (IRON)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHORPIM (TRIMETHORPIM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531017-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420830BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>148.3262</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXBA9R1</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10-20 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXBA9R1</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10-20 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531018-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-2004-031362</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTRAST MEDIA REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 370</medicinalproduct>
        <drugauthorizationnumb>20220</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>UROGRAPHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040902</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531019-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420831BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.3899</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXB9P1</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXB9P1</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531020-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_25232_2004</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MONO-TILDIEM - SLOW RELEASE</medicinalproduct>
        <drugauthorizationnumb>18602</drugauthorizationnumb>
        <drugdosagetext>200 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531022-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200420838BWH</companynumb>
    <primarysource></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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>20 MG, OW, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531023-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2004-0017578</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPECTRACEF</medicinalproduct>
        <drugauthorizationnumb>21222</drugauthorizationnumb>
        <drugdosagetext>MG, SINGLE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFZON (CEFDINIR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE (CARBOCISTEINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERIACTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531025-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBR-2004-0001411</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>19516</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531026-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AL001522</companynumb>
    <primarysource>
      <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>ARTERIOSPASM CORONARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KADIAN</medicinalproduct>
        <drugauthorizationnumb>20616</drugauthorizationnumb>
        <drugdosagetext>10 MG; X1; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTHACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>150 MG; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531028-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RS004868-F</companynumb>
    <primarysource>
      <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>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORPHYRIA NON-ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORPHYRINS URINE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DI-ANTLAVIC (APOREX)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531030-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>L04-TUR-08102-01</companynumb>
    <primarysource>
      <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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSECUTORY DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugdosagetext>20 MG QD</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531033-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THYR-10181</companynumb>
    <primarysource>
      <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>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROIDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYROGEN</medicinalproduct>
        <drugauthorizationnumb>20898</drugauthorizationnumb>
        <drugdosagetext>0.03 MG ONCE IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>GOITRE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IODINE-131</medicinalproduct>
        <drugdosagetext>30</drugdosagetext>
        <drugindication>GOITRE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531035-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-07-0360</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE MB INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM THORAX ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>60-400 MG ORAL; 600 MG ORAL; 400 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>60-400 MG ORAL; 600 MG ORAL; 400 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>60-400 MG ORAL; 600 MG ORAL; 400 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>6 MIU QD-TIW INTRAMUSCULAR; 6 MIU QD INTRAMUSCULAR; 6 MIU TIW INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>6 MIU QD-TIW INTRAMUSCULAR; 6 MIU QD INTRAMUSCULAR; 6 MIU TIW INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>6 MIU QD-TIW INTRAMUSCULAR; 6 MIU QD INTRAMUSCULAR; 6 MIU TIW INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELOKEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN (LOSARTAN POTASSIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPOVAS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531037-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8007416</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REACTION TO DRUG EXCIPIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugbatchnumb>03D26B</drugbatchnumb>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>2500 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG RESISTANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugbatchnumb>03D26B</drugbatchnumb>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>2500 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugbatchnumb>03H13C</drugbatchnumb>
        <drugdosagetext>1750 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG RESISTANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugbatchnumb>03H13C</drugbatchnumb>
        <drugdosagetext>1750 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugbatchnumb>04D04</drugbatchnumb>
        <drugdosagetext>750 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG RESISTANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugbatchnumb>04D04</drugbatchnumb>
        <drugdosagetext>750 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>1250 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG RESISTANCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>1250 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugbatchnumb>03B12C</drugbatchnumb>
        <drugdosagetext>1250 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG RESISTANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugbatchnumb>03B12C</drugbatchnumb>
        <drugdosagetext>1250 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>1250 MG /D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B1 AND B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRUM  ORAL      LEK</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531040-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8008270</companynumb>
    <primarysource></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>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>1000 MG 2/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FURABID</medicinalproduct>
        <drugdosagetext>100 MG/2D</drugdosagetext>
        <drugindication>CYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>50 MG/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVONORGESTREL AND ETHINYL ESTRADIOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531042-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8008255</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>250 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531044-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>8008254</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
        <drugdosagetext>500 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>225 MG 2/D PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021025</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531046-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEU-2004-0001170</companynumb>
    <primarysource>
      <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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACCIDENT AT WORK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYGESIC 10 MG (OXY CR TAB 10 MG) (OXYCODONE HYDROCHLORIDE) CR TABLET</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>10 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531048-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108882</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLTERODINE (TOLTERODINE)</medicinalproduct>
        <drugauthorizationnumb>20771</drugauthorizationnumb>
        <drugdosagetext>4 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL (ACENOCOUMAROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM (BROMAZEPAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531051-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108891</companynumb>
    <primarysource>
      <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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLTERODINE (TOLTERODINE)</medicinalproduct>
        <drugauthorizationnumb>20771</drugauthorizationnumb>
        <drugindication>HYPERTONIC BLADDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL VALERATE (ESTRADIOL VALERATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531052-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108899</companynumb>
    <primarysource>
      <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>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLTERODINE 9TOLTERODINE)</medicinalproduct>
        <drugauthorizationnumb>20771</drugauthorizationnumb>
        <drugdosagetext>QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASWTATIN (LOVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531055-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410107233</companynumb>
    <primarysource>
      <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>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALATA (DULOXETINE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531058-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105575</companynumb>
    <primarysource>
      <qualification>1</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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLAT AFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALATA (DULOXETINE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIPRASIONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531059-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082607</companynumb>
    <primarysource>
      <qualification>1</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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALATA (DULOXETINE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531060-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004231940FR</companynumb>
    <primarysource>
      <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>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTAZINE (SPIRONOLACTONE, ALTIZIDE)</medicinalproduct>
        <drugdosagetext>1 TBSP (1 TBSP, DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REPAGLINIDE (REPAGLINIDE)</medicinalproduct>
        <drugdosagetext>8 MG (DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASOBRAL (CAFFEINE, DIHYDROERGOCRYPTINE MESILATE)</medicinalproduct>
        <drugdosagetext>2 DOE FORMS (DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITZONE (PIOGLITAZONE0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE MITE  (FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531061-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US087649</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000726</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531062-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082361</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA (DULOXETINE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531063-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03351</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METAMORPHOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>648</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531064-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082319</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA (DULOXETINE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531065-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082222</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA (DULOXETINE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531066-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876848</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531067-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040827</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876850</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG96R</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>SOMNOLENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531068-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102628</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADJUSTMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL THROMBOSIS LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERMITTENT CLAUDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARITAL PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENOPAUSAL SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PODIATRIC EXAMINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC STRESS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF ESTEEM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D)</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROXITHROMYCIN  (ROXITHROMYCIN)</medicinalproduct>
        <drugdosagetext>300 MG (300 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>PHARYNGOLARYNGEAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531069-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876853</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RETIN A (TRETINOIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531070-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101539</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESICS (ANALGESICS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531071-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US087891</companynumb>
    <primarysource></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>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531072-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876881</companynumb>
    <primarysource>
      <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>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531073-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-087-0278862-00</companynumb>
    <primarysource>
      <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>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPARIN-INDUCED THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>5264</drugauthorizationnumb>
        <drugdosagetext>20000 UNIT, DAILY</drugdosagetext>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OZAGREL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EDARAVONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GALENIC / PANIPENEM/BETAMIPROM/</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531074-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876896</companynumb>
    <primarysource>
      <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>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531075-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US088146</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FOLLICLE CENTRE LYMPHOMA, FOLLICULAR GRADE I, II, III</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORPHENADRINE CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531076-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876901</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>79H00Z</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX (ALPRAZOLAM DUM))</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531077-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003IM000831</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA HAEMOPHILUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON GAMMA-1B (INTERFERON GAMMA-1B)</medicinalproduct>
        <drugdosagetext>100 MCG; TIW; SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>553 MG;Q3W;INTRANEOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>273 MG;Q3W;INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531078-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US088453</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531079-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876904</companynumb>
    <primarysource>
      <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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531080-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040827</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US088899</companynumb>
    <primarysource>
      <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>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG,  2 IN 1 WEEKS</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531081-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410649BYL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugdosagetext>200 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAMEZIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531082-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876908</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531083-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US089095</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531084-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876909</companynumb>
    <primarysource>
      <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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531085-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US089319</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 1 IN 1 WEEKS, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531086-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410659BYL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERNILTON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUNRYTHM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLIVAS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOFRANIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUP-4</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARNAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531087-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US090432</companynumb>
    <primarysource></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>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 IN 1 WEEKS, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040823</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531088-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02117</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TADENAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531089-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US090928</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYELITIS TRANSVERSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531090-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041201</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US090935</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER STAGE I</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 IN 1 WEEKS, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531091-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876946</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>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040902</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531092-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004PK02074</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SELOKEN RETARD</medicinalproduct>
        <drugauthorizationnumb>19962</drugauthorizationnumb>
        <drugdosagetext>95 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SELOKEN RETARD</medicinalproduct>
        <drugauthorizationnumb>19962</drugauthorizationnumb>
        <drugdosagetext>95 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TACHYCARDIA PAROXYSMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531093-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24955</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER NECK OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>20 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531094-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082398</companynumb>
    <primarysource>
      <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>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531095-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW25028</companynumb>
    <primarysource>
      <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>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>20541</drugauthorizationnumb>
        <drugdosagetext>1 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531096-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082399</companynumb>
    <primarysource>
      <qualification>3</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531099-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082400</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/ ONCE DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531100-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082402</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STRABISMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531101-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041205</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210908</companynumb>
    <primarysource>
      <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>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM PR SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>8 MG/KG, SINGLE, INTRAVENOUS; 6 MG/KG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>8 MG/KG, SINGLE, INTRAVENOUS; 6 MG/KG, Q3W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN (DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531102-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>211067</companynumb>
    <primarysource>
      <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>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>70 MG, 1/WEEKM INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>1200 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040330</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531104-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082403</companynumb>
    <primarysource>
      <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531105-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082415</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531107-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>R301129-3002-CDN</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE (RAMIPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELTROXIN (LEVOTHYROXINE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531108-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082416</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531110-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082418</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531111-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>Z002-204-0003</companynumb>
    <primarysource>
      <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>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY ASPHYXIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>4 DOSAGE FORMS, 4 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO (ZONISAMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELEGILINE HYDROCHLORIDE(SELEGILINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPS (DROXIDOPA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISOPYRAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531113-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>J081-002-001831</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</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>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>0.25 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX (TEPRENONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN (LOSARTAN POTASSIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYSTANIN (L-CYSTEINE ETHYL ESTER, HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUSTAZOL (CLOPERASTINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531114-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082419</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531116-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A044-002-005357</companynumb>
    <primarysource>
      <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>PSYCHOTIC DISORDER</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>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-COMADOL (PANADEINE CO)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPTAC (PEPTAC)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531117-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A044-002-005333</companynumb>
    <primarysource>
      <qualification>3</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKAEMIA PLASMACYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</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</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>15 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULPHATE ANHYDROUS (FERROUS SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMOL (APOREX)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRALAX (MICROLAX)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531119-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>J081-002-001703</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL CIRCULATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>3 MG, 1 IN 1 D, ORAL; 5 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>3 MG, 1 IN 1 D, ORAL; 5 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</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>DOXAZOSIN MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID (SENNA LEAF)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531121-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082420</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531123-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-IRL-07963-01</companynumb>
    <primarysource>
      <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>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACAMPROSATE</medicinalproduct>
        <drugauthorizationnumb>21431</drugauthorizationnumb>
        <drugdosagetext>7900 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>800 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>2730 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugdosagetext>60 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPRID (SULPIRIDE)</medicinalproduct>
        <drugdosagetext>6400 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugdosagetext>600 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>1200 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>100 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531125-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041215</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-DE-05126BY</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPIL FIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugauthorizationnumb>20228</drugauthorizationnumb>
        <drugdosagetext>IH   LESS THAN 1 DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugdosagetext>400 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
        <drugtreatmentduration>5171</drugtreatmentduration>
        <drugtreatmentdurationunit>807</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>2.5 MG IH  LESS THAN 1 DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>2.5 MG IH  LESS THAN 1 DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugdosagetext>1 G IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
        <drugtreatmentduration>1430</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugdosagetext>650 MG PRN PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BCG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZMACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531127-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AC00748</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>40 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROLEPTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531129-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBS041116039</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531131-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13186</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531132-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP_041004822</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG/1 DAY</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHYPNOL (FLUNITRAZEPAM EG)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531134-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP06160</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARCINOID TUMOUR OF THE DUODENUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC POLYPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugdosagetext>20 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugdosagetext>20 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531136-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02435</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>20578</drugauthorizationnumb>
        <drugdosagetext>10.8 MG Q3MO SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531137-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE06741</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugdosagetext>40 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIATUS HERNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugdosagetext>40 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASILIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAURIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531139-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004PK02088</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUADRIPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugdosagetext>20 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531141-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02980</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugdosagetext>40 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531143-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02470</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LARYNGEAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>20541</drugauthorizationnumb>
        <drugdosagetext>1 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020621</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531144-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02426</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>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>20541</drugauthorizationnumb>
        <drugdosagetext>1 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531146-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG00483</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>VAGINAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>20541</drugauthorizationnumb>
        <drugdosagetext>1 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
        <drugdosagetext>20 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SECTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMAREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROFENID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531148-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02479</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>1 DF DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>1 DF DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG BIWK SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROGEL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVATREX ^LEDERLE^</medicinalproduct>
        <drugdosagetext>7.5 MG WEEK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUPHASTON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531150-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AC00945</companynumb>
    <primarysource>
      <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>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugdosagetext>8 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOLUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531151-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBS040915657</companynumb>
    <primarysource>
      <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>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>20 UG DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531152-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105931</companynumb>
    <primarysource>
      <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>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLIZINE (CYCLIZINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC (DICLOFENAC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL (BISOPROLOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACIDIPINE (LACIDIPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531154-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02322</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC 325</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531157-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-622</companynumb>
    <primarysource>
      <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>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>15 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL (ENALAPRIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531159-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-623</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALLOGENIC BONE MARROW TRANSPLANTATION THERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOHISTIOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531161-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-624</companynumb>
    <primarysource>
      <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>INTESTINAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIANAL ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>7.5 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>200 MG 1X PER 1 MTH, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARCOXIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531163-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-625</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL DNA TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG 2X PER 1 WK, SC   (8 DOSES)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531165-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-626</companynumb>
    <primarysource>
      <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>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>6 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>22 MG 1X PER 1 DAY, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (CORTICOSTEROIDS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531167-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-627</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 DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS FIBROSING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOARSENESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBLITERATIVE BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>15 MG 1X ER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO FOR ETANERCEPT (PLACEBO FOR ETANERCEPT, INJECTION)</medicinalproduct>
        <drugdosagetext>1 DOSE 2X PER 1 WK, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010117</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531169-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEU-2004-0001150</companynumb>
    <primarysource>
      <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>PROTHROMBIN TIME SHORTENED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>40 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST PROCEDURAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
        <drugdosagetext>UNK TABLET,  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COAGULOPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531171-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02368</companynumb>
    <primarysource>
      <qualification>1</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHIOLOALVEOLAR CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>250 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHIOLOALVEOLAR CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE DISKUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRONCHODUAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531173-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2004-034830</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BONE MARROW TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHROPOIESIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
        <drugdosagetext>30 MG, UNK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEMASTINE FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-DECORTIN-H (PREDNISOLONE SODIUM SUCCINATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WOBENZYM (ENZYMES NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531175-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2004-033932</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531176-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-2004-035605</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER IN SITU</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGESTERONE RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-THYROXINE (LEVOTHYROXINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531179-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876963</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY HESITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531180-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-2004-036563</companynumb>
    <primarysource>
      <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>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
        <drugauthorizationnumb>19865</drugauthorizationnumb>
        <drugdosagetext>80 G, 1X/DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TACHYCARDIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531182-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-2004-035821</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKULL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 300</medicinalproduct>
        <drugbatchnumb>42606</drugbatchnumb>
        <drugauthorizationnumb>20220</drugauthorizationnumb>
        <drugdosagetext>100 ML, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM ABDOMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531183-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876968</companynumb>
    <primarysource>
      <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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531185-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410668BYL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RAYNAUD'S PHENOMENON</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPENON (APRINDINE HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>40 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCENOL (ATENOLOL)</medicinalproduct>
        <drugdosagetext>25 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531186-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876988</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SHOOT</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>7.5 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531188-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413331GDS</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>19847</drugauthorizationnumb>
        <drugdosagetext>600 MG, TOTAL DAILY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BACTERIAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFZOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531190-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876993</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531191-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05485</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>500 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>30 FRACTIONS OF 2 GY GIVEN, TOTAL AMOUNT = 60 GY</drugdosagetext>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAPRED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRALYSAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531192-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040877022</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531194-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977050</companynumb>
    <primarysource></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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>SOMNOLENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</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>4531195-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977052</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 20</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531196-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413268GDS</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>118</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>400 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINCOCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYPRODOL ^RIO ETHICALS^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXPIGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN-D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE MITE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531197-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410627BFR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMYOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALTOR (CERIVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20740</drugauthorizationnumb>
        <drugdosagetext>0.3 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESURIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TADENAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPANTHYL ^BRISTOL-MYERS SQUIBB^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOLVON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531198-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410074BYL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>19847</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBENIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531199-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977085</companynumb>
    <primarysource></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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA (DULOXETINE HYDROCHLORIDE)</medicinalproduct>
        <drugbatchnumb>7SH00Z</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZADONE (TRAZODONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531200-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AC00958</companynumb>
    <primarysource>
      <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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-SMALL CELL LUNG CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEFITINIB</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEFITINIB</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTASES TO CENTRAL NERVOUS SYSTEM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEFITINIB</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531201-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977115</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA (DULOXETINE HYDROCHLORIDE)</medicinalproduct>
        <drugbatchnumb>7SG96R</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/ 1 DAY</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOY TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531202-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977132</companynumb>
    <primarysource>
      <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>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA (DULOXETINE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531203-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AC00959</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEFITINIB</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
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        <drugenddate>20030501</drugenddate>
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      <drug>
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        <medicinalproduct>GEFITINIB</medicinalproduct>
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        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTASES TO CENTRAL NERVOUS SYSTEM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
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        <drugenddate>20030501</drugenddate>
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      <drug>
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        <medicinalproduct>GEFITINIB</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
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        <drugenddate>20030501</drugenddate>
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    <safetyreportid>4531204-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP06186</companynumb>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
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      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LERCANIDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4531205-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
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      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG98S</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/ 1 DAY</drugdosagetext>
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      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>4531206-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004PK02076</companynumb>
    <primarysource>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
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  <safetyreport>
    <safetyreportid>4531207-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
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    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082457</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>4531208-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2002SE05879</companynumb>
    <primarysource>
      <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>
      <patientweight>95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>80 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
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        <drugstartdate>20000316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020411</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020412</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLENDIL</medicinalproduct>
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  <safetyreport>
    <safetyreportid>4531209-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041183005</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/ 1 DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531210-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041183007</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/ 1 DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531211-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-13204RO</companynumb>
    <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>PANCREATITIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>76213</drugauthorizationnumb>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANIPENEM W/BETAMIPROM (PANIPENEM)</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>4531212-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041183009</companynumb>
    <primarysource>
      <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>NAUSEA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/ 1 DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531213-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0408105079</companynumb>
    <primarysource>
      <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>DIZZINESS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
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        <drugenddate>20040801</drugenddate>
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  <safetyreport>
    <safetyreportid>4531214-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
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      <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>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
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        <drugstartdate>20030801</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
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  <safetyreport>
    <safetyreportid>4531215-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
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    <primarysource>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
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    <safetyreportid>4531216-1</safetyreportid>
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      <qualification>1</qualification>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
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        <reactionmeddrapt>URINARY HESITATION</reactionmeddrapt>
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      <drug>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
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      <qualification>1</qualification>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
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        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LYMPHOMA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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    <safetyreportid>4531218-5</safetyreportid>
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      <qualification>1</qualification>
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    <receiver></receiver>
    <patient>
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      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY HESITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531220-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-618</companynumb>
    <primarysource>
      <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 BETA-D-GLUCAN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531221-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105255</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG95R</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/ 1 DAY</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL W/TRAMADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531222-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105467</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531223-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105470</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>...</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531224-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-619</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>2.5 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG 2X PER 1 WK, SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531226-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105510</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugindication>STRESS SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531227-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105701</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG99M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531228-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-620</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRYPTOCOCCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO SPINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>5 MG 1X PER 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG 1XPER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531230-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105703</companynumb>
    <primarysource>
      <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>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG99M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531231-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105717</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN EXACERBATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531232-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105881</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANASAL SINUS HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG96R</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531233-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW23692</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <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>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOALVEOLAR LAVAGE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EROSIVE DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN T INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETOPTIC</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>VENTOLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531235-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409106099</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00Z</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>40 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531237-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>J081-232-3668</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED BRONCHIAL SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY ASPHYXIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</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>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARNAL (TAMSULOSIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORSENID (SENNOSIDE A+B)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAI-KENCHU-TO (CHINESE HERBAL MEDICINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531239-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBS041116037</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531240-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBS041116044</companynumb>
    <primarysource>
      <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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040210</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531241-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409106100</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG,</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531243-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>Z002-204-0015</companynumb>
    <primarysource>
      <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>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugdosagetext>DOUBLEBLIND, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROID OINTMENT</medicinalproduct>
        <drugdosagetext>TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>TOXIC SKIN ERUPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO (ZONISAMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADOFEED (FLURBIPROFEN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMMETREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN (ZOPICLONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELEGILINE HYDROCHLORIDE (SELEGILINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN (LOXOPROFEN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA (REBAMIPIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOBAL (MECOBALAMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELBINAC (FELBINAC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SHAKUYAKU-KANZO-TO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS ONSHIPPU</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531244-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409106133</companynumb>
    <primarysource>
      <qualification>1</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>
      <reaction>
        <reactionmeddrapt>ORGASMIC SENSATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531245-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZONI002075</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LENTICULAR OPACITIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEGRAN (ZONISAMIDE)</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>100 MG, 2 IN 1 D, ORAL; D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEGRAN (ZONISAMIDE)</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>100 MG, 2 IN 1 D, ORAL; D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETORL (CARBAMAZEPINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531246-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-DEN-08095-01</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</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>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIOPENTAL SODIUM</medicinalproduct>
        <drugdosagetext>500 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVE PILLS (ORAL CONTRACEPTIVE NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NON-PRESCRIPTION PAIN KILLER (NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531247-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409106134</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531248-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-SWI-08092-01</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIANOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPRAM (CITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugdosagetext>75 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLVON (MIANSERIN HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>30 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE DISKUS</medicinalproduct>
        <drugdosagetext>500</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNIFYL (THEOPHYLLINE)</medicinalproduct>
        <drugdosagetext>600 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL (PANTOPRAZOLE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIMAGON-D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA   BOEHRINGER INGELHEIM (TIOTROPIUM BROMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531249-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-GER-08030-01</companynumb>
    <primarysource>
      <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>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRALEX (ESCITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531250-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977189</companynumb>
    <primarysource>
      <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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531252-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE05132</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugdosagetext>8 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugdosagetext>200 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CAROTID ARTERY OCCLUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA NICOTINATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531253-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040903</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977304</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRUXISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG98P</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531255-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05937</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>55 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040708</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>55 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>57 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>57 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>55 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>56 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>55 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>55 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>55 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>55 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>55 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>55 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>55 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>55 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>55 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>55 MG ONCE IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AFIPRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORFINSULFAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOCIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMADRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531256-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977317</companynumb>
    <primarysource>
      <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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SONATA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531258-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040903</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977322</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLUTRIN (BUPROPION HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531259-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004109097</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531260-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977374</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531261-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004109121</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531263-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004109082</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531264-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004109178</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531265-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004109153</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELL-14 (ESTROGENS CONJUGATED, MEDOXYPROGESERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531266-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977380</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531267-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004109028</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531268-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108997</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTRONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531270-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040903</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977385</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>107</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </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>FLINTSTONES MULTIPLE VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531271-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108957</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531272-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040903</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977406</companynumb>
    <primarysource></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>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531273-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040903</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977415</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG99M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531274-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977443</companynumb>
    <primarysource>
      <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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531275-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080160</companynumb>
    <primarysource></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>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>20 MG/ 2 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040828</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531276-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080196</companynumb>
    <primarysource>
      <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>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531277-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080198</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531278-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080201</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531279-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080207</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>120 MG DAY</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531280-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080208</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531281-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080228</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/ 1 DAY</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/ 1 DAY</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/ 1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/ 1 DAY</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/ 1 DAY</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531282-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080235</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531283-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080246</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531284-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080249</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531286-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080262</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00R</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531287-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080270</companynumb>
    <primarysource>
      <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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531288-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080276</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531289-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080306</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531290-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080313</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRUXISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
        <drugindication>DEATH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
        <drugindication>EMOTIONAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531291-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080317</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531292-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080339</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531293-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080345</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531294-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080349</companynumb>
    <primarysource>
      <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>ANORGASMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531295-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080353</companynumb>
    <primarysource>
      <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>ANORGASMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531296-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080354</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG967</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG IN THE EVENING</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG967</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG IN THE EVENING</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOMEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531297-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080357</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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/2 IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531298-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080365</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/ 1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531299-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080372</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/ 1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531300-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080378</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531301-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080390</companynumb>
    <primarysource>
      <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>DYSTONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/ 1 DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531302-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080393</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/2 DAY</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531303-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080401</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531304-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080408</companynumb>
    <primarysource>
      <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>URINARY HESITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/ 1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531305-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080414</companynumb>
    <primarysource>
      <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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531306-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080415</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG96R</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIOTEC (TECHNETIUM TC 99M TEBOROXIME)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531307-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080431</companynumb>
    <primarysource>
      <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>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/ 1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531308-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080433</companynumb>
    <primarysource>
      <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>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/ 1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531309-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080445</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG IN THE MORNING</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAMATINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531310-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080458</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531311-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080479</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/ 1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531312-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080481</companynumb>
    <primarysource>
      <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>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531313-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080482</companynumb>
    <primarysource>
      <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/ 1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531314-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080484</companynumb>
    <primarysource>
      <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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531315-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080487</companynumb>
    <primarysource>
      <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>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONOPIN (CLONAZEPAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531316-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080488</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX - SLOW RELEASE (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/HYDROCODONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531317-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080495</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG43S</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/ 1 DAY</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG43S</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/ 1 DAY</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG43S</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/ 1 DAY</drugdosagetext>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531318-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080503</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/ 1 AT BEDTIME</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC (OMEPRAZOLE RATIOPHARM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531319-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080509</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531320-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080517</companynumb>
    <primarysource>
      <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>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/ 1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531321-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080522</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531322-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080526</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG96R</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG IN THE MORNING</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531323-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080534</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531324-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080540</companynumb>
    <primarysource>
      <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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531325-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978108</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531326-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978119</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTIVE NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531327-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978138</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>20 MG/ 3 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN (GABAPENTIN PFIZER)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531328-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978144</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPULSIVE BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEGATIVE THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG IN THE MORNING</drugdosagetext>
        <drugindication>BIPOLAR II DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE - SLOW RELEASE (VALPROATE SEMISODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531329-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978145</companynumb>
    <primarysource>
      <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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>DYSTHYMIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531330-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978146</companynumb>
    <primarysource>
      <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>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531331-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978152</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY HESITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531332-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978175</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUVOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531333-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978185</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531334-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978189</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531335-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978196</companynumb>
    <primarysource>
      <qualification>5</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SONATA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL PM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR (MONTELUKAST)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531336-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978232</companynumb>
    <primarysource>
      <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>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG96R</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20 MG DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTIVE NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531337-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978236</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531338-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978275</companynumb>
    <primarysource>
      <qualification>2</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20 MG DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040829</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531339-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978276</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SONATA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531340-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978280</companynumb>
    <primarysource>
      <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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531341-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978281</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED THYROID MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531342-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978289</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531343-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978293</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>8RD77T</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>90 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531344-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978302</companynumb>
    <primarysource>
      <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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY HESITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONE REPLACEMENT THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531345-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978308</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SHDDZ</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>RELAXATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELLADONNA EXTRACT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531346-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978314</companynumb>
    <primarysource>
      <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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040908</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531347-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978318</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION POTENTIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531348-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978334</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG98P</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040911</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531349-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978349</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531350-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978353</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>5 DSG FORM</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>5 DSG FORM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531351-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978355</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531352-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978398</companynumb>
    <primarysource>
      <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>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG99M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531353-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978414</companynumb>
    <primarysource>
      <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>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCERTA (METHYLPHENIDATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONOPIN (CLONAZEPAM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531354-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978419</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531355-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US040978429</companynumb>
    <primarysource>
      <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>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531356-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978436</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531357-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978443</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531358-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978464</companynumb>
    <primarysource>
      <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>INTESTINAL HYPERMOTILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531359-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978481</companynumb>
    <primarysource>
      <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>PILOERECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531360-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978482</companynumb>
    <primarysource>
      <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531361-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978483</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531362-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978492</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00Z</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531363-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978511</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG99M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG IN THE MORNING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX (MIRAPEX)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531364-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978519</companynumb>
    <primarysource></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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531365-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410106781</companynumb>
    <primarysource>
      <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>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531366-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410106787</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY HESITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG39P</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC (OMEPRAZOLE RATIOPHARM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE PILL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531367-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410106793</companynumb>
    <primarysource>
      <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>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>20 MG/ 1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531368-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410106797</companynumb>
    <primarysource>
      <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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXICET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531369-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410106885</companynumb>
    <primarysource>
      <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531370-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410106889</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531371-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410106898</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531372-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108215</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531373-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108195</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531374-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108162</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531375-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040977089</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>122</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL WALL NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20559</drugauthorizationnumb>
        <drugdosagetext>2 G</drugdosagetext>
        <drugindication>ABDOMINAL WALL NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20559</drugauthorizationnumb>
        <drugdosagetext>2 G</drugdosagetext>
        <drugindication>ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531376-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184816</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531377-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184727</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR MARKER INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>800 MG</drugdosagetext>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>800 MG</drugdosagetext>
        <drugindication>RECURRENT CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531378-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108879</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531379-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108828</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531380-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041081215</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE DRUG EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugauthorizationnumb>19640</drugauthorizationnumb>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DDAVP (DESMOPRESSIN ACETATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531381-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041080968</companynumb>
    <primarysource>
      <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>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1600 MG</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531382-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041080381</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>134</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531383-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108855</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531384-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108848</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531385-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108854</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531386-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108847</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531387-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004109131</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531388-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184609</companynumb>
    <primarysource>
      <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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531389-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0408105022</companynumb>
    <primarysource>
      <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>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>510 MG</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531390-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0409105870</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>7SC84M</drugbatchnumb>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>42 U/L IN THE MORNING</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>6 U AS NEEDED</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILETIN-BEEF NPH INSULIN (INSULIN, ANIMAL)</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19740101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ILETIN-PORK NPH INSULIN (INSULIN, ANIMAL)</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19740101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531391-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184656</companynumb>
    <primarysource>
      <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>EMBOLIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugindication>STREPTOCOCCAL SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041127</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531392-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184600</companynumb>
    <primarysource>
      <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>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugindication>SEPSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531393-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184646</companynumb>
    <primarysource>
      <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>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XIGRIS</medicinalproduct>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531394-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108654</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>21017</drugauthorizationnumb>
        <drugdosagetext>30 U DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531395-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411107897</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>8RA90M</drugbatchnumb>
        <drugauthorizationnumb>21017</drugauthorizationnumb>
        <drugdosagetext>90 U DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL (TOLTERODINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531396-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040874726</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BURNING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF4D74A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM AND VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531397-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041080999</companynumb>
    <primarysource>
      <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>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531398-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040669252</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS DEFORMANS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF3M22A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531399-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040772182</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC DUCT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF3Z81C</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531400-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041080852</companynumb>
    <primarysource>
      <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>CRYPTOCOCCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOPEPTIDE ANTIBIOTIC RESISTANT ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE 600 PLUS VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531401-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040979143</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>5 MG DAY</drugdosagetext>
        <drugindication>BIPOLAR II DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN (GABAPENTIN PFIZER)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531402-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041081053</companynumb>
    <primarysource>
      <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>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>825 MG</drugdosagetext>
        <drugindication>ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531403-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA031049833</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>25 MG DAY</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCYAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531404-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>202792</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</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>20020917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</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>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531405-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE105709AUG04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>132.11</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>VARIED DOSE - CONCENTRATION CONTROLLED WITH ADMISSION DOSE OF 6 MG DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICITRA (CITRIC ACID/SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLATE SODIUM (FOLATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA (SENNA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C (ASCORBIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS, PLAIN (MULTIVITAMINS, PLAIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC SULFATE (ZINC SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA-D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORCET-HD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531406-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE765806DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugauthorizationnumb>50684</drugauthorizationnumb>
        <drugdosagetext>3.375 G 1X PER 6 HR, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABDOMINAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN W/CLAVULANATE POTASSIUM (AMOXICILLIN/CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>800 MG 2X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010619</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531407-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>203245</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>BRAIN STEM SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P30067</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040506</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531408-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207234</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531409-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210266</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>M25122</drugbatchnumb>
        <drugdosagetext>5 MG/KG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>M21998</drugbatchnumb>
        <drugdosagetext>5 MG/KG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>M15617</drugbatchnumb>
        <drugdosagetext>5 MG/KG, QW2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPTOSAR</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531410-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210000</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>10 MG/KG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA-2B (INTERFERON ALFA-2B)</medicinalproduct>
        <drugdosagetext>9 MIU, 1 /WEEK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531411-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>204544</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.6683</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531412-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KII-2004-0014209</companynumb>
    <primarysource>
      <qualification>3</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 CREATINE PHOSPHOKINASE MB INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>19516</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINE ERIVATIVES()</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531413-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
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      <drug>
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        <drugstartdate>19960101</drugstartdate>
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      <reaction>
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      <reaction>
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      <reaction>
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      <reaction>
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    <patient>
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        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
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      <drug>
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      <drug>
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        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
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    <transmissiondateformat>102</transmissiondateformat>
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      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
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        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK LEFT</reactionmeddrapt>
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      <drug>
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        <drugindication>ATRIAL FIBRILLATION</drugindication>
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      <drug>
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    <transmissiondateformat>102</transmissiondateformat>
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    <patient>
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        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
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        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
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        <medicinalproduct>MILK THISTLE FRUIT CAPSULE</medicinalproduct>
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        <medicinalproduct>VITAMIN E CAPSULES</medicinalproduct>
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        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
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        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
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    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AL001814</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>119.7496</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugauthorizationnumb>74514</drugauthorizationnumb>
        <drugdosagetext>50 MG; BID; PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OVCON-50</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531427-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004058577</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.3273</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEOSPORIN</medicinalproduct>
        <drugdosagetext>ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRY SOCKET</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GELFOAM</medicinalproduct>
        <drugdosagetext>ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRY SOCKET</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (POTASSIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALDECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531428-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101.1521</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>3320 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>170 MG IV Q 2 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESYREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531429-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041201353</companynumb>
    <primarysource>
      <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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
        <drugdosagetext>4000 MG, 1 IN 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTHACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANBESOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531430-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZONI002068</companynumb>
    <primarysource>
      <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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1 IN 1 D, ORAL; 100 MG, 1 IN 1 D, ORAL; 150 MG, 1 IN 1 D, ORAL; 100 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1 IN 1 D, ORAL; 100 MG, 1 IN 1 D, ORAL; 150 MG, 1 IN 1 D, ORAL; 100 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1 IN 1 D, ORAL; 100 MG, 1 IN 1 D, ORAL; 150 MG, 1 IN 1 D, ORAL; 100 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugauthorizationnumb>20789</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1 IN 1 D, ORAL; 100 MG, 1 IN 1 D, ORAL; 150 MG, 1 IN 1 D, ORAL; 100 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531431-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-04854-01</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>121.1104</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLOP RHYTHM PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
        <drugauthorizationnumb>20401</drugauthorizationnumb>
        <drugdosagetext>240 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETHAMETHASONE CREAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIZORAL CREAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531432-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531433-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004091047</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR MARKER INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUDAFED 12 HOUR</medicinalproduct>
        <drugdosagetext>2 TABLETS, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASAL CONGESTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NOS (VITAMINS NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531434-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531435-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>C-04-0065</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOGEN RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN PHOSPHATE</medicinalproduct>
        <drugbatchnumb>26533A</drugbatchnumb>
        <drugauthorizationnumb>63304</drugauthorizationnumb>
        <drugdosagetext>USE AS NEEDED, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DERMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531436-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.2867</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENEKOT-S</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531437-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-07431-01</companynumb>
    <primarysource>
      <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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugauthorizationnumb>21487</drugauthorizationnumb>
        <drugdosagetext>5 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>5 MG, QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACAL (CALCIUM CITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531438-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>640 MG/M2 BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON SULFATETHIAMIN COMPOUND TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531439-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040902</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1002742</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM TREMENS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugbatchnumb>1L4148</drugbatchnumb>
        <drugauthorizationnumb>71591</drugauthorizationnumb>
        <drugdosagetext>2 MG Q 2 HOURS PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALCOHOL DETOXIFICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN SLIDING SCALE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531440-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>21-732-2004-M0001</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL VARICES HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANTAS</medicinalproduct>
        <drugbatchnumb>4F2501</drugbatchnumb>
        <drugauthorizationnumb>21732</drugauthorizationnumb>
        <drugdosagetext>50 MG, ONCE PER YEAR, IMPLANT 057</drugdosagetext>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531441-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040902</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1002743</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM TREMENS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugbatchnumb>1L4148</drugbatchnumb>
        <drugauthorizationnumb>71591</drugauthorizationnumb>
        <drugdosagetext>2 MG Q 2 HOURS PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DETOXIFICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531442-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-06568-01</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.2971</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALCOHOL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKO BILOBA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531443-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040902</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1002744</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugbatchnumb>1L4148</drugbatchnumb>
        <drugauthorizationnumb>71591</drugauthorizationnumb>
        <drugdosagetext>2 MG Q 2 HRS PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DETOXIFICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531444-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>21-732-2004-M0002</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANTAS</medicinalproduct>
        <drugbatchnumb>4F2501</drugbatchnumb>
        <drugauthorizationnumb>21732</drugauthorizationnumb>
        <drugdosagetext>50 MG, ONCE PER YEAR, IMPLANT 057</drugdosagetext>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRO PATCH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531445-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040902</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1002745</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugbatchnumb>1L4148</drugbatchnumb>
        <drugauthorizationnumb>71591</drugauthorizationnumb>
        <drugdosagetext>2 MG Q 2HOURS PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DETOXIFICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531446-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-06119-01</companynumb>
    <primarysource>
      <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>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531447-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004EN000085</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA FUNGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRACHEAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICES OESOPHAGEAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABELCET</medicinalproduct>
        <drugauthorizationnumb>50724</drugauthorizationnumb>
        <drugdosagetext>5 MG/KG;QD;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugindication>FUNGAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASPOFUNGIN</medicinalproduct>
        <drugdosagetext>0.7 MG/KG,QW;IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA FUNGAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN INTRAVENOUS (HUMAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASPOFUNGIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD AND RELATED PRODUCTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531448-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-06697-01</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CITRIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCULUS URETERIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPEROXALURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT INCREASED</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>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>10 MG QOD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>10 MG BIW PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531449-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0002525</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47.1741</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHYOL</medicinalproduct>
        <drugauthorizationnumb>20221</drugauthorizationnumb>
        <drugdosagetext>500 MG, 5 IN 1 WK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RADIOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAALOX (MAGNESIUM HYDROXIDE, ALUMINIUM HYDROXIDE GEL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531450-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-07725-01</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>20 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531451-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0412108744</companynumb>
    <primarysource>
      <qualification>4</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>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531452-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>STA-AE-04-MTX-617</companynumb>
    <primarysource>
      <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>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEXATE</medicinalproduct>
        <drugauthorizationnumb>8085</drugauthorizationnumb>
        <drugdosagetext>17.5 MG 1 WK, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABATACEPT</medicinalproduct>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
      </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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN (MULTIPLE VITAMINS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE ER (NIFEDIPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM + VITAMIN D (CALCIUM + VITAMIN D)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531453-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411107845</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531454-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2004-0017935</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF CRIME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN TABLETS (OXYCODONE HYDROCLORIDE) CR TABLET</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531455-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041081860</companynumb>
    <primarysource>
      <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>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531456-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2004-0017929</companynumb>
    <primarysource></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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITTING OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>SEE TEXT</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL (SIMILAR TO NDA 21-044)(HYDROMORPHONE HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>INTRATHECAL</drugdosagetext>
        <drugadministrationroute>039</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN (OXYGEN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531457-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2004-0017945</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>80 MG, Q12H</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531458-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PERC20040072</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD PH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugauthorizationnumb>40330</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531459-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-032057</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>21098</drugauthorizationnumb>
        <drugdosagetext>1 TAB(S), 1X/DAY, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531460-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA031049961</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANIMAL BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT BELOW NORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROUP INFECTIOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENURESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIDIDYMAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAMILY STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCHLORAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KETONURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPODYSTROPHY ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE STOOLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE FRACTURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEASONAL ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMOGYI PHENOMENON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STARING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STUPOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN L</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>10 U/2 DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN U</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILETIN-BEEF/PORK REGULAR INSULIN (INSULIN, ANIMAL)</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugdosagetext>14 U DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPH ILETIN I (BEEF-PORK)</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRA-LENTE ILETIN INSULIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19681209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILETIN-BEEF/PORK SEMILENTE INSULIN (INSULIN, ANIMAL</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19681209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENTE ILETIN (BEEF-PORK) INSULIN ZINC</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531461-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>430001E04ITA</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYODERMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugdosagetext>11 MG, 1 IN 1 DAYS</drugdosagetext>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATRA, CONTROL FOR GEMTUZUMAB OZOGAMICIN (TRTINOIN)</medicinalproduct>
        <drugdosagetext>80 MG, 1 IN 1 DAYS</drugdosagetext>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTIC AGENTS, CONTROL FOR GEMTUZUMAB OZOGAMICIN (CHEMOTHERA</medicinalproduct>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEICOPLANIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELECTROLYTE SOLUTIONS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANEXAMIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOROLAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HYCLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIP TAZO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTIC AGENTS, CONTROL FOR GEMTUZUMAB</medicinalproduct>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531462-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421173BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>20304</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531463-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>3.5 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531464-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000583</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>56</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>
        <drugbatchnumb>P30086</drugbatchnumb>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531465-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421152BWH</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>20304</drugauthorizationnumb>
        <drugindication>AORTIC SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531466-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000791</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>44</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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531467-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000789</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.6892</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL BYPASS OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND 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>20030130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>4531468-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000794</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.5234</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARTILAGE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>X-RAY ABNORMAL</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>
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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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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAIN MEDICATION NOS</medicinalproduct>
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  <safetyreport>
    <safetyreportid>4531469-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receiptdateformat>102</receiptdateformat>
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      <qualification>2</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <patientweight>151.955</patientweight>
      <patientsex>1</patientsex>
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        <reactionmeddrapt>EAR DISORDER</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1500 MG IV Q 24 HRS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOCARDITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041214</drugstartdate>
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        <drugenddate>20041216</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMYCIN</medicinalproduct>
        <drugdosagetext>220 MG IV Q 24 HRS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAFORAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531470-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000795</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011217</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531471-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000959</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIOPSY LUNG</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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531472-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51.2565</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENDOMETRIAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXEMESTANE</medicinalproduct>
        <drugdosagetext>25 MG PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531473-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>202240</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.7611</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</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>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531474-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108.4097</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL PROBLEM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>20 MG 1/2 PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531475-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000735</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531476-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.1626</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCARDIA XL</medicinalproduct>
        <drugdosagetext>QD</drugdosagetext>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCARDIA XL</medicinalproduct>
        <drugdosagetext>QD</drugdosagetext>
        <drugindication>MALIGNANT HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531477-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000744</companynumb>
    <primarysource></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>
      <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>4531478-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000746</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</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>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P30043</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>4531479-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000747</companynumb>
    <primarysource></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>DROWNING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P30086</drugbatchnumb>
        <drugdosagetext>30 UG;QW;IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531480-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000750</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</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>20031219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531481-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000788</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</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>4531482-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004US001484</companynumb>
    <primarysource>
      <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>FUNGAL ABSCESS CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGICAL PROCEDURE REPEATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>8.00 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL)</medicinalproduct>
        <drugdosagetext>750.00 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>20.00 MG, UID/QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531483-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040156731</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERWEIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT FLUCTUATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>18936</drugauthorizationnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>5 MG/1 AT BEDTIME</drugdosagetext>
        <drugindication>SOMNOLENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC WEEKLY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZADONE (TRAZODONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORLISTAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENTERMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMVIR (PENCICLOVIR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531484-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.1626</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCARDIA XL</medicinalproduct>
        <drugdosagetext>BID</drugdosagetext>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCARDIA XL</medicinalproduct>
        <drugdosagetext>BID</drugdosagetext>
        <drugindication>MALIGNANT HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531485-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-13097BP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUTTOCK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugdosagetext>80 MG (80 MG), NR</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugauthorizationnumb>20850</drugauthorizationnumb>
        <drugdosagetext>80 MG (80 MG), NR</drugdosagetext>
        <drugindication>RENAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO (BLIND)</medicinalproduct>
        <drugdosagetext>80 MG (80 MG) NR</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO (BLIND)</medicinalproduct>
        <drugdosagetext>80 MG (80 MG) NR</drugdosagetext>
        <drugindication>RENAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>1500 MG (250 MG), NR</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MG (10 MG) NR</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531486-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-DE-06018GD</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF WHITE BLOOD CELL COUNT POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEASLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIMPLE PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON GAMMA</medicinalproduct>
        <drugdosagetext>THRICE WEEKLY</drugdosagetext>
        <drugindication>CHRONIC GRANULOMATOUS DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugindication>CHRONIC GRANULOMATOUS DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CMV-IMMUNE GLOBULIN (IMMUNOGLOBULIN CYTOMEGALOVIRUS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531487-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041285135</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>8RT56M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531488-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.6892</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20MG ONE QD</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20MG ONE QD</drugdosagetext>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531489-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.2867</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531490-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184815</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>125</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531491-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04090561</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM 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>20040603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531492-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-0933</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugdosagetext>DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531493-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-0933</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugdosagetext>DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531494-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0411108688</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>40 MG/2 DAY</drugdosagetext>
        <drugindication>URINARY INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC (OMEPRAZOLE RATIOPHARM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN 12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531495-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-0933</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugdosagetext>DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531496-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-0927</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugdosagetext>DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531497-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20041201313</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLANTADIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531498-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041201689</companynumb>
    <primarysource>
      <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>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOPLOGONT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531499-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041202087</companynumb>
    <primarysource>
      <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>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>9TH INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531500-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20041202121</companynumb>
    <primarysource>
      <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>ANAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIANAL ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARCOXIA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531501-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041202576</companynumb>
    <primarysource>
      <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>DELIRIUM</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>4531502-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041202683</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>04F093A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>04F093A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531503-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041202685</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>REITER'S SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531504-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041202690</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531505-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041202692</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531506-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041202693</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.24</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531507-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041202694</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CUTANEOUS LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>04F041P1;04F113A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>04F041P1;04F113A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B12</medicinalproduct>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531508-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041202696</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531509-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041202697</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISCITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531510-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040909152</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.01</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</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>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLENDIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDOMET</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURINETHOL</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531511-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040806757</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.33</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZASAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugdosagetext>OFF FOR TWO YEARS.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531512-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040809421</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47.63</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROSACEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531513-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040809591</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.04</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FACTOR V DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>6MP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531514-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041200326</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIAL CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</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>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIO-THREE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531515-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20041101540</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>27TH INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRYPTLINE</medicinalproduct>
        <drugdosagetext>25-50MG</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B 12</medicinalproduct>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B6</medicinalproduct>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531516-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041105810</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>4RMKA727;4RMKA713</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>4RMKA727;4RMKA713</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531517-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20040808331</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</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>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>APPROXIMATELY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>3 T</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLINORM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAZUREN S</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAZUREN S</medicinalproduct>
        <drugdosagetext>2 GRAMS</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNNORM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMATIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531518-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24944</companynumb>
    <primarysource>
      <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>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugauthorizationnumb>20498</drugauthorizationnumb>
        <drugdosagetext>50 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531519-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040606827</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</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>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLOCORT</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROWASA</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCYAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531520-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040602159</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.93</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLON CANCER</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>CELEBREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531521-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20041106721</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>02L067D</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>02L067D</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5-30 MG PRN</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531522-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041200965</companynumb>
    <primarysource>
      <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>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA LEGIONELLA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERINFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>THE 11TH AND FINAL DOSE WAS ADMINISTERED ON 28-JUL-2004.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PYODERMA GANGRENOSUM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>PYODERMA GANGRENOSUM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERCYTE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>THROMBOCYTOPENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531523-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20030800581</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531524-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041006670</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </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>MERCAPTOPURINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531525-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041006731</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>6-MP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531526-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040700902</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.11</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTMENOPAUSAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531527-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040406435</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.47</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM SICKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAIN PILLS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531528-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040808578</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.38</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DOUBLE STRANDED DNA ANTIBODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTONE ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03L103A;03J073A</drugbatchnumb>
        <drugdosagetext>8 MG/KG X 75 KG = 600 MG IN 250 CC NSS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03L103A;03J073A</drugbatchnumb>
        <drugdosagetext>8 MG/KG X 75 KG = 600 MG IN 250 CC NSS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03L103A;03J073A</drugbatchnumb>
        <drugdosagetext>5 MG/KG X 80 KG = 400 MG IN 250 CC NSS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>03L103A;03J073A</drugbatchnumb>
        <drugdosagetext>8 MG/KG X 75 KG = 600 MG IN 250 CC NSS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>0.5 MG, 2 TABLETS DAILY AT BEDTIME, AS NECESSARY.</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>10 MG PRIOR TO INFLIXIMAB INFUSION.</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>650 MG PRIOR TO INFLIXIMAB INFUSION.</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531529-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041106078</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>AMYOTROPHIC LATERAL SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</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>DISTAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531530-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041106197</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>THIRD DOSE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <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</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531531-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20040905435</companynumb>
    <primarysource>
      <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>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTRIGLYCERIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>LAST TWO INFUSION GIVEN AT A DOSE OF 300MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXEN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAMUDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORENTAL</medicinalproduct>
        <drugdosagetext>400</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERSANTIN INJ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAXILENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTORETIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTORETIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OESCLIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531532-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20040602022</companynumb>
    <primarysource>
      <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>BRAIN ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</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>4531533-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041005205</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFUSE LARGE B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER STAGE IV WITH METASTASES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICES OESOPHAGEAL</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>
        <drugdosagetext>2MG CAPSULE</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>2MG CAPSULE</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>2.5MG TABLET</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCAM</medicinalproduct>
        <drugdosagetext>2 CAPSULES (13.5MG CAPSULES).</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
        <drugdosagetext>2 TABS</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE-S</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE-S</medicinalproduct>
        <drugdosagetext>2 SACHETS OF 500MG EACH.</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOTIN</medicinalproduct>
        <drugdosagetext>3 TABLETS 100MG EACH</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531534-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041106197</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>THIRD DOSE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <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</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531535-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-0933</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugdosagetext>DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531536-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184846</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG43P</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN (DIGOXIN STREULI)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531537-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12790622</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>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531538-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BRISTOL-MYERS SQUIBB COMPANY-12791141</companynumb>
    <primarysource>
      <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>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDIOLITE</medicinalproduct>
        <drugbatchnumb>00423535</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SCAN PARATHYROID</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531539-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12755260</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>168</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESUSCITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEFINITY</medicinalproduct>
        <drugdosagetext>DURATION OF THERAPY: ^MINUTES^</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEFINITY</medicinalproduct>
        <drugdosagetext>DURATION OF THERAPY: ^MINUTES^</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SHOCK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE INJ 10 MG/ML</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>DOSE VALUE:  5000 U/ML VIAL 1 ML. 5000 UNITS TID.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE AND EPINEPHRINE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOREPINEPHRINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN + TAZOBACTAM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531540-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12797171</companynumb>
    <primarysource>
      <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>CALCIPHYLAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART VALVE REPLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531541-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12756318</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELISOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARKA LP</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531542-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12771929</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDIOLITE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531543-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BRISTOL-MYERS SQUIBB COMPANY-12789467</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040905</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDENE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531544-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000877</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531545-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000883</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELLS CSF POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RUPTURED CEREBRAL 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>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531546-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040360713</companynumb>
    <primarysource>
      <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC ISCHAEMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NERVE INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL EXUDATES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOTOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG OTHER</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531547-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410106906</companynumb>
    <primarysource>
      <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>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531548-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04110352</companynumb>
    <primarysource>
      <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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>400 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRAIN NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531549-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410106915</companynumb>
    <primarysource>
      <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>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531550-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12951</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>90 MG, QMO</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040512</drugenddate>
        <drugtreatmentduration>1973</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531551-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410106919</companynumb>
    <primarysource>
      <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531552-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184849</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF4L55A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531553-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184732</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COCCYDYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE FRACTURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF4L55A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARIDIAN (MEPINDOLOL SULFATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531554-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210446</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTROPIN AQ</medicinalproduct>
        <drugauthorizationnumb>20522</drugauthorizationnumb>
        <drugindication>TURNER'S SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531555-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04110412</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
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      <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>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531556-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12791414</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOSPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
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  <safetyreport>
    <safetyreportid>4531557-8</safetyreportid>
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    <transmissiondate>20050328</transmissiondate>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12716981</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
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        <drugindication>PSYCHOTIC DISORDER</drugindication>
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        <drugstartdate>20040916</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>4531558-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
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    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TAP2004Q01551</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
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      <patientweight>35.8342</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT</medicinalproduct>
        <drugauthorizationnumb>20263</drugauthorizationnumb>
        <drugdosagetext>11.25 MG, 1 IN 1 M, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRECOCIOUS PUBERTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531559-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184648</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF4G16C</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531560-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12795456</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>2MG TABLET, 3MG DAILY DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>2MG TABLET, 3MG DAILY DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEBUTOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531561-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12796850</companynumb>
    <primarysource>
      <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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>3-4 TABLETS DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAGID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
        <drugtreatmentduration>198</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531562-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04120175</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531563-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-12790275</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>118</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL POLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040415</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531564-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040421</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200403207</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE REDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROTID ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>READING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX COSMETIC</medicinalproduct>
        <drugindication>MASS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040322</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531565-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0412108804</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugindication>THINKING ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531566-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04120402</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PREGNANCY OF PARTNER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSMISSION OF DRUG VIA SEMEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531567-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410804</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43.0917</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>100 UNITS PRN; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPACON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531568-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184812</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531569-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04110219</companynumb>
    <primarysource></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>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>150 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531570-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184811</companynumb>
    <primarysource></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>CAROTID ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR (SIMVASTATIN RATIOPHARM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531571-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-07773-01</companynumb>
    <primarysource>
      <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>COELIAC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED GASTRIC EMPTYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DYSPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</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>20031201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531572-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0412108765</companynumb>
    <primarysource>
      <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>OROPHARYNGEAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC (OMEPRAZOLE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531573-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-13273RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOPULMONARY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>40054</drugauthorizationnumb>
        <drugdosagetext>600 MG (NR, ONCE), IT</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531574-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419426US</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.4</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugindication>BREAST CANCER FEMALE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESICS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531575-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-13274RO</companynumb>
    <primarysource></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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOPULMONARY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>40054</drugauthorizationnumb>
        <drugdosagetext>600 NR (NR, ONCE), IT</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531576-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KII-2004-0014252</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QRS COMPLEX PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QRS COMPLEX SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE (THEOPHYLLINE)(SIMILAR TO 40-086)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINE DERIVATIVES ()</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUTALBITAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXTROMETHORPHAN HYDROBROMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531577-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-13275RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOPULMONARY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>40054</drugauthorizationnumb>
        <drugdosagetext>196 MG (NR, ONCE), IT</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531578-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>209254</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.2</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD FIBRINOGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATINE PHOSPHOKINASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>5 MG/KG, Q2W; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531579-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040913</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BR12042</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugdosagetext>4.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugdosagetext>10.5 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>UNK, TID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUCIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURAN T4</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531580-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004NL17327</companynumb>
    <primarysource>
      <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>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040710</drugenddate>
        <drugtreatmentduration>95</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531581-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-13276RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOPULMONARY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>40054</drugauthorizationnumb>
        <drugdosagetext>600 MG (NR, ONCE), IT</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531582-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-13277RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>40054</drugauthorizationnumb>
        <drugdosagetext>364 MG (NR, ONCE); IT</drugdosagetext>
        <drugadministrationroute>038</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531583-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>10066955-UNKNOWN-0</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFAZOLIN</medicinalproduct>
        <drugauthorizationnumb>63002</drugauthorizationnumb>
        <drugdosagetext>EPIDURAL</drugdosagetext>
        <drugadministrationroute>008</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531584-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-13278RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOPULMONARY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>40054</drugauthorizationnumb>
        <drugdosagetext>300 MG (, ONCE), IT</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531585-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-13279RO</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>40054</drugauthorizationnumb>
        <drugdosagetext>155 MG (, ONCE), IT</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531586-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19980610</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F/98/01334/LES</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CARBON MONOXIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRACKLES LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYPTOGENIC ORGANIZING PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CONSOLIDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRINITRIN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCHOL</medicinalproduct>
        <drugdosagetext>60 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980726</drugenddate>
        <drugtreatmentduration>418</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531587-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12791463</companynumb>
    <primarysource>
      <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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEPESID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531588-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DL20041197</companynumb>
    <primarysource>
      <qualification>3</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION INFECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RUPTURED ECTOPIC PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIFEPRISTONE TABLETS, 200 MG (DANCO LABS)</medicinalproduct>
        <drugbatchnumb>03003</drugbatchnumb>
        <drugauthorizationnumb>20687</drugauthorizationnumb>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugdosagetext>800 MCG , VAGINAL</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531589-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE03990</companynumb>
    <primarysource>
      <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>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>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCOL</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531590-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04100840</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.8023</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMOSOME ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXERCISE TOLERANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040711</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RBC TRANSFUSIONS (BLOOD TRANSFUSION, AUXILIARY PRODUCTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISORDIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYBAN SR (BUPROPION HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE ER (GLIPIZIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT (ERYTHROPOIETIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELET TRANSFUSIONS (BLOOD TRANSFUSION, AUXILIARY PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531591-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BR16568</companynumb>
    <primarysource>
      <qualification>5</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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABYRINTHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
        <drugbatchnumb>U0093</drugbatchnumb>
        <drugdosagetext>1 DF, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ELECTROLYTE SUBSTITUTION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLCADIL</medicinalproduct>
        <drugdosagetext>1 TAB/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HCL W/HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531592-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CA16906</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531593-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-05075</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYTROL</medicinalproduct>
        <drugbatchnumb>9180952</drugbatchnumb>
        <drugauthorizationnumb>21351</drugauthorizationnumb>
        <drugdosagetext>1 PATCH, 2/WEEK, TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531594-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106465</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROPIPATE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531595-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004NO15121</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>40 UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBYL</medicinalproduct>
        <drugdosagetext>75 UNK, UNK</drugdosagetext>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>LEVEL 1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531596-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106566</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531597-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108867</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531598-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000122</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINOPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST COSMETIC SURGERY</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>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>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531599-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000572</companynumb>
    <primarysource></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>DIAPHRAGMATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</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>20041126</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531600-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A0357835A2002001900-1</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE CYSTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGORAPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>20031</drugauthorizationnumb>
        <drugdosagetext>SEE DOSAGE TEXT / ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D.PROPOXY-N + PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN TRIHYDRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOX.TRIHYD+POT.CLAVULAN.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAVOXATE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTYRAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICYCLOMINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESGIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORDETTE-21</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIZATIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSYLLIUM HUSK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINE POLACRILEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DROPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PETHIDINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531601-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A03200404057</companynumb>
    <primarysource>
      <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>PORTAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>NI; INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531602-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>20037197-C62781-000</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.05</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUTTOCK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugbatchnumb>C627281</drugbatchnumb>
        <drugauthorizationnumb>16677</drugauthorizationnumb>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLASMAPHERESIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531603-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.0396</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SELEGINE  5MG  APOTEX</medicinalproduct>
        <drugbatchnumb>GN6629</drugbatchnumb>
        <drugdosagetext>5 MG  TWICE DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE-M/APAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROPAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531604-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104096</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugauthorizationnumb>5845</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHROPOD STING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19490101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531605-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105849</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>8762</drugauthorizationnumb>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531606-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-UK102170</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</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>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYTELASE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LERCANIDIPINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTROPAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBENONIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORDIE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531607-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>GP5671</drugbatchnumb>
        <drugdosagetext>20MG 1 PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531608-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-UK102007</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARA-C</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531609-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugbatchnumb>4039604</drugbatchnumb>
        <drugdosagetext>PRN ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531610-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>GP0108</drugbatchnumb>
        <drugdosagetext>2 CAPS PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531611-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104723</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLORECTAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>8762</drugauthorizationnumb>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20 MG (20 MG, 1  IN 1 D)</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTINEOPLASTIC AGENTS (ANTINEOPLASTIC AGENTS)</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON (IRON)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM (MINERALS NOS, VITAMINS NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531612-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100529</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.2554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART VALVE REPLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugbatchnumb>39R016F</drugbatchnumb>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 AS NECESSARY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN (WARFARIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS (ASCORBIC ACID/ERGOCALCIFEROL/FOLIC ACID/NICOTINAMIDE/PA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES (ANTIHYPERTENSIVES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531613-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531614-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG QD  PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531615-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>GP0103</drugbatchnumb>
        <drugdosagetext>20MG PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>GP0103</drugbatchnumb>
        <drugdosagetext>20MG PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531616-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>GP5665</drugbatchnumb>
        <drugdosagetext>20MG PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531617-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004109556</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN SODIUM</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531618-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184645</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEG AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>7SE49U</drugbatchnumb>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>40 U DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531619-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200422075GDDC</companynumb>
    <primarysource>
      <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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOROQUINE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531620-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200422067GDDC</companynumb>
    <primarysource>
      <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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLLAPSE OF LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531621-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419484US</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLONIC OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531622-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200422072GDDC</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531623-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031030</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200311282JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>152</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMATIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORCAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALFINA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTACID THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugdosagetext>DOSE: 5MG/WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMACART-N</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMACART-N</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531624-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040602</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200411895JP</companynumb>
    <primarysource>
      <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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE STOOLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALAZOPYRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KELNAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIVADIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEROMIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON DEFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>DOSE: 6MG/WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020107</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531625-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040805</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415956US</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPIRATORY RESERVE VOLUME DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FUNCTION TEST DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>COAGULOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531626-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184777</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>75E470</drugbatchnumb>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>43 U DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19740101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531627-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOP TRESADERM</medicinalproduct>
        <drugdosagetext>OPHT</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>MEDICATION ERROR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531628-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184681</companynumb>
    <primarysource></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>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531629-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030310</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200312251US</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46.8</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BETA HAEMOLYTIC STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS MICROSCOPIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugbatchnumb>UNK</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>FOSAMAX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEREX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS, PLAIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOLD</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE: UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531630-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200412554DE</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUTAMATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS TOXIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040723</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531631-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040811</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200412536EU</companynumb>
    <primarysource>
      <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>MONOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFRACTORY ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEDERTREXATE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIROMED DISPERS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIUMACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531632-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A03200403196</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.3388</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>65 MG/M2 Q2W - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531633-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>133.8111</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPULSIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugdosagetext>60 MG TWICE DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531634-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.3273</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030520</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531635-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>1500 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531636-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>30.6</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANTIBODY TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN G INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IIIRD NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SIMPLE PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugdosagetext>100 MG/M2/DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM RECURRENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugdosagetext>100 MG/M2/DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
        <drugdosagetext>30 MG/M2/DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFIXIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IL-12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531637-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AURICULAR SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugindication>INTERVERTEBRAL DISC PROTRUSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugindication>SPINAL DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531638-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMMUNICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugdosagetext>30 MG DAILY, BEDTIME ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531639-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES INSIPIDUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPITUITARISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG TWICE WEKLY SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DDAVP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531640-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>500 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RID MOUSSE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531641-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106.5953</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>40 MG PO Q DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531642-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106.5953</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40 MG PO Q DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531643-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13358</companynumb>
    <primarysource>
      <qualification>3</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>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041203</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531644-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040302</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB01275</companynumb>
    <primarysource>
      <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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>400MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE</medicinalproduct>
        <drugdosagetext>300MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>200MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>275MG/DAY</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>100MG MANE/200MG NOCTE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>400MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040323</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531645-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.8946</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>1.3 MG/M2 IV DAYS 1,4,8,11</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>1.3 MG/M2 IV DAYS 1,4,8,11</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM RECURRENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>1.3 MG/M2 IV DAYS 1,4,8,11</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>1.3 MG/M2 IV DAYS 1,4,8,11</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM RECURRENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>1.3 MG/M2 IV DAYS 1,4,8,11</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>1.3 MG/M2 IV DAYS 1,4,8,11</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM RECURRENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM W/ VIT D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531646-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>159.2126</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRIAPISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>300 MG QID, 200 MG QHS</drugdosagetext>
        <drugindication>MENTAL RETARDATION SEVERITY UNSPECIFIED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531647-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531648-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413245JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>34.8</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON BINDING CAPACITY TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOSPOR</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUER</medicinalproduct>
        <drugdosagetext>DOSE: 2CAPSULES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEANAL</medicinalproduct>
        <drugdosagetext>DOSE: 4TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOLONG</medicinalproduct>
        <drugdosagetext>DOSE: 2TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
        <drugdosagetext>DOSE: 1CAPSULE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALESION</medicinalproduct>
        <drugdosagetext>DOSE: 1TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINCOCIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSMICIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531649-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413819JP</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMYOTROPHIC LATERAL SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RILUTEK</medicinalproduct>
        <drugindication>AMYOTROPHIC LATERAL SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTHPHYLLIN</medicinalproduct>
        <drugdosagetext>DOSE: 3 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANALDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITOROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANSPORIN T</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAINTATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531650-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414607FR</companynumb>
    <primarysource></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>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMUREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531651-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200422192GDDC</companynumb>
    <primarysource></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>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLODIL</medicinalproduct>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KREDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORVASAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRIDERM TTS</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531652-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200422195GDDC</companynumb>
    <primarysource>
      <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>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531653-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200412807DE</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODE UNBROKEN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANDESARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531654-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414721FR</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SPLENIC RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531655-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413328JP</companynumb>
    <primarysource>
      <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>AMYOTROPHIC LATERAL SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RILUTEK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMYOTROPHIC LATERAL SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040616</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531656-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040311</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410963JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIPEN (INSULIN PUMP)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MOVEMENT DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAMA</medicinalproduct>
        <drugdosagetext>DOSE: AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MOVEMENT DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040402</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531657-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413606JP</companynumb>
    <primarysource>
      <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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOKUNALIN</medicinalproduct>
        <drugadministrationroute>003</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYONAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>DOSE: 2-3 TIMES A DAY</drugdosagetext>
        <drugadministrationroute>003</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugadministrationroute>003</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN SUPPOSITORIEN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
      </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>LIPOVAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HACHIMIJIO-GAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARNAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UBRETID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SHAKUYAKUKANZOUTOU</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531658-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413257JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </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>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST NEGATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RENAL FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENIVACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMELIAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D ALFA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE-A</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE-A</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531659-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-04P-087-0279578-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIOPENTAL SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE</medicinalproduct>
        <drugdosagetext>60%</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRYSTALLOID SOLUTION</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLASMANATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAP</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLASMA PROTEIN FRACTION (HUMAN)</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE SULFATE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA REVERSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE HCL</medicinalproduct>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>EPIDURAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>EPIDURAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPIVACAINE</medicinalproduct>
        <drugadministrationroute>008</drugadministrationroute>
        <drugindication>EPIDURAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPIVACAINE</medicinalproduct>
        <drugadministrationroute>008</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPHEDRINE HCL 1PC SOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANALGESIC EFFECT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOSTIGMINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAESTHESIA REVERSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531660-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040917</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0273824-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXERCISE TOLERANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAMILY STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FULL BLOOD COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER DUE TO A GENERAL MEDICAL CONDITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOANING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDODEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC INDUCED ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR INTERNAL DIAMETER ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020317</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>500MG AM AND 750MG PM</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020317</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1000MG AM AND 750MG PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>750MG AM, 500MG NOON, 1000MG PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1000MG AM, 750MG NOON, 1000MG PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1000MG AM, 750 MG NOON</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>750MG AM AND 1000MG PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19710101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM</medicinalproduct>
        <drugdosagetext>100MG AM AND 200MG PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020317</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19710101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
        <drugdosagetext>500MG AM AND 375MG PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
        <drugdosagetext>250MG AM AND 375MG PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENEX LA TABLETS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020317</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTEX CAP</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000720</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>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINSEED OIL</medicinalproduct>
        <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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531661-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184821</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531662-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041284919</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531663-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA030434112</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJACULATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>80 MG DAY</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531664-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041284910</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>40 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531665-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184779</companynumb>
    <primarysource>
      <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>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531666-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102757</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91.6266</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIPLE VESSEL BYPASS GRAFT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, PRN), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EXOSTOSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE (GLUCOSAMINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531667-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>211007</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIVASE</medicinalproduct>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531668-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210484</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOALVEOLAR LAVAGE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYPTOGENIC ORGANIZING PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>1/WEEK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531669-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103631</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>4 MG (4 MG, EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB (CELECOXIB)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531670-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>211054</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>500 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA-2B (INTERFERON ALFA-2B)</medicinalproduct>
        <drugdosagetext>9 MU, 3/WEEK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531671-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103863</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROGAINE</medicinalproduct>
        <drugauthorizationnumb>20834</drugauthorizationnumb>
        <drugdosagetext>1 ML BID, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531672-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ROSACEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSULA GEL</medicinalproduct>
        <drugdosagetext>APPLY TO FACE QD</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ROSACEA</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORITATE</medicinalproduct>
        <drugdosagetext>APPLY TO FACE QD</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ROSACEA</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLEXIAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531673-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531674-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>136.0791</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>HEART VALVE REPLACEMENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531675-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.4827</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugdosagetext>PO TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531676-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.3753</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugdosagetext>400 MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531677-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103646</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TENDONITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARISOPRODOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531678-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>2.5 MG PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531679-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103814</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 2 IN 1 WK), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (VITAMINS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531680-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104058</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.3795</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531681-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004092420</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROGAINE</medicinalproduct>
        <drugbatchnumb>55FSP</drugbatchnumb>
        <drugauthorizationnumb>19501</drugauthorizationnumb>
        <drugdosagetext>AMT BID, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALISILIC ACID (ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531682-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108844</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531683-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODICLEAR DH</medicinalproduct>
        <drugdosagetext>1 - 2 TSP QID PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODICLEAR DH</medicinalproduct>
        <drugdosagetext>1 - 2 TSP QID PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531684-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OMPQ-PR-0412S-1405</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48.5349</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARM AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTREMITY NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FINGER AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BURNING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR PERIPHERAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIAL PULSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugauthorizationnumb>18956</drugauthorizationnumb>
        <drugdosagetext>70 ML, SINGLE DOSE</drugdosagetext>
        <drugindication>BRAIN MASS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugauthorizationnumb>18956</drugauthorizationnumb>
        <drugdosagetext>70 ML, SINGLE DOSE</drugdosagetext>
        <drugindication>MENTAL STATUS CHANGES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>12 MG, SINGLE DOSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531685-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.1428</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugdosagetext>10MG PO BID</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>CAROTID ARTERY ANEURYSM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531686-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108802</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531687-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US014352</companynumb>
    <primarysource>
      <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>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SHOCK SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugauthorizationnumb>20717</drugauthorizationnumb>
        <drugindication>FATIGUE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugauthorizationnumb>20717</drugauthorizationnumb>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531688-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-04P-087-0282723-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>12</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VECURONIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLPRINONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531689-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>430090K04USA</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531690-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106721</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531691-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184714</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531692-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105218</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM (LITHIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531693-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>235967K04USA</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE BITING</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>20030912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531694-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978937</companynumb>
    <primarysource>
      <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>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531695-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20041104328</companynumb>
    <primarysource>
      <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>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPULSID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DIABETIC GASTROPARESIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESIC</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531696-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000737</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <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>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>20040501</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>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531697-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978954</companynumb>
    <primarysource></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>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>120 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>120 MG DAY</drugdosagetext>
        <drugindication>DRUG RESISTANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONE REPLACEMENT THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN (GABAPENTIN PFIZER)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531698-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CEL-2004-02092-ROC</companynumb>
    <primarysource>
      <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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPENTUM</medicinalproduct>
        <drugauthorizationnumb>19715</drugauthorizationnumb>
        <drugdosagetext>750MG THREE TIMES DAILY, ROUTE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531699-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978970</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00Z</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531700-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040465841</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT RANGE OF MOTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF3X85A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531701-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978979</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG AT BEDTIME</drugdosagetext>
        <drugindication>NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531702-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040566451</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>39</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF3X85A</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040403</drugstartdate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531703-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184799</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531704-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978990</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>40 MG IN THE MORNING</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXATIVE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOTOX (BOTULINUM TOXIN TYPE A)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531705-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004107907</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531706-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106709</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531707-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978994</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG98S</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVE PILL (ORAL CONTRACEPTIVE NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531708-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106681</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531709-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004107916</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTORGENS CONJUGATED (ESTROGENS CONJUGATED)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531710-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978996</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531711-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004107910</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531712-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979002</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531713-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979006</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00Z</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORINAL W/CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN (CLORAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531714-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004069516</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94.8018</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>200 MG 3 IN 1 D</drugdosagetext>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>200 MG 3 IN 1 D</drugdosagetext>
        <drugindication>AGGRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OBETROL (AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCH</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531715-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979020</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531716-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004082272</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50.8029</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>50784</drugauthorizationnumb>
        <drugdosagetext>500 MG (500 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE VITAMINS (ASCORBIC ACID, ERGOCALCIFEROL, FOLIC ACID, RETINOL,</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531717-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979028</companynumb>
    <primarysource>
      <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00Z</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531718-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184824</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>8RL98M</drugbatchnumb>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>63 U DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531719-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979049</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY HESITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531720-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_25462_2004</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.9363</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER OTICUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONTROL OF LEGS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugauthorizationnumb>18602</drugauthorizationnumb>
        <drugdosagetext>60 MG TID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOSPASM CORONARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19700101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDIZEM CD</medicinalproduct>
        <drugdosagetext>240 MG Q DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531721-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979050</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EJACULATION FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG39P</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRESSTABS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZADONE (TRAZODONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBERCON (POLYCARBOPHIL CALCIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531722-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979052</companynumb>
    <primarysource>
      <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>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531723-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041081479</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEG AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>7SE14P</drugbatchnumb>
        <drugauthorizationnumb>21017</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531724-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979054</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531725-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979058</companynumb>
    <primarysource>
      <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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531726-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979081</companynumb>
    <primarysource>
      <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL (ALMOTRIGINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531727-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979083</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531728-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979088</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANORGASMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG98P</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531729-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979111</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00Z</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531730-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979129</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531731-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US014415</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugauthorizationnumb>20747</drugauthorizationnumb>
        <drugdosagetext>800 UG BUCCAL</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531732-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>235643K04USA</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH SCALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT 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>20040503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROSEQUELS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN (MULTIVITAMINS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531733-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030404</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ROCHE-335345</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANTED KIDNEY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETHRAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030331</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030415</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531734-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-368525</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040303</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugdosagetext>DOSE WAS REDUCED DUE TO ADVERSE EVENT.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040410</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040317</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugdosagetext>DOSE WAS REDUCED DUE TO ADVERSE EVENT.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040421</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE</medicinalproduct>
        <drugdosagetext>STARTED BEFORE PEG INTERFERON ALFA 2A THERAPY. DRUG NAME WAS REPORTED AS: SODIUM 1.4-DIMETHYL-17-SO+</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>STARTED BEFORE PEG INTERFERON ALFA 2A THERAPY. REASON FOR USE: TO TREAT COMPLICATIONS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>STARTED BEFORE PEG INTERFERON ALFA 2A THERAPY. REASON FOR USE: TO TREAT COMPLICATIONS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>STARTED BEFORE PEG INTERFERON ALFA 2A THERAPY. REASON FOR USE: TO TREAT COMPLICATIONS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugdosagetext>STARTED BEFORE PEG INTERFERON ALFA 2A THERAPY. REASON FOR USE: TO TREAT COMPLICATIONS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>STARTED BEFORE PEG INTERFERON ALFA 2A THERAPY. DRUG REPORTER TO BE: LIPITOR ATORVASTATIN (CALCIUM H+</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>REASON FOR USE: TO PREVENT ADR.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531735-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20010423</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-259323</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALBUMIN CSF ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOALVEOLAR LAVAGE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUILLAIN-BARRE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPHILUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCAPNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010327</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010322</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-TRIMOXAZOLE</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOTREX</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531736-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030409</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-335630</companynumb>
    <primarysource>
      <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>AREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>INCREMENTAL UNTIL  A TOTAL OF 100 MG WAS GIVEN.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531737-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030821</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ROCHE-345137</companynumb>
    <primarysource>
      <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>OESOPHAGEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA-2A</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030716</drugenddate>
        <drugtreatmentduration>337</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030716</drugenddate>
        <drugtreatmentduration>337</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531738-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030521</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-338538</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL CENTRAL NERVOUS SYSTEM ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL DISABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531739-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979142</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531740-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040810</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-377522</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>ROUTE REPORTED AS INJECTION.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040918</drugenddate>
        <drugtreatmentduration>141</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>REPORTED AS DOSE REDUCTION.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugdosagetext>DOSAGE REGIMEN: 3 PILLS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040918</drugenddate>
        <drugtreatmentduration>141</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>DOSAGE REGIMEN: 1 PILL, 1/DAY, 300 MG STRENGTH FOR SEIZURE LIKE ACTIVITY. THEN INCREASED ON 01 MAY +</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>DOSAGE REGIMEN: 1 PILL TWO TIMES/DAY. PATIENT HAS TAKEN 150 MG STRENGTH AND 3.5MG STRENGTH ALSO.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugdosagetext>DOSAGE REGIMEN: 2 PILLS 2 TIMES/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOCET</medicinalproduct>
        <drugdosagetext>STRENGTH: 5/325. DOSAGE REGIMEN: 1 PILL EVERY 4 TO 6 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>DOSAGE REGIMEN: 1 PILL 2 TIMES PER DAY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531741-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040804</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-376777</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS ANI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PAPILLOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531742-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979145</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531743-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-383029</companynumb>
    <primarysource>
      <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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
        <drugtreatmentduration>120</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
        <drugtreatmentduration>120</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
        <drugtreatmentduration>135</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1MG IRREGULARLY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALGIN</medicinalproduct>
        <drugdosagetext>20 AS NEEDED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAUMAL</medicinalproduct>
        <drugdosagetext>20 AS NEEDED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531744-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979146</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugbatchnumb>BM7400372</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>5 MG/1 IN THE EVENING</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COCAINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531745-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-374284</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALPHA 1 FOETOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOBULINS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL HAEMOGLOBIN CONCENTRATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SARCOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICES OESOPHAGEAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040429</drugenddate>
        <drugtreatmentduration>133</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040429</drugenddate>
        <drugtreatmentduration>133</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531746-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-385402</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROXINE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531747-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-ROCHE-380874</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGRAPHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANIGAST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENCORTON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLO (DICLOFENAC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESSENTIALE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROFENID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugdosagetext>UNKNOWN DIABETIC MEDICATION</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040315</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531748-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979149</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>20 MG DAY</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN (GABAPENTIN PFIZER)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531749-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-385819</companynumb>
    <primarysource>
      <qualification>2</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 CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTHRACYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>H.S.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>H.S.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>P.R.N.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURAZEPAM</medicinalproduct>
        <drugdosagetext>H.S.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>H.S.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531750-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-388621</companynumb>
    <primarysource>
      <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>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531751-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040920</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-ROCHE-381052</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACQUIRED DYSFIBRINOGENAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040904</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXABEPILONE</medicinalproduct>
        <drugdosagetext>ONE PER ONE CYCLE.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531752-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979174</companynumb>
    <primarysource>
      <qualification>3</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531753-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-381484</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HYGROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLAVICLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC AUTONOMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FINGER AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY GLAND MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
        <drugtreatmentduration>106</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
        <drugtreatmentduration>92</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
        <drugdosagetext>34 UNITS TAKEN A.M. AND 20 UNITS P.M.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugdosagetext>SLIDING SCALE DOSE REPORTED.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARIJUANA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCERNA</medicinalproduct>
        <drugdosagetext>2 CANS TAKEN DAILY. FORMULATION: LIQUID.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>THE PATIENT STOPPED TAKING THIS MEDICATION, ONE WEEK AGO.</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19790615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLORINEF</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531754-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-382755</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS NEUROSENSORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>REPORTED AS 4/DAY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531755-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-385393</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531756-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-383407</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040219</drugenddate>
        <drugtreatmentduration>332</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031225</drugenddate>
        <drugtreatmentduration>276</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040415</drugenddate>
        <drugtreatmentduration>112</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040122</drugenddate>
        <drugtreatmentduration>304</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030407</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030407</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030407</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030407</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030407</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030407</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531757-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979182</companynumb>
    <primarysource>
      <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>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531758-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-385280</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUILLAIN-BARRE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531759-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ROCHE-386778</companynumb>
    <primarysource>
      <qualification>1</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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREXAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRINETTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
        <drugtreatmentduration>302</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531760-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-388456</companynumb>
    <primarysource>
      <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>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERCINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOPHEDRIN</medicinalproduct>
        <drugindication>COUGH</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531761-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-386609</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040822</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>TAKEN DAILY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040822</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040819</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040919</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531762-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979208</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531763-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-389249</companynumb>
    <primarysource>
      <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>MITOCHONDRIAL MYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYASTHENIA GRAVIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531764-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SP000302</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM POOR R-WAVE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugbatchnumb>S4C143</drugbatchnumb>
        <drugauthorizationnumb>20837</drugauthorizationnumb>
        <drugdosagetext>0.63 MG/3 ML; INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531765-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-388625</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040107</drugenddate>
        <drugtreatmentduration>337</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>DOSAGE REGIMEN: 5/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040115</drugenddate>
        <drugtreatmentduration>345</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531766-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-389086</companynumb>
    <primarysource>
      <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 MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040415</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531767-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-389081</companynumb>
    <primarysource>
      <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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL EXUDATES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA NOS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040311</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531768-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040924</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979209</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531769-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-389239</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041128</drugenddate>
        <drugtreatmentduration>136</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531770-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-388925</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HORIZON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531771-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>235899K04USA</companynumb>
    <primarysource></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>REBIF</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531772-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-ROCHE-388657</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENARENAL</medicinalproduct>
        <drugdosagetext>REGIMEN REPORTED AS 1 TIMES 1.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETONAL FORTE</medicinalproduct>
        <drugdosagetext>REGIMEN REPORTED AS 2 TIMES 1.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTAZOLAM</medicinalproduct>
        <drugdosagetext>REGIMEN REPORTED AS 1 TIMES 1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040107</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531773-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-388817</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL VARICES HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040621</drugenddate>
        <drugtreatmentduration>337</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA-2A</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030303</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA-2A</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030721</drugenddate>
        <drugtreatmentduration>141</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040621</drugenddate>
        <drugtreatmentduration>505</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531774-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979214</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531775-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-389208</companynumb>
    <primarysource>
      <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>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETRUSITOL</medicinalproduct>
        <drugdosagetext>TAKEN UNTIL THE 7TH WEEK OF PREGNANCY.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
        <drugdosagetext>TAKEN EVERY DAY.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531776-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041201676</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOCET</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARDYFERON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADANCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODOPAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODOPAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLO 3</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLO 3</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLO 3</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANAKAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSILANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSILANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030209</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531777-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040924</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979219</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY HESITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>20 MG/2 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICYCLOMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531778-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041202814</companynumb>
    <primarysource>
      <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICAFUNGIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULENE SULFONATE SODIUM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOCISTEINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROMETHORPHAN HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531779-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-JNJFOC-20041203302</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
        <drugdosagetext>FOR SEVEN DAYS EVERY FOURTH WEEK, REPEATED THREE TIMES.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531780-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041202304</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531781-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-JNJFOC-20041202859</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMAL RETARD</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOXAZOLAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531782-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041106511</companynumb>
    <primarysource>
      <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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030529</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAHISTINE MESILATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030530</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMEBUTINE MALEATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCREATIC ENZYME COMBINED DRUG</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030531</drugenddate>
        <drugtreatmentduration>205</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOPENAC SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030531</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030531</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030531</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030531</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531783-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041204481</companynumb>
    <primarysource>
      <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>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZALDIAR</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STABLON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531784-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040924</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979225</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531785-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979230</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>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531786-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040924</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979233</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531787-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979250</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROGRADE EJACULATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531788-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040924</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979261</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531789-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979331</companynumb>
    <primarysource>
      <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>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG98S</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531790-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA00112B1</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN STEM SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS NEUROSENSORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULTRASOUND SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDOMET</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDOMET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531791-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040924</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979338</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531792-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA00112M</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROTID GLAND ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDOMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDOMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531793-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0412USA02001</companynumb>
    <primarysource>
      <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>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVACT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531794-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00857</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYTRAUMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531795-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979359</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/2 DAY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531796-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979365</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531797-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0356</companynumb>
    <primarysource>
      <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>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531798-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040824</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0408GBR00226</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88</patientweight>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOMANIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531799-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041117</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA03466</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OSTEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VOGT-KOYANAGI-HARADA SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VOGT-KOYANAGI-HARADA SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531800-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03146</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>123</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANTICOAGULANT THERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASMA VISCOSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531801-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030806</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0308USA00752</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATELLOFEMORAL PAIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JOINT INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020108</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020108</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>JOINT INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010808</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531802-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00640</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADRENAL ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADRENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR PERIPHERAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN-D</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROPATCH</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPULSID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531803-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA01566</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020315</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020719</drugenddate>
        <drugtreatmentduration>1222</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTACID THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020315</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARNAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020719</drugenddate>
        <drugtreatmentduration>1222</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531804-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA04069</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531805-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0307USA03456</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL NEEDLE STICK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADNEXA UTERI MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTNASAL DRIP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531806-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031222</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0312USA02301</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010210</drugenddate>
        <drugtreatmentduration>328</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPERIDINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010210</drugenddate>
        <drugtreatmentduration>406</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531807-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0404USA00918</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEREAVEMENT REACTION</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>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BURSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000827</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EXOSTOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000827</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531808-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041008</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA01449</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK LEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531809-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0401USA01716</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>109</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC FATIGUE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
        <drugtreatmentduration>416</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
        <drugtreatmentduration>416</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIMICROBIAL (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531810-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979366</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531811-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979371</companynumb>
    <primarysource>
      <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>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040919</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALMANE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531812-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040924</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979372</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 5</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531813-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00604</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKGO BILOBA EXTRACT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE AND CHOLECALCIFEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531814-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-MERCK-0412ITA00020</companynumb>
    <primarysource>
      <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>ALLERGIC GRANULOMATOUS ANGIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS MINIMAL LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPAFENONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040522</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040522</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531815-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00087</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPIPRAMOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040327</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531816-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040924</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979378</companynumb>
    <primarysource>
      <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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY/A FEW DAYS</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531817-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00384</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMPUTATION REVISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERMITTENT CLAUDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEG AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991225</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531818-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030910</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0309USA01174</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICOBRACHIAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</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>DYSTHYMIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAVITATIONAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011015</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011015</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESIC OR ANESTHETIC (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531819-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0412108745</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE FRACTURES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugauthorizationnumb>20815</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531820-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979388</companynumb>
    <primarysource>
      <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>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531821-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184737</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531822-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979395</companynumb>
    <primarysource>
      <qualification>1</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>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531823-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA02021</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531824-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00631</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COSTOCHONDRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOLERANCE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAINFUL RESPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOBACCO ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULCERIN (CIMETIDINE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULCERIN (CIMETIDINE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGYRAX (MECLIZINE HYDROCHLORIDE)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGYRAX (MECLIZINE HYDROCHLORIDE)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOPHYLLINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531825-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979399</companynumb>
    <primarysource>
      <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>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531826-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979405</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531827-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979410</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>109</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531828-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041285042</companynumb>
    <primarysource></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>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 50/50</medicinalproduct>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531829-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979419</companynumb>
    <primarysource>
      <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>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>78G97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531830-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03988</companynumb>
    <primarysource>
      <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>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARATHYROID TUMOUR BENIGN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531831-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA02019</companynumb>
    <primarysource>
      <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>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531832-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00710</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASILAR ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531833-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00606</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531834-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004053543</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALDECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531835-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03146</companynumb>
    <primarysource>
      <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>ARTERIAL BYPASS OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLANTAR FASCIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020423</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</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>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010309</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531836-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0412AUS00089</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531837-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104412</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSPRA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531838-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040401</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0404USA00096</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERONEAL NERVE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURITIC PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020630</drugenddate>
        <drugtreatmentduration>1127</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020630</drugenddate>
        <drugtreatmentduration>1127</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020630</drugenddate>
        <drugtreatmentduration>1127</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020630</drugenddate>
        <drugtreatmentduration>1127</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531839-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004088763</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ECONOMIC PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531840-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01000</companynumb>
    <primarysource>
      <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>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531841-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0412FRA00051</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSEUDO LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531842-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01547</companynumb>
    <primarysource>
      <qualification>5</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000329</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531843-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041211</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01539</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531844-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004107044</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531845-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01374</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531846-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-12726238</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMPULSIVE BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>DOSE REDUCED TO 10 MG/DAY ON 01-OCT-2004, DISCONTINUED ON 13-OCT-2004</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531847-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12787719</companynumb>
    <primarysource>
      <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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GANGLION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMADESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VASTEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040529</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531848-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-BRISTOL-MYERS SQUIBB COMPANY-12777025</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
        <drugtreatmentduration>324</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIROCORT</medicinalproduct>
        <drugdosagetext>INHALATION</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531849-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040913</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BRISTOL-MYERS SQUIBB COMPANY-12702312</companynumb>
    <primarysource>
      <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>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA IN SITU</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABATACEPT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</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>MISOPROSTOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBICOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030821</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOBRADEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531850-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004109558</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531851-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12796710</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY ALVEOLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531852-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-12790721</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLEOMYCIN SULFATE</medicinalproduct>
        <drugdosagetext>DAYS 2, 9, 16</drugdosagetext>
        <drugindication>TESTIS CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>DAYS 1-5</drugdosagetext>
        <drugindication>TESTIS CANCER</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>DAYS 1-5</drugdosagetext>
        <drugindication>TESTIS CANCER</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531853-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12796900</companynumb>
    <primarysource>
      <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</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>603</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531854-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-368525</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY OCCULT BLOOD POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040303</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugdosagetext>DOSE WAS REDUCED DUE TO ADVERSE EVENT.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040410</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040317</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON A-2A (RO 25-8310)</medicinalproduct>
        <drugdosagetext>DOSE WAS REDUCED DUE TO ADVERSE EVENT.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040421</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE</medicinalproduct>
        <drugdosagetext>STARTED BEFORE PEG INTERFERON ALFA 2A THERAPY. DRUG NAME WAS REPORTED AS: SODIUM 1.4-DIMETHYL-17-SO+</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>STARTED BEFORE PEG INTERFERON ALFA 2A THERAPY. REASON FOR USE: TO TREAT COMPLICATIONS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>STARTED BEFORE PEG INTERFERON ALFA 2A THERAPY. REASON FOR USE: TO TREAT COMPLICATIONS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>STARTED BEFORE PEG INTERFERON ALFA 2A THERAPY. REASON FOR USE: TO TREAT COMPLICATIONS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugdosagetext>STARTED BEFORE PEG INTERFERON ALFA 2A THERAPY. REASON FOR USE: TO TREAT COMPLICATIONS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>STARTED BEFORE PEG INTERFERON ALFA 2A THERAPY. DRUG REPORTER TO BE: LIPITOR ATORVASTATIN (CALCIUM H+</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>REASON FOR USE: TO PREVENT ADR.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531855-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041005012</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>115.21</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATRECOR</medicinalproduct>
        <drugdosagetext>BOLUS 38 ML FOLLOWED BY 11 ML/HOUR INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORACET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B+O SUPPOSITORIES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B+O SUPPOSITORIES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAROXOLYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531856-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE835201JUL04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.8</patientweight>
      <reaction>
        <reactionmeddrapt>SERUM SICKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WYMOX</medicinalproduct>
        <drugauthorizationnumb>62131</drugauthorizationnumb>
        <drugdosagetext>ORA</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIM (ESOMEPRAZOLE0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR (FLUTCASONE PROPIONATE/SALMETEROL XINAFOATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX (MOMETASONE FUROATE0</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531857-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041201688</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS NEUROSENSORY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531858-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041202130</companynumb>
    <primarysource>
      <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>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORALVAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531859-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041202143</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531860-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041204347</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531861-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041202518</companynumb>
    <primarysource>
      <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>ALVEOLITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCAPNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTISKENAN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531862-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041202671</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531863-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041008666</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.13</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0417234</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPROBAMATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531864-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20041202907</companynumb>
    <primarysource>
      <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>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORATED ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531865-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041203222</companynumb>
    <primarysource>
      <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>DELIRIUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUROTEP</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531866-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041203471</companynumb>
    <primarysource>
      <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 CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531867-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041203502</companynumb>
    <primarysource>
      <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>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0416525</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531868-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041203558</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE VESICLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0418016</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531869-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041006909</companynumb>
    <primarysource>
      <qualification>5</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEXPECTED THERAPEUTIC DRUG EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531870-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041102576</companynumb>
    <primarysource>
      <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 CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC SPACE NARROWING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531871-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040807250</companynumb>
    <primarysource>
      <qualification>1</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>APPLICATION SITE BURNING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0415039</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531872-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041204017</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.01</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NARCOTIC INTOXICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531873-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20041204135</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531874-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE853008DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>20527</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531875-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQ9554117DEC2001</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALPHA HAEMOLYTIC STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEPHAROSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMALE REPRODUCTIVE NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIMETAPP</medicinalproduct>
        <drugauthorizationnumb>12436</drugauthorizationnumb>
        <drugdosagetext>ASS NEEDED, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENTEX LA (GUAIFENSIN/PHENYLPROPANOLAMINE  HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRONASE 9GLIBENCLAMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR (BUSPIRONE HYDRCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL (RISEDRONATE0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIJM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (EROCALCIFEROL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531876-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000581</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</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>4531877-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004109059</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531878-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040978448</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC URAEMIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>20509</drugauthorizationnumb>
        <drugdosagetext>1500 MG OTHER</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE (DOXCETAXEL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL (CICLOSTAZOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURICEF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUMEX (BUMETANIDE0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCREASE MT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANZEMET (DOLASETRON MESILATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE (MEGESTROL ACETATE0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531879-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106801</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>117.9352</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ABLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>400 MG (200 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531880-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0395025A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL LOAD INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugbatchnumb>2ZP1170</drugbatchnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531881-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0496761A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531882-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0497995A</companynumb>
    <primarysource>
      <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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040130</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531883-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040226</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0500155A</companynumb>
    <primarysource>
      <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531884-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0503006A</companynumb>
    <primarysource>
      <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 CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEGA 3</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531885-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040409</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0506473A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531886-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040422</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0508095A</companynumb>
    <primarysource>
      <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>SEBORRHOEIC DERMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE + TRIMETHOPRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531887-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0510397A</companynumb>
    <primarysource>
      <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>NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531888-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040722</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0519366A</companynumb>
    <primarysource>
      <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>VIRAL LOAD INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531889-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0520528A</companynumb>
    <primarysource>
      <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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531890-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040813</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0522128A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROXINE FREE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL LOAD INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531891-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0522256A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531892-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0522668A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK THISTLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531893-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040924</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0527307A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531894-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0527385A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531895-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0531281A</companynumb>
    <primarysource>
      <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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040310</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEVIRAPINE</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040229</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040625</drugenddate>
        <drugtreatmentduration>108</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531896-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184446</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GANGRENE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEG AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOE AMPUTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN-HUMAN NPH INSULIN (RDNA) (HUMUAN INSULIN (RD</medicinalproduct>
        <drugbatchnumb>FF3Z16C</drugbatchnumb>
        <drugauthorizationnumb>18780</drugauthorizationnumb>
        <drugdosagetext>30 U DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN-HUMAN NPH INSULIN (RDNA) (HUMUAN INSULIN (RD</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531897-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004109545</companynumb>
    <primarysource></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>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531898-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004034560</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POTASSIUM CHLORIDE SENSITIVITY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RELPAX</medicinalproduct>
        <drugauthorizationnumb>21016</drugauthorizationnumb>
        <drugdosagetext>40 MG (40 MG , ONCE0, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE WITHOUT AURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (VITAMINS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531899-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105674</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>36.2878</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENZYME ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugdosagetext>1.5 MG (0.5 MG, 1 IN 3 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPHAGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531900-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102454</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.0593</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>8762</drugauthorizationnumb>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugdosagetext>(25 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531901-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106548</companynumb>
    <primarysource>
      <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>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>20571</drugauthorizationnumb>
        <drugdosagetext>742 MG (CYCLIC), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB (CETUXIMAB)</medicinalproduct>
        <drugdosagetext>848 MG (CYCLIC), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID (ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL (OLMESARTAN MEDOXOMIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531902-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108089</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRIPLE VESSEL BYPASS GRAFT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531903-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE764006DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>2 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSANT DRUG THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531904-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184719</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>10 MG/1 DAY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531905-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041184844</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PROLACTIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>5 MG/1 DAY</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531906-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108846</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHONDROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG (20 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531907-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108235</companynumb>
    <primarysource></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>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>1 YEAR AGO</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531908-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041284892</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugdosagetext>5 MG DAY</drugdosagetext>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531909-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-12563BP</companynumb>
    <primarysource>
      <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>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugauthorizationnumb>20667</drugauthorizationnumb>
        <drugdosagetext>PO (THERAPY DATES: ABOUT ONE YEAR AGO - NR)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531910-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004103525</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNISOM</medicinalproduct>
        <drugauthorizationnumb>18066</drugauthorizationnumb>
        <drugdosagetext>1/2 TAB ^REGULARLY^, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNISOM</medicinalproduct>
        <drugbatchnumb>0104273</drugbatchnumb>
        <drugdosagetext>1 SLEEPGEL ^REGULARLY^, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531911-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0412108858</companynumb>
    <primarysource>
      <qualification>4</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>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugindication>LOGORRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugindication>TANGENTIALITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>20592</drugauthorizationnumb>
        <drugindication>THINKING ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531912-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW25271</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.986</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>20541</drugauthorizationnumb>
        <drugdosagetext>1 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER RECURRENT</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531913-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104106</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAFFEINE (CAFFEINE)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALL OTHER NON-THERAPEUTIC PRODUCTS (ALL OTHER NON-THERAPEUTIC PRODUCTS</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS ( ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
        <drugdosagetext>NASAL</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>1000 MG (500 M, 2 IN 1 D)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APOREX (DEXTROPROPOXYPHENE HYDROCHLORIDE, PARACETAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN (TERAZOSIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531914-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ATO-04-0886</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>124.7392</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABSCESS ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL CULTURE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE WOUND POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION PSEUDOMONAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRISENOX</medicinalproduct>
        <drugauthorizationnumb>21248</drugauthorizationnumb>
        <drugdosagetext>0.30 MG/KG (0.3 MG/KG, TWICE WEEKLY), IVI</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040903</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531915-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE856708DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR (VENLAFAXINE HYDROCHLORIDE, CAPSULE, SUICIDAL RELEASE)</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>150 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR (VENLAFAXINE HYDROCHLORIDE, CAPSULE, SUICIDAL RELEASE)</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>150 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDAL IDEATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041204</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531916-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108937</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531917-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108839</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531918-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200420997BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPICONDYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLANTAR FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugauthorizationnumb>19537</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>KIDNEY INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531919-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20021114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0386890A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>139.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APRAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGRAPHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILLITERACY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BC MULTI-SYMPTOM ALLERGY SINUS COLD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BC SINUS COLD-PHENYLPROPANOLAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKA SELTZER PLUS COLD</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531920-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200420682BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>107.5025</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXBR9RE1</drugbatchnumb>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
        <drugdosagetext>10 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROCIT-K</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531921-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108016</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531922-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-0007567</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugauthorizationnumb>21356</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIXIVAN</medicinalproduct>
        <drugdosagetext>800 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531923-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200411935BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APALLIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN DAMAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAL BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>400 MG, TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMIG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUDAFED S.A.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531924-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004107962</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531925-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536094A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIOPSY LYMPH GLAND ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19910101</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531926-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536150A</companynumb>
    <primarysource>
      <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>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENSODYNE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>DENTAL CARE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531927-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536159A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>109.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITRUCEL REGULAR SUSPENSION</medicinalproduct>
        <drugbatchnumb>03E190</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531928-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GLAXOSMITHKLINE-A0536821A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIQUITIN</medicinalproduct>
        <drugbatchnumb>0422915-21</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531929-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421756GDDC</companynumb>
    <primarysource>
      <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>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>21MG PER DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531930-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536999A</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>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL SOFT TISSUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORPHYRIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUMS E-X TABLETS, WINTERGREEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUMS SMOOTH DISSOLVE TABLETS, PEPPERMINT</medicinalproduct>
        <drugbatchnumb>3O14</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531931-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537035A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ECOTRIN ADULT LOW STRENGTH TABLETS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>81MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531932-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW25130</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531933-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW20340</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>100 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531934-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0360511A</companynumb>
    <primarysource>
      <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>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531935-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004107931</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531936-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW25167</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531937-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108843</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531938-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE953518MAR04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF ESTEEM DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>75 MG (FREQUENCY UNKNOWN), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531939-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108840</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531940-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE275025NOV03</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>5 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS (CALCIUM CARBONATE/MAGNESIUM CARBONATE/MAGNESIUM TRISILICATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531941-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108829</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531942-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041212</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OXYA20040002</companynumb>
    <primarysource>
      <qualification>2</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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE INVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILLARY REFLEX IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN/OXYCODONE    UNKNOWN       UNKNOWN</medicinalproduct>
        <drugauthorizationnumb>85106</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ PROPOXYPHENE HCL</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531943-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0002544</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.5442</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION SKIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DESQUAMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHYOL</medicinalproduct>
        <drugauthorizationnumb>20221</drugauthorizationnumb>
        <drugdosagetext>500 MG, 5 IN 1 WK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHYOL</medicinalproduct>
        <drugauthorizationnumb>20221</drugauthorizationnumb>
        <drugdosagetext>500 MG, 5 IN 1 WK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RADIOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531944-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041080602</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21411</drugauthorizationnumb>
        <drugdosagetext>40 MG/2 DAY</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20 MG/1 DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040521</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531945-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-US2004-08333</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCLERODERMA</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>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALOXIFENE (RALOXIFENE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531946-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108625</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531947-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US_0410107428</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERPARATHYROIDISM PRIMARY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERIPARATIDE</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG/1 DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531948-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041183479</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>FF4M78B</drugbatchnumb>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531949-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108825</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531950-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2004-07624</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANT SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY 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>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531951-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA040157064</companynumb>
    <primarysource>
      <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>FRACTURE NONUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21318</drugauthorizationnumb>
        <drugdosagetext>20 UG DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531952-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108785</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531953-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A-CH2004-08043</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXANTHEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AUTOIMMUNE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AUTOIMMUNE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AUTOIMMUNE DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AUTOIMMUNE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL (CLOPIDOGREL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE (PYRIDOXINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL (ACENOCOUMAROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAMIDINE (PENTAMIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN (OXYGEN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531954-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108873</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531955-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108822</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE()</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531956-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106651</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531957-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106558</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531958-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>1515-080</companynumb>
    <primarysource>
      <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>VASCULITIS NECROTISING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENOFER</medicinalproduct>
        <drugauthorizationnumb>21135</drugauthorizationnumb>
        <drugdosagetext>IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESLORATIDIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531959-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0002514</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC PH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHYOL</medicinalproduct>
        <drugauthorizationnumb>20221</drugauthorizationnumb>
        <drugdosagetext>500 MG, 5 IN 1 WK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHYOL</medicinalproduct>
        <drugauthorizationnumb>20221</drugauthorizationnumb>
        <drugdosagetext>500 MG, 5 IN 1 WK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPECITABINE (CAPECITABINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANZEMET (DOLASETRON MESILATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531960-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108293</companynumb>
    <primarysource></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>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531961-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041212</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OXYA20040003</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NARCOTIC INTOXICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN/OXYCODONE         UNKNOWN        UNKNOWN</medicinalproduct>
        <drugauthorizationnumb>85106</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531962-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>1515-079</companynumb>
    <primarysource>
      <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>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENOFER</medicinalproduct>
        <drugauthorizationnumb>21135</drugauthorizationnumb>
        <drugdosagetext>200MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENOFER</medicinalproduct>
        <drugauthorizationnumb>21135</drugauthorizationnumb>
        <drugdosagetext>200MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN INTRAVENOUS (HUMAN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531963-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0002483</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117.9352</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHYOL</medicinalproduct>
        <drugauthorizationnumb>20221</drugauthorizationnumb>
        <drugdosagetext>500 MG, 5 IN 1 WK, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RADIOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531964-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108657</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531965-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BP-07053YA</companynumb>
    <primarysource>
      <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>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HARNAL (TAMSULOSIN)</medicinalproduct>
        <drugauthorizationnumb>20579</drugauthorizationnumb>
        <drugdosagetext>0.2 MG (0.2 MG QD), PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLECORUC (CHLORMADINONE ACETATE)</medicinalproduct>
        <drugdosagetext>50 MG (25 MG BID), PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAKAVENSU (MELILOT()</medicinalproduct>
        <drugdosagetext>SEE TEXT (2 DF TID), PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HAEMORRHOIDS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040807</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531966-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041212</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OXYA20040004</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN/OXYCODONE     UNKNOWN     UNKNOWN</medicinalproduct>
        <drugauthorizationnumb>85106</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COCAINE (CRACK)</medicinalproduct>
        <drugdosagetext>OTHER</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531967-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108894</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531968-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PERC20040071</companynumb>
    <primarysource>
      <qualification>2</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>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPIL FIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugauthorizationnumb>40330</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531969-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ENDC20040061</companynumb>
    <primarysource>
      <qualification>2</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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOCET      UNKNOWN     ENDO</medicinalproduct>
        <drugauthorizationnumb>85106</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN/HYDROCORODNE</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALDECOXIB</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531970-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210109</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugdosagetext>1/WEEK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531971-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041212</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PERC20040074</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugauthorizationnumb>40330</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COCAINE</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531972-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA041183202</companynumb>
    <primarysource>
      <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>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APO-METOPROLOL (METOPROLOL TARTRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APO-LISINOPRIL (LISINOPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN (GABAPENTIN PFIZER)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531973-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108928</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531974-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004US-00418</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>76041</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040125</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531975-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108920</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531976-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20021127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-DE-05182DE</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugdosagetext>1 PUF (NR, 1 IN 1 D); IN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCILAC (NR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL (PANTOPRAZOLE SODIUM) (NR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHIN (NR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-THYROXIN (NR)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531977-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-DE-05140DE</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 AIRWAYS DISEASE EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugdosagetext>1 ANZ (NR, 1 IN 1 D); IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>21395</drugauthorizationnumb>
        <drugdosagetext>1 ANZ (NR, 1 IN 1 D); IH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531978-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108907</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531979-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-BE-00099BE</companynumb>
    <primarysource></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>MOVALIS (MELOXICAM) (MELOXICAM)</medicinalproduct>
        <drugauthorizationnumb>20938</drugauthorizationnumb>
        <drugdosagetext>NR</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531980-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108901</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531981-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-DE-06156BY</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KINZALKOMB (MICARDIS HCT)</medicinalproduct>
        <drugauthorizationnumb>21162</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORTIS (NR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPIN (NR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASS PROTECT (NR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISCOVER (CLOPIDOGREL SULFATE) (NR)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531982-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108880</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531983-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004109223</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531984-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>02100-JPN-04-0336</companynumb>
    <primarysource></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>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILOSTAZOL, TICLOPIDINE HYDROCHLORIDE, LITHIUM CARBONATE</medicinalproduct>
        <drugauthorizationnumb>20863</drugauthorizationnumb>
        <drugdosagetext>200 MG; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugdosagetext>200 MG; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>NI; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531985-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE261907DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>75 MG 2X PER 1 DAY; UNKNOWN</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531986-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108797</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531987-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0002526</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>4.0824</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORNEAL REFLEX DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugbatchnumb>402551</drugbatchnumb>
        <drugdosagetext>1 IN 30 D, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531988-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ITWYE282814DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASMAPHERESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOCIN (PIPERACILLIN/TAZOBACTAM, INJECTION)</medicinalproduct>
        <drugauthorizationnumb>50684</drugauthorizationnumb>
        <drugdosagetext>1 G 1X PER 1 DAY; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA KLEBSIELLA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041128</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROXIN (CIPROFLOXACIN, , 0)</medicinalproduct>
        <drugdosagetext>500 MG 2X PER 1 DAY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA KLEBSIELLA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041128</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SURFACTAL (AMBROXOL HYDROCHLORIDE, , 0)</medicinalproduct>
        <drugdosagetext>1 G 1X PER 1 DAY; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA KLEBSIELLA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041128</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT (CALCIUM CARBONATE/CITRIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADESIPRESS TTS (CLONIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUARK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUTIROX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531989-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041216</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108717</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531990-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE181716JUL04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROBACTER BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>2 MG 1X PER 1 DAY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040716</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugdosagetext>3 MG 1X PER 1 DAY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040806</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugdosagetext>2 MG 1X PER 1 DAY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugdosagetext>2 MG 1X PER 1 DAY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531991-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106106</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.1637</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADDICT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTROL</medicinalproduct>
        <drugbatchnumb>FE071A</drugbatchnumb>
        <drugauthorizationnumb>20714</drugauthorizationnumb>
        <drugdosagetext>4-6 CARTRIGES DAILY, INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040520</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531992-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SEWYE271309DEC04</companynumb>
    <primarysource></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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041210</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLVON (MIANSERIN HYDROCHLORIDE, ,0)</medicinalproduct>
        <drugdosagetext>60 MG 1X PER 1 DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531993-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104068</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.3273</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INITIAL INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugauthorizationnumb>5845</drugauthorizationnumb>
        <drugdosagetext>2 TABLETS QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMETIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531994-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12793634</companynumb>
    <primarysource>
      <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>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFRACTORY ANAEMIA WITH AN EXCESS OF BLASTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT RELATED SECONDARY MALIGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531995-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12795233</companynumb>
    <primarysource>
      <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>LICHEN PLANUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVAPRO-HCT TABS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531996-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040708</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12644712</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>109</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK SECOND DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDUCTION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROXINE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROXINE FREE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUDAFED S.A.</medicinalproduct>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN</medicinalproduct>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531997-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE658124JUN04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHILIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTIUM (PANTOPRAZOLE, TABLET, DELAYED RELEASE)</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
        <drugdosagetext>40 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040616</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTIUM (PANTOPRAZOLE, TABLET, DELAYED RELEASE)</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
        <drugdosagetext>40 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040616</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531998-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105622</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TERMINAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROGAINE</medicinalproduct>
        <drugbatchnumb>48MAS</drugbatchnumb>
        <drugauthorizationnumb>19501</drugauthorizationnumb>
        <drugdosagetext>TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HYPOTRICHOSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4531999-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE875509DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EUPANTOL (PANTOPRAZOLE, TABLET, DELAYED RELEASE)</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
        <drugdosagetext>40 MG 1X PER 1 DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PEPTIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040714</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN TRIHYDRATE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PEPTIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040721</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PEPTIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040721</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040709</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532000-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105373</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.7611</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTIZONE-10 (HYDROCORTISONE)</medicinalproduct>
        <drugauthorizationnumb>9176</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED AMOUNT</drugdosagetext>
        <drugindication>PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532001-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE494117NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EXANTHEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMTUZUMAB OZOGAMICIN (GEMTUZUMAB, OZOGAMICIN, INJECTION)</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>10 MG 1X PER 1 DAY INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMTUZUMAB OZOGAMICIN (GEMTUZUMAB, OZOGAMICIN, INJECTION)</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
        <drugdosagetext>10 MG 1X PER 1 DAY INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE (VORICONAZOLE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532002-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-0915</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IRON INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON INJECTABLE</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR (PMPA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE TOPICAL FOR WEIGHT GAIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532003-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FRWYE271409DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21083</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532004-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GBWYE208617NOV04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMTUZUMAB OZOGAMICIN (GEMTUZUMAB OZOGAMICIN, INJECTION)</medicinalproduct>
        <drugauthorizationnumb>21174</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOSINE ARABINOSIDE (CYTARABINE, ,0)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532005-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030218</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F04200400314</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS INFECTIOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALABSORPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>20839</drugauthorizationnumb>
        <drugdosagetext>300 MG ONCE/ 75 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030123</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>20839</drugauthorizationnumb>
        <drugdosagetext>300 MG ONCE/ 75 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030130</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>300 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030130</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532006-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030507</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F04200400312</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>20839</drugauthorizationnumb>
        <drugdosagetext>300 MG ONCE / 75 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030311</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>20839</drugauthorizationnumb>
        <drugdosagetext>300 MG ONCE / 75 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030317</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>300 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030317</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532007-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210957</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIPHOSPHOLIPID SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOLIPIN ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN D DIMER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RUSSELL'S VIPER VENOM TIME ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLATE (FOLATE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OS-CAL +D (CHOLECALCIFEROL, CALCIUM NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532008-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>F04200400313</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>20839</drugauthorizationnumb>
        <drugdosagetext>300 MG ONCE / 300 MG ONCE / 75 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>20839</drugauthorizationnumb>
        <drugdosagetext>300 MG ONCE / 300 MG ONCE / 75 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030110</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>20839</drugauthorizationnumb>
        <drugdosagetext>300 MG ONCE / 300 MG ONCE / 75 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030115</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>300 MG OD / 300 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>300 MG OD / 300 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030115</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE (AMIODARONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532009-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A01200406147</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>20839</drugauthorizationnumb>
        <drugdosagetext>150 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELDENE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532010-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040819</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0523751A</companynumb>
    <primarysource>
      <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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030516</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532011-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0536962A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugdosagetext>1.4MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA OF THE CERVIX</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041209</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN LOWER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN LOWER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE 0.9%</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532012-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537080A</companynumb>
    <primarysource>
      <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>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHATIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532013-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537452A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532014-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537632A</companynumb>
    <primarysource>
      <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>BENIGN INTRACRANIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532015-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537637A</companynumb>
    <primarysource>
      <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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532016-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>12779849</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugdosagetext>38.8MG CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>77.6MG CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1940MG CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPAFENONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENISTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532017-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537766A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532018-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537805A</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>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugdosagetext>150MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSTHYMIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031017</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532019-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A01200406059</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORY NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>20839</drugauthorizationnumb>
        <drugdosagetext>300 MG LOADING DOSE, THEN 75 MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGIOPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>20839</drugauthorizationnumb>
        <drugdosagetext>300 MG LOADING DOSE, THEN 75 MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>20839</drugauthorizationnumb>
        <drugdosagetext>300 MG LOADING DOSE, THEN 75 MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532020-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A02200403448</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLACTACIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IATROGENIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ALKALOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLE ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugauthorizationnumb>9768</drugauthorizationnumb>
        <drugdosagetext>400 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>50 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT D3 (CALCIUM/COLECALCIFEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532021-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537807A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532022-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004/02747</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532023-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0316164A</companynumb>
    <primarysource>
      <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>HAEMORRHAGE SUBCUTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031106</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBAMIPIDE</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031106</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIINFLAMMATORY THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031106</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031106</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532024-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GLAXOSMITHKLINE-B0322008A</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES PALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROPAX</medicinalproduct>
        <drugdosagetext>20MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040107</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532025-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040211</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0322994A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENIERE'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMETIDINE</medicinalproduct>
        <drugdosagetext>400MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040204</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFTAVAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040114</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNARIZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPTAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031113</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532026-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-122776-NL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>21208</drugauthorizationnumb>
        <drugdosagetext>DF</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532027-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0323932A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENIERE'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMETIDINE</medicinalproduct>
        <drugdosagetext>400MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040204</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532028-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A02200403615</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugauthorizationnumb>20839</drugauthorizationnumb>
        <drugdosagetext>75 MG OD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532029-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0323980A</companynumb>
    <primarysource>
      <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>BRAIN CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL BONES FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugdosagetext>150MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUANXOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532030-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040901</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0344490A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040810</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADETPHOS</medicinalproduct>
        <drugdosagetext>180MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE S</medicinalproduct>
        <drugdosagetext>1.5G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUZEN-TAIHO-TO</medicinalproduct>
        <drugdosagetext>7.5G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532031-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0347114A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>1G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040906</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIFLOX</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040906</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugdosagetext>40MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KABIVEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PARENTERAL NUTRITION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERNEVIT-12</medicinalproduct>
        <drugindication>PARENTERAL NUTRITION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NONAN</medicinalproduct>
        <drugindication>PARENTERAL NUTRITION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT B1</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532032-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0347542A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PIGMENTATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TEMPOROMANDIBULAR JOINT SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERCINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532033-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-GLAXOSMITHKLINE-B0348404A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMPRENAVIR</medicinalproduct>
        <drugdosagetext>700MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>6CAP PER DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugdosagetext>90MG TWICE PER DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugdosagetext>300MG TWICE PER DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031216</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532034-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0350588A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRERAN</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENALIN</medicinalproduct>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
        <drugdosagetext>6MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>3.6G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MALFA</medicinalproduct>
        <drugdosagetext>3.6G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EURODIN</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SHAKUYAKU-KANZO-TO</medicinalproduct>
        <drugdosagetext>7.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE CRAMP</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040821</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041030</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532035-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0351001A</companynumb>
    <primarysource>
      <qualification>2</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS</medicinalproduct>
        <drugdosagetext>2MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN</medicinalproduct>
        <drugdosagetext>80MG IN THE MORNING</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300MG IN THE MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>10MG IN THE MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50MG IN THE MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532036-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0351247A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN 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>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugdosagetext>.5G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugdosagetext>50MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERENACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROXAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGIZONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA ASPERGILLUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSULFAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041009</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532037-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GLAXOSMITHKLINE-B0357358A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532038-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0357468A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>10</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADRENAL SUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ELECTROLYTES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE SODIUM SUCCINATE</medicinalproduct>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040210</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040204</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532039-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-GLAXOSMITHKLINE-B0357627A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CRANIAL NERVE PALSIES MULTIPLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGEMINAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIIITH NERVE LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEFFIX</medicinalproduct>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>180MCG WEEKLY</drugdosagetext>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532040-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0358509A</companynumb>
    <primarysource>
      <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>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELLS URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532041-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0359221A</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLACTACIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KAPOSI'S SARCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030213</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR SULPHATE</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020423</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-TRIMOXAZOLE</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMOCYSTIS CARINII PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020325</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532042-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KE-GLAXOSMITHKLINE-B0360516A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITOCHONDRIAL CYTOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITTING OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugindication>TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugindication>TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRAZINAMIDE</medicinalproduct>
        <drugindication>TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HYDROCHLORIDE</medicinalproduct>
        <drugindication>TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON SALT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532043-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BRO-007970</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IOPAMIDOL</medicinalproduct>
        <drugbatchnumb>43756</drugbatchnumb>
        <drugauthorizationnumb>18735</drugauthorizationnumb>
        <drugdosagetext>100 ML IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>807</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532044-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>THQ2004A01032</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>20406</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC (DICLOFENAC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532045-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0360618A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUTISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STUPOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTANE</medicinalproduct>
        <drugdosagetext>2MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLANAX</medicinalproduct>
        <drugdosagetext>.4MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILECE</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugdosagetext>12MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532046-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0361270A</companynumb>
    <primarysource>
      <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>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELLARIL</medicinalproduct>
        <drugdosagetext>7UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>160MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OROCAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INHALED BETA-2 AGONIST (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RULID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040902</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESPIRATORY PHYSIOTHERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030922</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532047-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0361794A</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUCEF</medicinalproduct>
        <drugdosagetext>1G TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ISCHAEMIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERIZYM</medicinalproduct>
        <drugdosagetext>3 PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAC B</medicinalproduct>
        <drugdosagetext>1G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532048-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-GLAXOSMITHKLINE-B0361822A</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVOSTIN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIPREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEO-MERCAZOLE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BURINEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALEORID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVOSTIN</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOKILAN</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN ACTRAPID</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN INSULATARD NPH NORDISK</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532049-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0361928A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRANULOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>1G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTRAPID</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOMIX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532050-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0362053A</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMIJECT</medicinalproduct>
        <drugdosagetext>6MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANGIOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPITOMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGIOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGENE</medicinalproduct>
        <drugindication>ANGIOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532051-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-GLAXOSMITHKLINE-B0362071A</companynumb>
    <primarysource>
      <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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>25MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041203</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>100MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MANIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532052-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-GLAXOSMITHKLINE-B0362077A</companynumb>
    <primarysource>
      <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>CHAPPED LIPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MUCOSAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SECRETION DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERINFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>3TC</medicinalproduct>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugdosagetext>245MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugdosagetext>1DROP THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>CONJUNCTIVITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532053-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>387854</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>102</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILATREND</medicinalproduct>
        <drugdosagetext>6MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040224</drugenddate>
        <drugtreatmentduration>374</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UBIDECARENONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTRIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOCLOBEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GTN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532054-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0362099A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXANTHEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADIAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMALINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEDERFOLINE</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MALOCIDE</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532055-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0362118A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040524</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHIBRO-CADRON</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>UVEITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYDRIATICUM</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>UVEITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>UVEITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532056-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>387882</companynumb>
    <primarysource>
      <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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KREDEX</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532057-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040913</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0044673A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELMENDOS</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532058-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0045366A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>850MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOR</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugdosagetext>20MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532059-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-0007769</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugauthorizationnumb>21356</drugauthorizationnumb>
        <drugdosagetext>300 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532060-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003-06430</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugdosagetext>300 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugdosagetext>400 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugdosagetext>2 IN 1 D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030313</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532061-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW25137</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532062-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-0007394</companynumb>
    <primarysource>
      <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>NEPHROGENIC DIABETES INSIPIDUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugauthorizationnumb>21356</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532063-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>J081-002-001798</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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCREATININAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OILY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUP-4 (PROPIVERINE HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>60 MG, 3 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVISHOT (NAFTOPIDIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532064-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW25180</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100.2449</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>400 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532065-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A044-002-005204</companynumb>
    <primarysource>
      <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 FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK LEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDUCTION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>20690</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532066-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A044-002-005357</companynumb>
    <primarysource>
      <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>PSYCHOTIC DISORDER</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>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-CODAMOL (PANADEINE CO)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPTAC (PEPTAC)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532067-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW25363</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>200 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532068-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE05692</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESSENTIALE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532069-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW20769</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugdosagetext>20 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532070-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW18156</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>115.4404</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DROOLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugindication>SUICIDAL IDEATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532071-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW25001</companynumb>
    <primarysource></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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532072-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-CAN-06658-01</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
        <drugauthorizationnumb>20401</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532073-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040526</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW11075</companynumb>
    <primarysource>
      <qualification>3</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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>400 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532074-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12784559</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE RUPTURE OF MEMBRANES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TWIN PREGNANCY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
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    </patient>
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    <safetyreportid>4532075-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12785408</companynumb>
    <primarysource>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>4532076-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-UKI-08105-01</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 WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRALEX (ESCITALOPRAM)</medicinalproduct>
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        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRALEX (ESCITALOPRAM)</medicinalproduct>
        <drugdosagetext>10 MG QOD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN V ^ALIUD PHARMA^ (PHENOXYMETHYLPENICILLIN POTASSIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532077-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW24821</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>300-400 MG DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532078-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-SWI-08103-01</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD OSMOLARITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041009</drugenddate>
      </drug>
      <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>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND HCT</medicinalproduct>
        <drugdosagetext>6.25 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELOC ZAK (METOPROLOL SUCCINATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AXOTIDE (FLUTICASONE PROPIONATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532079-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12767240</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INCREASED APPETITE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532080-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-UKI-07826-01</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASPHYXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICOLOGIC TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>60 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532081-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-UKI-08104-01</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GESTATIONAL DIABETES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRAMIL (CITALOPRAM)</medicinalproduct>
        <drugauthorizationnumb>20822</drugauthorizationnumb>
        <drugdosagetext>20 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532082-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>167-20785-04100512</companynumb>
    <primarysource>
      <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>AXILLARY VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE - PHARMION (THALIDOMIDE) (100 MILLIGRAM, CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE (GEMCITABINE)</medicinalproduct>
        <drugdosagetext>1976 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE (GEMCITABINE)</medicinalproduct>
        <drugdosagetext>1976 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>590 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532083-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>090-20785-04110644</companynumb>
    <primarysource>
      <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>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHRONIC ACTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA KLEBSIELLA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL LOAD INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532084-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>167-20785-04120176</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE - PHARMION (THALIDOMIDE) (100 MILLIOGRAM, CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>720 MG, DAILY, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532085-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0338</companynumb>
    <primarysource>
      <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>CONVERSION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELESTONE</medicinalproduct>
        <drugauthorizationnumb>14215</drugauthorizationnumb>
        <drugdosagetext>140 DROPS QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532087-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0287</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>10 MIU TIW SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532088-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0408</companynumb>
    <primarysource>
      <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>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>250 MG/M2 ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532089-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-01-0173</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIBODY TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC URAEMIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAPTOGLOBIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MESENTERIC OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>KAPOSI'S SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>KAPOSI'S SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>KAPOSI'S SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPIATE AND OPIOID ANELGESIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532090-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-05151</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYDROCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCROTAL SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRELSTAR</medicinalproduct>
        <drugauthorizationnumb>21288</drugauthorizationnumb>
        <drugdosagetext>11.25 MG/M3 MONTHS, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLY-KARAYA (STERCULIA, POLYVIDONE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532091-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-0007716</companynumb>
    <primarysource>
      <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>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRICITABINE (EMTRICITABINE)</medicinalproduct>
        <drugauthorizationnumb>21500</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE (TENOFOVIR DISOPROXIL FUMARATE)</medicinalproduct>
        <drugdosagetext>300 MG, 1 IN 1D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRISEOFULVIN (GRISEOFULVIN) (250 MG)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOCRIN (EFAVIRENZ)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEFOL (FEFOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICYNONE (ETAMSILATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532092-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>D01200401661</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST WALL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>74735</drugauthorizationnumb>
        <drugdosagetext>80 MG/M2 CONT - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER EXTENSIVE STAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>120 MG/M2 GIVEN ON DAYS 1, 2, AND 3, IN A 30-MINUTE INFUSION - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER EXTENSIVE STAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN-FRACTION, SODIUM SALT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TROPISETRON HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRPOFLOXACIN HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532093-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-0098PO</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>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PONTAL (MEFANIMIC ACID)/PONSTEL NDA 15-034</medicinalproduct>
        <drugauthorizationnumb>15034</drugauthorizationnumb>
        <drugdosagetext>250 MG, BID, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PONTAL (MEFANIMIC ACID)/PONSTEL NDA 15-034</medicinalproduct>
        <drugauthorizationnumb>15034</drugauthorizationnumb>
        <drugdosagetext>250 MG, BID, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM (LOXOPROFEN SODIUM)</medicinalproduct>
        <drugdosagetext>60 MG, TID, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFACLOR</medicinalproduct>
        <drugdosagetext>250 MG TID, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFCAPENE PIVOXIL HYDROCHLORIDE (CEFCAPENE PIVOXIL HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>100 MG TID, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFCAPENE PIVOXIL HYDROCHLORIDE (CEFCAPENE PIVOXIL HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>100 MG TID, PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugdosagetext>25 MG, BID, RECTALLY</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532094-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05785</companynumb>
    <primarysource></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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SQUAMOUS CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUROTEP JANSSEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPEMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532095-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP06222</companynumb>
    <primarysource></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>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG QOD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBESSER ^DELTA^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532096-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP06092</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE SUBCUTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>19726</drugauthorizationnumb>
        <drugdosagetext>3.6 MG Q4WK SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ODYNE</medicinalproduct>
        <drugdosagetext>375 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532097-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004PK02081</companynumb>
    <primarysource>
      <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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOENCEPHALOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>19726</drugauthorizationnumb>
        <drugdosagetext>3.6 MG Q4WK SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN ^RATIOPHARM^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532098-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05894</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugauthorizationnumb>20498</drugauthorizationnumb>
        <drugdosagetext>80 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugdosagetext>11.25 MG Q3MO SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030926</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532099-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041203486</companynumb>
    <primarysource>
      <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>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFRACTORY ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLADRIBINE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981123</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLADRIBINE</medicinalproduct>
        <drugdosagetext>7 CONSECUTIVE DAYS, EVERY 4 WEEKS, UP TO A MAXIMUM OF 6 CYCLES</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981123</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532100-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041203580</companynumb>
    <primarysource>
      <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>FOLLICLE CENTRE LYMPHOMA, FOLLICULAR GRADE I, II, III REFRACTORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLADRIBINE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>MYCOSIS FUNGOIDES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLADRIBINE</medicinalproduct>
        <drugdosagetext>7 CONSECUTIVE DAYS, EVERY 4 WEEKS, UP TO A MAXIMUM OF 6 CYCLES</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>CHOP THERAPY REGIMEN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>CHOP THERAPY REGIMEN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>CHOP THERAPY REGIMEN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>CHOP THERAPY REGIMEN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532101-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041203586</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLADRIBINE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>MYCOSIS FUNGOIDES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLADRIBINE</medicinalproduct>
        <drugdosagetext>7 CONSECUTIVE DAYS, EVERY 4 WEEKS, UP TO A MAXIMUM OF 6 CYCLES</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532102-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041203587</companynumb>
    <primarysource>
      <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>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLADRIBINE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLADRIBINE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLADRIBINE</medicinalproduct>
        <drugdosagetext>7 CONSECUTIVE DAYS, EVERY 4 WEEKS, UP TO A MAXIMUM OF 6 CYCLES</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532103-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041203588</companynumb>
    <primarysource>
      <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>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFRACTORY ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLADRIBINE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLADRIBINE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLADRIBINE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLADRIBINE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLADRIBINE</medicinalproduct>
        <drugdosagetext>7 CONSECUTIVE DAYS, EVERY 4 WEEKS, UP TO A MAXIMUM OF 6 CYCLES</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>MYCOSIS FUNGOIDES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532104-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041203924</companynumb>
    <primarysource>
      <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>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFRACTORY ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLADRIBINE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLADRIBINE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLADRIBINE</medicinalproduct>
        <drugdosagetext>7 CONSECUTIVE DAYS, EVERY 4 WEEKS, UP TO A MAXIMUM OF 6 CYCLES</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532105-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004UW10204</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STUPOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>112.5 MG - 150 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGGRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532106-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004PK02100</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugdosagetext>800 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532107-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-04-0520</companynumb>
    <primarysource>
      <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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTAMIDE</medicinalproduct>
        <drugauthorizationnumb>18554</drugauthorizationnumb>
        <drugdosagetext>250 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugdosagetext>11.25-3.75 MG SUBCUTANEO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESILATE ORALS</medicinalproduct>
        <drugdosagetext>2.5 MG/DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOGLIBOSE ORALS</medicinalproduct>
        <drugdosagetext>0.9-0.6MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISTIGMINE BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532108-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE06435</companynumb>
    <primarysource></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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugdosagetext>4 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>8 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESLANOSIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMETIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532109-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE01592</companynumb>
    <primarysource></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>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugdosagetext>8 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>6 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>5 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>15 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532110-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE04671</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <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>LYMPHOCYTE STIMULATION TEST NEGATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugdosagetext>8 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIDAPRIL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EDARAVONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARGATROBAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIPINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532111-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>211064</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532112-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05862</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532113-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05958</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE FEBRILE NEUTROPHILIC DERMATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG ADENOCARCINOMA STAGE IV</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532114-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP06004</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugbatchnumb>0324</drugbatchnumb>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532115-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004GB02993</companynumb>
    <primarysource>
      <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>CORNEAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEFITINIB</medicinalproduct>
        <drugauthorizationnumb>21399</drugauthorizationnumb>
        <drugdosagetext>250 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532116-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP06107</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugauthorizationnumb>18240</drugauthorizationnumb>
        <drugdosagetext>50 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNRYTHM</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOSIN</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040108</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532117-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE06799</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugdosagetext>40 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532118-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>K200401857</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDETTE-21</medicinalproduct>
        <drugauthorizationnumb>18668</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>VARIABLE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AORTIC VALVE REPLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532119-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>K200401873</companynumb>
    <primarysource>
      <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>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>19901</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532120-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>K200401876</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXANTHEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugauthorizationnumb>19901</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSEC MUPS (OMEPRAZOLE MAGNESIUM)</medicinalproduct>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FURIX (FUROSEMIDE) TABLET, 40MG</medicinalproduct>
        <drugdosagetext>40 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELOKEN ZOC (METOPROLOL SUCCINATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROMEX (GLYCERYL TRINITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUROFERON (FERROUS SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K CL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSCARD (GLYCERYL TRINITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532121-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004PK02081</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOENCEPHALOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>19726</drugauthorizationnumb>
        <drugdosagetext>3.6 MG Q4WK SQ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532122-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE06830</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL SPHINCTER ATONY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAROPIN</medicinalproduct>
        <drugauthorizationnumb>20533</drugauthorizationnumb>
        <drugindication>EPIDURAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532123-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP06250</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPEN</medicinalproduct>
        <drugauthorizationnumb>50706</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040330</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532124-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0303</companynumb>
    <primarysource>
      <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>FEMORAL NECK FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE ORAL AEROSOL 'LIKE VANCERIL'</medicinalproduct>
        <drugauthorizationnumb>17573</drugauthorizationnumb>
        <drugdosagetext>0.15MG QD ORAL AER INH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERBUTALINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532125-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210683</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>150 MG , SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532126-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SGB1-2004-00423</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANAGRELIDE HCL</medicinalproduct>
        <drugdosagetext>1.5 MG, 1X/DAY: QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL THROMBOCYTHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTOXIFYLLINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532127-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004VX000934</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>12209</drugauthorizationnumb>
        <drugdosagetext>125 MG; INTRA-ARTERIAL</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON-A (GENERIC UNKNOWN)</medicinalproduct>
        <drugdosagetext>5000000 IU; SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAIXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HARNAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532128-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>230055M04GBR</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MCG, 3 IN 1 WEEKS, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532129-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0253</companynumb>
    <primarysource>
      <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>AREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUGULAR VEIN DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPIL FIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF-MEDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugauthorizationnumb>19658</drugauthorizationnumb>
        <drugdosagetext>1 TABLET QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATOPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROX TABLETS</medicinalproduct>
        <drugdosagetext>75 UG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYSANXIA TABLETS</medicinalproduct>
        <drugdosagetext>10 MG TID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>37 MG TID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IXEL (MILNACIPRAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTEN (PRAVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC SACHETS (ACETYLSALICYLATE LYSINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532130-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-0013</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugauthorizationnumb>19658</drugauthorizationnumb>
        <drugdosagetext>10 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041030</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTIDE (FLUTICASONE PROPIONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE NASAL SOLUTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532131-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>211097</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC STRESS TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>370 MG, 1/ WEEK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040425</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532132-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410761BNE</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>21400</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532133-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410610BYL</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugauthorizationnumb>20198</drugauthorizationnumb>
        <drugdosagetext>20 MG , BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TSUMURA SHOU SEI RYUTO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGAMTYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENIRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVAMYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRYPTANOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARAMIDIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532134-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410559BNE</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN PLUS PLACEBO (MOXIFLOXACIN)</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PELVIC INFLAMMATORY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532135-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410509BNE</companynumb>
    <primarysource></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>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN PLUS PLACEBO (MOXIFLOXACIN)</medicinalproduct>
        <drugbatchnumb>C7 1856/1</drugbatchnumb>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PELVIC INFLAMMATORY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040725</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532136-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-0582</companynumb>
    <primarysource>
      <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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>21029</drugauthorizationnumb>
        <drugdosagetext>120 MG /DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATS CLAW (UNCARIA TOMENTOSA/GUIANENSIS) CAPSULES</medicinalproduct>
        <drugdosagetext>3 G/DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENIUM TRACE METAL ADDITIVE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532137-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0181</companynumb>
    <primarysource>
      <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>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>6 MU TIW INTRAMUSCULAR</drugdosagetext>
        <drugindication>CHRONIC HEPATITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOLAN TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN (MOSAPRIDE CITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOKUNALIN TRANSDERMAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOGAR (LAFUTIDINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532138-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-07-0006</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAFERONPEG</medicinalproduct>
        <drugdosagetext>80 MCG QW SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>600 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532139-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040405</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12557617</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugdosagetext>13-SEP-2000: 10MG/D; 13-OCT-2000: 20MG/D; 16-FEB-2001: 30MG/D; 17-AUG-2001: 40MG/D</drugdosagetext>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</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>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugdosagetext>DOSAGE FORM = TABLETS</drugdosagetext>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENTE INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532140-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12765947</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN AQ</medicinalproduct>
        <drugbatchnumb>4F89061</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANZEMET</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532141-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12763405</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN AQ</medicinalproduct>
        <drugbatchnumb>4F88043</drugbatchnumb>
        <drugdosagetext>ADDITIONAL LOT #4F89061 EXP. 12/05</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532142-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040420</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-BRISTOL-MYERS SQUIBB COMPANY-12565396</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>ENDOMETRIAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugindication>ENDOMETRIAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040408</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532143-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12798328</companynumb>
    <primarysource>
      <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>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT RELATED SECONDARY MALIGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEPESID</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN</medicinalproduct>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELSPAR</medicinalproduct>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>6-MP</medicinalproduct>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARA-C</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532144-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>00/00290-FRA</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGAMMAGLOBULINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE+CYCLOPHOSPHAMIDE (FLUDARABINE ORAL+CYCLOPHOSPHAMIDE) (FLUD</medicinalproduct>
        <drugauthorizationnumb>20038</drugauthorizationnumb>
        <drugdosagetext>RESPECTIVELY 30 MG/M2, AND 200 MG , ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESBERIVEN (MELILOTUS OFFICINALIS, RUTOSIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIFFU K</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532145-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-2004-036108</companynumb>
    <primarysource>
      <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 TOLERANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JASMINE(DROSPIRENONE,  ETHINYLESTRADIOL) FILM TABLET</medicinalproduct>
        <drugauthorizationnumb>21098</drugauthorizationnumb>
        <drugdosagetext>1 TAB(S), 21D/28D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532146-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004107891</companynumb>
    <primarysource>
      <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>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugauthorizationnumb>12151</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA BLOCKING AGENTS (BETA BLOCKING AGENTS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532147-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200411013BVD</companynumb>
    <primarysource></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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALKALOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ALKALOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ALKALOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COMPLETED SUICIDE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532148-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041202830</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>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532149-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041203062</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PROLACTIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITUITARY TUMOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532150-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041203147</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532151-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040902332</companynumb>
    <primarysource>
      <qualification>1</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>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532152-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040809752</companynumb>
    <primarysource>
      <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>PROSTATE CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532153-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041200939</companynumb>
    <primarysource>
      <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 CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATATONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBIN BLOOD INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETIT MAL EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNITRAZEPAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPIRIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHINESE MEDICINES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532154-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041003910</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBIN BLOOD INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugbatchnumb>04BS62G</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugbatchnumb>04BS62G</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugindication>PARKINSONISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFARLEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532155-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413376GDS</companynumb>
    <primarysource></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>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532156-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410616BNE</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOROIDAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE OPERATION COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPHAEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugdosagetext>75 MG , TOTAL DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532157-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413382GDS</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIFLOX (CIPROFLOXAIN)</medicinalproduct>
        <drugauthorizationnumb>19537</drugauthorizationnumb>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-DIABETICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532158-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413371GDS</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELIDS PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>19537</drugauthorizationnumb>
        <drugdosagetext> 500 MG , TOTAL DAILY,ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532159-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2004-035815</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040709</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532160-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041202568</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532161-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041202846</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>PARANOIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532162-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2004-033678</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030815</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532163-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2004-031456</companynumb>
    <primarysource>
      <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>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGIOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030525</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532164-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2004-036169</companynumb>
    <primarysource>
      <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>FAT NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAFERON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532165-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-2004-036240</companynumb>
    <primarysource>
      <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>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAFERON</medicinalproduct>
        <drugdosagetext>8 MIU, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532166-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-2004-036235</companynumb>
    <primarysource>
      <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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTRAST MEDIA REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 300</medicinalproduct>
        <drugbatchnumb>41078B</drugbatchnumb>
        <drugauthorizationnumb>20220</drugauthorizationnumb>
        <drugdosagetext>100 ML, 1 DOSE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532167-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004JP15251</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.0234</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISUDYNE</medicinalproduct>
        <drugauthorizationnumb>21119</drugauthorizationnumb>
        <drugdosagetext>4.5 MG DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMEDIN CAPSULE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532168-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>01/00078-FRA</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRONCHOSCOPY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOCAL NODULAR HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE+CYCLOPHOSPHAMIDE (FLUDARABINE ORAL + CYCLOPHOSPHAMIDE) (FL</medicinalproduct>
        <drugauthorizationnumb>20038</drugauthorizationnumb>
        <drugdosagetext>RESPECTIVELY 30 MG/M2 AND 200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA STAGE 1</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPHREN (ONDANSETRON)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL (BROMAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSIPEG (MACROGOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532169-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-JNJFOC-20041202500</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EBIXA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>77</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532170-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041203031</companynumb>
    <primarysource>
      <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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532171-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106461</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESUSCITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
        <drugauthorizationnumb>20287</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DISSEMINATED INTRAVASCULAR COAGULATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMINOFLUID (AMINO ACIDS NOS, ELECTROLYTES NOS, GLUCOSE)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXATIDINE ACETATAE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532172-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004111463</companynumb>
    <primarysource>
      <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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS MEMBRANOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DISOPYRAMIDE PHOSPHATE CAPSULE (DISOPYRAMIDE PHOSPHATE)</medicinalproduct>
        <drugauthorizationnumb>17447</drugauthorizationnumb>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCAINAMIDE HCL</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAXOLOL</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532173-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004235886JP</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>20571</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGAFUR (TEGAFUR)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOGLICOSE (VOGIBLOSE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532174-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-2004-035282</companynumb>
    <primarysource></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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 370</medicinalproduct>
        <drugbatchnumb>42662A</drugbatchnumb>
        <drugauthorizationnumb>20220</drugauthorizationnumb>
        <drugdosagetext>80 ML, 1 DOSE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SCAN BRAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532175-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2004-036154</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PETIT MAL EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVONORGESTREL AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>20860</drugauthorizationnumb>
        <drugdosagetext>1 TAB(S), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532176-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-2004-036322</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLIGHTED OVUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532177-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-2004-036145</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FURUNCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>21098</drugauthorizationnumb>
        <drugdosagetext>1 TAB(S), 1X/DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532178-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-2004-036460</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SCLERITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>21225</drugauthorizationnumb>
        <drugdosagetext>20 UG/DAY, CONT, INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532179-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004110267</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARBOHYDRATE ANTIGEN 19-9 INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532180-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004110216</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48.9885</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF LIBIDO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>150 MG (150 MG FIRST INJECTION, EVERY 10-13 WEEKS), INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>150 MG (150 MG FIRST INJECTION, EVERY 10-13 WEEKS), INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL (SALBUTAMOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532181-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004093107</companynumb>
    <primarysource>
      <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>MENINGITIS PNEUMOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFPODOXIME PROXETIL SUSPENSION (CEFPODOXIME PROXETIL)</medicinalproduct>
        <drugauthorizationnumb>50675</drugauthorizationnumb>
        <drugdosagetext>TWICE BEFORE HOSPITALIZATION ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFPODOXIME PROXETIL SUSPENSION (CEFPODOXIME PROXETIL)</medicinalproduct>
        <drugauthorizationnumb>50675</drugauthorizationnumb>
        <drugdosagetext>TWICE BEFORE HOSPITALIZATION ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532182-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004109314</companynumb>
    <primarysource>
      <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>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DALTEPARIN (DALTEPARIN)</medicinalproduct>
        <drugauthorizationnumb>20287</drugauthorizationnumb>
        <drugdosagetext>2500 UNITS (2500 UNITS, OD), SUBCUTANEOUS  1 MTH BACK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532183-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004110372</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugbatchnumb>LF0188</drugbatchnumb>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>1ST INJECTION, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugbatchnumb>LF0188</drugbatchnumb>
        <drugauthorizationnumb>20246</drugauthorizationnumb>
        <drugdosagetext>1ST INJECTION, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532184-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004109326</companynumb>
    <primarysource>
      <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>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DALTEPARIN (DALTEPARIN)</medicinalproduct>
        <drugauthorizationnumb>20287</drugauthorizationnumb>
        <drugdosagetext>2500 UNITS (2500 UNITS, OD), SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532185-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004107949</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCRATCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DESQUAMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRONOLACTON (SPIRONOLACTONE)</medicinalproduct>
        <drugauthorizationnumb>12151</drugauthorizationnumb>
        <drugdosagetext>25 MG (50 MG, DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugdosagetext>200 MG (10 MG, BID), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>160 MG (160 MG, DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAFTIDROFURYL (NAFTIDROFURYL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN (DIGOXN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOMYCIN SULFATE (NEOMYCIN SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN (TAMSULOSIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESLORATADINE (DESLORATIDINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532186-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108938</companynumb>
    <primarysource>
      <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>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID SOLUTION, STERILE (LINEZOLID)</medicinalproduct>
        <drugauthorizationnumb>21131</drugauthorizationnumb>
        <drugdosagetext>1200 MG (600 MG, BID), INTRAVEOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPERACILLIN</medicinalproduct>
        <drugdosagetext>8 G (4 GRAM, BID), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOBACTAM</medicinalproduct>
        <drugdosagetext>1000 MG (500 MG, BID), INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPASFON (PHLOROGLUCINOL, TRIMETHYLPHLOROGLUCINOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYTONADIONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODEOXYCHOLIC ACID (URODEOXYCHOLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B1 AND B6 (PYRIDOXINE, THIAMINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532187-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004107152</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUTANEOUS LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REACTION TO DRUG EXCIPIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>5 MG (5MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011025</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532188-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004107124</companynumb>
    <primarysource>
      <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 HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SILDENAFIL (SILDENAFIL)</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>50 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532189-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004098571</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXANTHEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHONCHI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>50710</drugauthorizationnumb>
        <drugdosagetext>500 MG (250 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532190-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105915</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>10 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN (ROSUVASTATIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532191-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004102828</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB (CELECOXIB)</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>100 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE (CODEINE PHOSPHATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532192-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104166</companynumb>
    <primarysource>
      <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>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS CANDIDA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC CANDIDA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugauthorizationnumb>19949</drugauthorizationnumb>
        <drugindication>ENDOCARDITIS CANDIDA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugauthorizationnumb>19949</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>120 MG (60 NMG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG ABUSER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE (VORICONAZOLE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532193-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004239511DE</companynumb>
    <primarysource>
      <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>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugauthorizationnumb>20664</drugauthorizationnumb>
        <drugdosagetext>8 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OLIVOPONTOCEREBELLAR ATROPHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS (DIURETICS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532194-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004110584</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugauthorizationnumb>7073</drugauthorizationnumb>
        <drugdosagetext>500 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASASANTIN (ACETYLSALICYLIC ACID, DIPYRIDAMOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532195-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004065204</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR COLOUR CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIRSUTISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>INTERVAL: EVERY DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG (40 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugdosagetext>EVERY DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532196-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004094193</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRUSHING INJURY OF HIP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>5 MG (5 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTOXIFYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532197-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>033-0981-M0000499</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRODUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG (1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ISCHAEMIC HEART DISEASE PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID (INSULIN HUMAN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532198-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004091315</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABYRINTHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYZINE HCL</medicinalproduct>
        <drugauthorizationnumb>11768</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532199-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2003123385</companynumb>
    <primarysource>
      <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>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BAND NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD FIBRINOGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTE ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPID METABOLISM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>5 MG (DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>5 MG (PER DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOTEROL HYDROBROMIDE (FENOTEROL HYDROBROMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBROXOL HYDROCHLORIDE (AMBROXOL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPRAZINONE HYDROCHLORIDE (EPRAZINONE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELESTAMINE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUPLATAST TOSILATE (SUPLATAST TOSILATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE A+B (SENNOSIDE A+B)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXATOMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PL GRAN. (CAFFEINE, SALICYLAMIDE, PARACETAMOL PROMETHAZINE METHYLENE D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532200-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004099922</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugauthorizationnumb>19835</drugauthorizationnumb>
        <drugdosagetext>10 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXATOMIDE</medicinalproduct>
        <drugdosagetext>60 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugdosagetext>200 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
        <drugdosagetext>100 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URTICARIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532201-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105722</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTIBODY TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDUCTION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR (ATORVASTATIN)</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>80 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532202-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106095</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>50 MG (50 MG, 1 AS NECESSARY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532203-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101346</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>119</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVASTATIN (FLUVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL (ACENOCOUMAROL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532204-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108085</companynumb>
    <primarysource>
      <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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>(4 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532205-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>00/00416-FRA</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE + CYCLOPHOSPHAMIDE (FLUDARABINE PHOSPHATE)</medicinalproduct>
        <drugauthorizationnumb>20038</drugauthorizationnumb>
        <drugdosagetext>RESPECTIVELY 30 MG/M2 AND 200MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRO-DAFALGAN (PROPACETAMOL HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLUPSAN (CARBASALATE CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDALIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532206-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-2004-036234</companynumb>
    <primarysource>
      <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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIRSUTISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIUMBILICAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAFERON (INTERFERON BETA - 1B) INJECTION, 250UG</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2 D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532207-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004084839</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugauthorizationnumb>21134</drugauthorizationnumb>
        <drugdosagetext>15 MG (15 MG, 1 IN 1 D), TRANSDERMAL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugdosagetext>80 MG (40 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG (50 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>120 MG (120 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOMYOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID (ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN ASPART (INSULIN ASPART)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532208-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041205</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104062</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>50710</drugauthorizationnumb>
        <drugdosagetext>10 MCG/KG (10 MG/KG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532209-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004107045</companynumb>
    <primarysource>
      <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>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>21266</drugauthorizationnumb>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532210-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106425</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>75 MG (25 MG, 3 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>(4 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHLEBOTHROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532211-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TNZFR200400132</companynumb>
    <primarysource>
      <qualification>1</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INNOHEP</medicinalproduct>
        <drugauthorizationnumb>20484</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>PHLEBITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532212-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CERZ-10731</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-UTERINE DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>20367</drugauthorizationnumb>
        <drugdosagetext>3600 UNITS Q2WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532213-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030904</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20030603932</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERMOX</medicinalproduct>
        <drugauthorizationnumb>17481</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STRONGYLOIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERMOX</medicinalproduct>
        <drugauthorizationnumb>17481</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STRONGYLOIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERMOX</medicinalproduct>
        <drugauthorizationnumb>17481</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STRONGYLOIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030520</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532215-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106458</companynumb>
    <primarysource>
      <qualification>1</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKULL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>20753</drugauthorizationnumb>
        <drugdosagetext>25 MG (DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER FEMALE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL (BISOPROLOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID (ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIOCTIC ACID (THIOCTIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532216-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EMR64300001-13</companynumb>
    <primarysource>
      <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>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
        <drugdosagetext>1500 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040919</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532217-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004101165</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BACTERIAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugauthorizationnumb>9987</drugauthorizationnumb>
        <drugdosagetext>5 MG (5 MG, DAILY INTERVAL:  EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIXED CONNECTIVE TISSUE DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>(10 MG, WEEKLY INTERVAL:  EVERY WEEK), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIXED CONNECTIVE TISSUE DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532218-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004100018</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASPIRATION BRONCHIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDURA XL</medicinalproduct>
        <drugauthorizationnumb>19668</drugauthorizationnumb>
        <drugdosagetext>4 MG (4 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532219-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040816</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04KOR0192</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRASTAT</medicinalproduct>
        <drugauthorizationnumb>20913</drugauthorizationnumb>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRASAT (TIROFIBAN HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>7 ML/HR, INJECTION</drugdosagetext>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532220-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040816</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04KOR0191</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRASTAT</medicinalproduct>
        <drugauthorizationnumb>20913</drugauthorizationnumb>
        <drugdosagetext>INJECTION</drugdosagetext>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRASTAT</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADROPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532221-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-10-0038</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAFERONPEG</medicinalproduct>
        <drugdosagetext>120 MCG SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>1000 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>400 MG TID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENCEPHALOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>3 DOSES BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>150 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBUTEX</medicinalproduct>
        <drugdosagetext>8 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG ABUSER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532222-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0076</companynumb>
    <primarysource>
      <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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM PQ INTERVAL PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugauthorizationnumb>21165</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532223-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-10-1524</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
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        <drugstartdate>20030623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031211</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>6 MIU TIW INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL (BENIDIPINE HCL) TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEBERA G STRONG INJ. INJECTABLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRONGER NEO MINOPHAGEN C INJECTABLE 2A</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRONGER NEO MINOPHAGEN C INJECTABLE 3A</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRONGER NEO MINOPHAGEN C INJECTABLE 4A</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPOVAS TABLETS</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM TABLETS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>..</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532224-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MEDI-0002533(0)</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>4.82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUDDEN INFANT DEATH SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugdosagetext>72 MG, 1 IN 30 D, INTRAMUSCULAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYRON (SODIUM FEREDETATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABIDEC (ERGOCALCIFEROL, ASCORBIC ACID, THIAMINE HYDROCHLORIDE, RETINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532225-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_25472_2004</companynumb>
    <primarysource>
      <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>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugauthorizationnumb>17794</drugauthorizationnumb>
        <drugdosagetext>8 MG ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEER</medicinalproduct>
        <drugdosagetext>2 BOTTLE ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPARKLING WINE</medicinalproduct>
        <drugdosagetext>0.5 L ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041128</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532226-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DSA_25478_2004</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMESTA</medicinalproduct>
        <drugauthorizationnumb>17794</drugauthorizationnumb>
        <drugdosagetext>0.5 MG Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19730101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTACAND</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532227-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE04292</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS TOXIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AXAGON</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugdosagetext>80 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIATUS HERNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040702</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532228-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP05754</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCLOXACILLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040309</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532229-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040910</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE04310</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugdosagetext>40 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040711</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HELICLAR</medicinalproduct>
        <drugdosagetext>40 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040711</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLEMOXIN</medicinalproduct>
        <drugdosagetext>40 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040711</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORMONOCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532230-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02050</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugdosagetext>40 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
        <drugdosagetext>40 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugdosagetext>10 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532231-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004CG02289</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
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        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040920</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
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        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOPRAL</medicinalproduct>
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        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>6 G DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040922</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIFLOX</medicinalproduct>
        <drugdosagetext>800 MG DAILY IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AXEPIM</medicinalproduct>
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        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYPNOVEL</medicinalproduct>
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        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
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        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCOMYST</medicinalproduct>
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        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIMBEX</medicinalproduct>
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        <drugstartdate>20040925</drugstartdate>
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        <drugenddate>20041001</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532232-6</safetyreportid>
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    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004SE06211</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBRA</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTESIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532233-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004PK01195</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS TOXIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugdosagetext>20 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532234-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-0007823</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <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>VIREAD</medicinalproduct>
        <drugauthorizationnumb>21356</drugauthorizationnumb>
        <drugdosagetext>300 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>250 MG, 1 IN 1D</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NELFINAVIR (NELFINAVIR)</medicinalproduct>
        <drugdosagetext>2.5 GM, 1 IN 1 D</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>6 MG, 1 IN 1 D</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugdosagetext>250 MG, 1 IN 1 D</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040506</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532235-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>206833</companynumb>
    <primarysource>
      <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>GLOMERULONEPHRITIS PROLIFERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS NEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; QW; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532236-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978534</companynumb>
    <primarysource>
      <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>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532237-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978573</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJACULATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALE ORGASMIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7S697W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GALENIC /MISOPROSTOL/DICLOFENAC  SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532238-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>K200401860</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE ROLLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIGAN</medicinalproduct>
        <drugauthorizationnumb>17529</drugauthorizationnumb>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO (ESCITALOPRAM OXALATE) 20 MG</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO (ESCITALOPRAM OXALATE) 20 MG</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO (ESCITALOPRAM OXALATE) 20 MG</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO (ESCITALOPRAM OXALATE) 20 MG</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE (TRAZODONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGEN NOS (ESTROGEN NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532239-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978586</companynumb>
    <primarysource>
      <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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532240-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>K200401877</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR TEXTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLORINEF</medicinalproduct>
        <drugauthorizationnumb>10060</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORTHOSTATIC HYPOTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLORINEF</medicinalproduct>
        <drugauthorizationnumb>10060</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORTHOSTATIC HYPOTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLORINEF</medicinalproduct>
        <drugauthorizationnumb>10060</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORTHOSTATIC HYPOTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN ^LAPPE^ (VITAMINS NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532241-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978592</companynumb>
    <primarysource>
      <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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532242-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ABBOTT-04P-083-0283803-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANDOLAPRIL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532243-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>206349</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>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>300 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CPT-11 (IRINOTECAN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532245-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ABBOTT-04P-083-0283801-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532246-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0283104-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKINE CHRONO TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532247-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-04P-020-0276716-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOPTEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOPTEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBOMET</medicinalproduct>
        <drugdosagetext>500 MG GLIABENCLAMIDE/2.5 MG METFORMIN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>7.5 MG DAILY WAS PRESCRIBED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMALGIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532248-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>205810</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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040327</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532249-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ABBOTT-04P-151-0282914-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOACTIVE DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532251-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ABBOTT-04P-083-0283994-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NODAL RHYTHM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINOATRIAL BLOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANDOLAPRIL/VERAPAMIL SR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>2MG/180MG</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532252-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>210829</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>5 MG/KF, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE, TRIAMTERENE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON (IRON NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532253-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0276498-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPANTHYL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532254-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978614</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00S</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG IN THE MORNING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNITHROID (LEVOTHYROXINE SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIOTHYRONINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532255-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-04P-087-0283638-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITH</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040712</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040712</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040712</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532256-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-ABBOTT-04P-078-0282964-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEAFNESS BILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE SUPRANUCLEAR PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532257-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>208300</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.6</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>270 MG, Q2W, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL INTESTINE CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040624</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOXI (PALONOSETRON)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532258-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-04P-062-0283047-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>803</patientonsetageunit>
      <patientweight>3.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICHOLINERGIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELAYED RECOVERY FROM ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE (SEVOFLURANE LIQUID FOR INHALATION)</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1.5 MINIMUM ALVEOLAR CONCENTRATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>2.5% GLUCOSE IN RINGER'S SOLUTION</medicinalproduct>
        <drugdosagetext>40 MILLILITERS PER HOUR</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugdosagetext>0.03 MILLIGRAMS</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOHEXITAL</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>4532259-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978622</companynumb>
    <primarysource></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>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG43S</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE W/ IRBESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS CONJUGATED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532260-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040903</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-04P-028-0272719-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVAL TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVAL TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVAL TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
        <drugtreatmentduration>786</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR SOFT GELATIN CAPSULES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021211</drugenddate>
        <drugtreatmentduration>786</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIPRANAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
        <drugtreatmentduration>787</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCYCLIDINE HYDROCHLORIDE 2MG TAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
        <drugtreatmentduration>151</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOMANIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HYPOMANIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040716</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
        <drugtreatmentduration>642</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
        <drugtreatmentduration>642</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
        <drugtreatmentduration>128</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
        <drugtreatmentduration>128</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
        <drugtreatmentduration>128</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
        <drugtreatmentduration>128</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATOVAQUONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
        <drugtreatmentduration>154</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATOVAQUONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040912</drugenddate>
        <drugtreatmentduration>154</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040912</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGIC MOUTHWASH</medicinalproduct>
        <drugindication>ORAL CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040912</drugenddate>
        <drugtreatmentduration>204</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19921201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040912</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGAVIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE (T-20)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE (T-20)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISACODYL</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISACODYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHORAL HYDRATE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
        <drugtreatmentduration>209</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugindication>HYPOMANIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532261-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>173284</companynumb>
    <primarysource>
      <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>LUMBAR RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FUSION SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P01042</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532262-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040923</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0274774-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REACTION TO DRUG EXCIPIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZECLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19910101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZECLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532263-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0281441-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</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 BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPANTHYL TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
        <drugtreatmentduration>176</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOSULEPIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFLOMEDIL HYDROCHLORIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
        <drugtreatmentduration>421</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUINDIONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUINDIONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYAMEMAZINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040813</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532264-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978646</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>105</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXCITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>CT508001</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532266-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415883BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.4108</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>2927340</drugbatchnumb>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>660 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532267-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080119</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SCROTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY HESITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532268-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413453BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>9313Y</drugbatchnumb>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIGH BLOOD PRESSURE PILLS (NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KCL TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532269-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080122</companynumb>
    <primarysource>
      <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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532270-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421173BWH</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>20304</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532271-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080127</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532272-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>235964K04USA</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532273-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080128</companynumb>
    <primarysource>
      <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>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532274-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080131</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532275-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200406403</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRED FORTE</medicinalproduct>
        <drugauthorizationnumb>17011</drugauthorizationnumb>
        <drugdosagetext>1 DROP QID EYE</drugdosagetext>
        <drugindication>POSTOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACULAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532276-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080135</companynumb>
    <primarysource>
      <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>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/DAILY IN THE EVENING</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532277-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080140</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532278-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200406402</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACULAR</medicinalproduct>
        <drugauthorizationnumb>19700</drugauthorizationnumb>
        <drugdosagetext>1 DROP QID EYE</drugdosagetext>
        <drugindication>POSTOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRED FORTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532279-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080142</companynumb>
    <primarysource>
      <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532280-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080145</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532281-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1000206</companynumb>
    <primarysource>
      <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>TRANSMISSION OF DRUG VIA SEMEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORIATANE</medicinalproduct>
        <drugauthorizationnumb>19821</drugauthorizationnumb>
        <drugdosagetext>VAG</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532282-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080159</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/ 1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532283-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04H-163-0281458-00</companynumb>
    <primarysource>
      <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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISINHIBITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRECEDEX</medicinalproduct>
        <drugbatchnumb>00000 DK</drugbatchnumb>
        <drugauthorizationnumb>21038</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532284-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200412103BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIMITOCHONDRIAL ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS A ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOSPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS SEASONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSFERRIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>440 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC EFFECT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLEGRA-D</medicinalproduct>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532285-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000881</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</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>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>
      </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>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532286-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000793</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE GRAFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532287-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000798</companynumb>
    <primarysource></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>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; Q5D; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>30 UG; Q5D; IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532288-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004BI000715</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>122.4712</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SUDDEN CARDIAC DEATH</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>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532289-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415987BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.8957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC EFFECT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532290-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415888BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>220 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETIC PILL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532291-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200415887BCC</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugbatchnumb>289394E</drugbatchnumb>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>200 MG, ONCE, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532292-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004094016</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.8122</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugauthorizationnumb>12151</drugauthorizationnumb>
        <drugdosagetext>25 MG (25 MG, EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532293-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410106975</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG87W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>POSTPARTUM DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532294-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004242238US</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG (10 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532295-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410106992</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532296-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104944</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (100 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN (TELMISARTAN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532297-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410107077</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040904</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532298-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108830</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19700101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532299-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410107154</companynumb>
    <primarysource>
      <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 PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532300-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004236760US</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532301-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410107155</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERCHLORHYDRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532302-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108604</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532303-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410107169</companynumb>
    <primarysource>
      <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>HOARSENESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG39P</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532304-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004109105</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532305-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410107225</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532306-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004109258</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532307-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410107299</companynumb>
    <primarysource>
      <qualification>1</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>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532308-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410107309</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANORGASMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJACULATION FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532309-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004110061</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532310-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0410107314</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532311-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004109622</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532312-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004110098</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532313-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004239035US</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108.8633</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>200 MG (200 MG, 1 IN 1 D)</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532314-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080244</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532315-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108068</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.5234</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLTERODINE LA (TOLTERODINE)</medicinalproduct>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>4 MG (4 MG, EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532316-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979687</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532317-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108107</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DRAINAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>21228</drugauthorizationnumb>
        <drugdosagetext>4 MG (2 MG, DAILY INTERVAL:  EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INCONTINENCE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE (ESOMEPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES (ANTIHYPERTENSIVES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM (MONTELUKAST SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE MITE (FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532318-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979477</companynumb>
    <primarysource>
      <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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532319-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108576</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATEST H.S.</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532320-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979384</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532321-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-029558</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532322-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040924</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979215</companynumb>
    <primarysource>
      <qualification>1</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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBYAX</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532323-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-030027</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTED SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>8 MIU, EVERY 2D, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532324-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979147</companynumb>
    <primarysource>
      <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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532325-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979092</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532326-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004083497</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.9978</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECONOMIC PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>200 MG (100 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>200 MG (100 MG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532327-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978238</companynumb>
    <primarysource>
      <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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURINETHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532328-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004073145</companynumb>
    <primarysource>
      <qualification>3</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>ANTICONVULSANT DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>8762</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>8762</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>8762</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZTROPINE MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROPOIETIN (ERYTHROPOIETIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN (TERAZOSIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE (QUETIAPINE FUMARATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532329-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978227</companynumb>
    <primarysource>
      <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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532330-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004096293</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>(1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEMORY IMPAIRMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532331-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977344</companynumb>
    <primarysource>
      <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>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532332-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004090133</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.2554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF EMPLOYMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</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>NARDIL</medicinalproduct>
        <drugauthorizationnumb>11909</drugauthorizationnumb>
        <drugdosagetext>45 MG (15 MG), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532333-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106280</companynumb>
    <primarysource>
      <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>BLADDER CANCER RECURRENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugauthorizationnumb>19885</drugauthorizationnumb>
        <drugdosagetext>40 MG (40 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532334-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0411107555</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532335-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0411107640</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/2 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532336-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004047431</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.5234</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ELECTROLYTES DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN EXACERBATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMYALGIA RHEUMATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
        <drugauthorizationnumb>20931</drugauthorizationnumb>
        <drugdosagetext>1000 MCG (500 MCG, 2 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>20 MG (20 MG, QD INTERVAL: EVERY DAY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE (HYDROCODONE)</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN (WARFARIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE (HYDROCODONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (VITAMINS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532337-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0411107671</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532338-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108910</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <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>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532339-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0411107678</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532340-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004094822</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.8946</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC BYPASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUNBURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXAQUIN</medicinalproduct>
        <drugauthorizationnumb>20013</drugauthorizationnumb>
        <drugdosagetext>400 MG (400 MG, DAILY), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM PHOSPHATE MONOBASIC (POTASSIUM PHOSPHATE MONOBASIC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CITRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532341-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0411107684</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532342-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004107903</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532343-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0411107704</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532344-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041205</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004007070</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FIGHT IN SCHOOL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEGAL PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MURDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>200 MG (2 IN 1 D)</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532345-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0411107770</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532346-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106761</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.2554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYANOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAINFUL ERECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>(100 MG, AS NECESSARY) ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPROSTADIL</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENTOLAMINE (PHENTOLAMINE)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAPAVERINE (PAPAVERINE)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL HYDROCHLORIDE (VARDENAFIL HYDROCHLORIDE)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TADALAFIL (TADALAFIL)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532347-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0411107780</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>168</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRO (GLYCERYL TRINITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BABY ASPIRIN (ACETYSALICYLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROXATRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>..</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532348-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108693</companynumb>
    <primarysource></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>20702</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532349-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0411107790</companynumb>
    <primarysource>
      <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>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532350-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004108160</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>STOOL ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC-D 12 HOUR</medicinalproduct>
        <drugauthorizationnumb>21150</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532351-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004104252</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CLONIC CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WORD SALAD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>300 MG (300 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>300 MG (300 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHADONE (METHADONE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN (ATORVASTATIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB (CELECOXIB)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532352-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106658</companynumb>
    <primarysource></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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>NECK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532353-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004106719</companynumb>
    <primarysource></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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021116</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532354-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004109219</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532355-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004109202</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532356-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0412USA02056</companynumb>
    <primarysource>
      <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>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONES (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532357-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004109947</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532358-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00696</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLEPHARITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIDEPRESSANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532359-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00771</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>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532360-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-MERCK-0412SWE00025</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532361-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004109948</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532362-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA02014</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532363-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-MERCK-0412SWE00024</companynumb>
    <primarysource>
      <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>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020707</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>816</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532364-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-MERCK-0412SWE00026</companynumb>
    <primarysource>
      <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>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040414</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532365-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004109953</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14(ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532366-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0310FRA00043</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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    <patient>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugauthorizationnumb>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532379-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004109197</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532380-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-MERCK-0412SWE00029</companynumb>
    <primarysource>
      <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>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>1370</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532381-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041205</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004107069</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>21266</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532382-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01336</companynumb>
    <primarysource>
      <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>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532383-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01382</companynumb>
    <primarysource>
      <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>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532384-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01340</companynumb>
    <primarysource>
      <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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532385-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01379</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532386-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>A400803002/AKO-4674-AE</companynumb>
    <primarysource>
      <qualification>5</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>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugauthorizationnumb>16619</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532387-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2004-0017980</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugauthorizationnumb>19516</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXICODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL (RISEDRONATE SODIUM0</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532388-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0412AUS00061</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532389-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01378</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532390-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KII-2004-0014246</companynumb>
    <primarysource>
      <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>BLOOD PH INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED BRONCHIAL SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL EXAMINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULOCEPHALOGYRIC REFLEX ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILLARY REFLEX IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugdosagetext>SEE TEXT, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINE DERIVATES</medicinalproduct>
        <drugdosagetext>SEE TEXT, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532391-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01602</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532392-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01614</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532393-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>21435</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.9874</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
        <drugdosagetext>500 MG QHS PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS/USA/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532394-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01611</companynumb>
    <primarysource>
      <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>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532395-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01600</companynumb>
    <primarysource>
      <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>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532396-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01582</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532397-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004239035US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532398-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01375</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532399-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00219</companynumb>
    <primarysource>
      <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>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM Q WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532400-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01634</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532401-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041004964</companynumb>
    <primarysource>
      <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>BREAST MICROCALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL ARTHRITIS PAIN ER (ACETAMINOPHEN)</medicinalproduct>
        <drugbatchnumb>FMM112</drugbatchnumb>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
        <drugdosagetext>MAXIMUM 1300 MG DAILY, ^OFF AND ON^  ALL SUMMER</drugdosagetext>
        <drugindication>TENDONITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLORAZEPAM (CLORAZEPATE DIPOTASSIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL (ENALPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532402-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01627</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532403-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>USA-2004-0017953</companynumb>
    <primarysource>
      <qualification>1</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>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPECTRACEF</medicinalproduct>
        <drugauthorizationnumb>21222</drugauthorizationnumb>
        <drugdosagetext>400 MG , BID</drugdosagetext>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532404-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01626</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SICK SINUS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532405-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105299</companynumb>
    <primarysource></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>11839</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVELLA-14 (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE)</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532406-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-026874</companynumb>
    <primarysource>
      <qualification>1</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>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>QOD, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532407-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-036360</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532408-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12923</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INJECTION SITE EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISUDYNE</medicinalproduct>
        <drugauthorizationnumb>21119</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532409-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01613</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532410-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01705</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532411-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01698</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532412-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE717401DEC04</companynumb>
    <primarysource></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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGGRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL SELF-INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532413-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01802</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532414-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01759</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532415-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01697</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532416-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01821</companynumb>
    <primarysource>
      <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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532417-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE771906DEC04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BOWEL SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugauthorizationnumb>50684</drugauthorizationnumb>
        <drugdosagetext>3.375 G EVERY 6 HOURS, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABDOMINAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DROPERIDOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532418-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01700</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532419-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01860</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532420-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HQWYE615326AUG04</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugauthorizationnumb>50684</drugauthorizationnumb>
        <drugdosagetext>ONE DOSE AT 3.375 G, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABDOMINAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTATED RINGER'S (CALCIUM CHLORIDE DIHYDRATE/POTASSIUM CHLORIDE/SODIU</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESFLURANE (DESFLURANE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INAPSINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOSTIGMINE (NEOSTIGMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMENTIN (CLAVULANIC ACID/TICARCILLIN DISODIUM)PEPCID (FAMOTIDINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOSTIGMINE (NEOSTIGMINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCOPYRRONIUM BROMIDE (GLYCOPYRRONIUM BROMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN (CLINDAMYCIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOXITIN (CEFOXITIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOMIDATE (ETOMIDATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMBEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEMURON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESFLURANE (DESFLURANE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct> DEXTROSE AND SODIUM CHLORIDE (GLUCOSE /SODIUM CHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532421-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-2004-036399</companynumb>
    <primarysource>
      <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>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>UNSPECIFIED, SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532422-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>207509</companynumb>
    <primarysource>
      <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>ARTHRITIS INFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARTILAGE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532423-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413377GDS</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE MB INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC PRODUCT INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN I INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR GRAFT OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, TOTAL DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>3-HYDROXY-3-METHYLGLUTARYL COENZYME A (HMG-COA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANGIOTENSIN-CONVERTING ENZYME INHIBITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532424-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01919</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532425-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01757</companynumb>
    <primarysource>
      <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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532426-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-12-0492</companynumb>
    <primarysource>
      <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>BONE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>100 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIMMUNE (INTERFERON GAMMA-1B) INJECTABLE SOLUTION</medicinalproduct>
        <drugdosagetext>50 UG TIW</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFERAX (INTERFERON ALFACON-1) INJECTABLE SOLUTION</medicinalproduct>
        <drugdosagetext>17 UG  QD</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532427-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01917</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532428-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040312</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0403USA01342</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010321</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBETA (DIPIVEFRIN HYDROCHLORIDE (+) LEVOBUNOLOL HYDROCHLORIDE)</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532429-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01806</companynumb>
    <primarysource>
      <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020710</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532430-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01976</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532431-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-0913</companynumb>
    <primarysource>
      <qualification>1</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>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>120 MCG QWK SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHRONIC HEPATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>120 MCG QWK SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CRYOGLOBULINS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>1000 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC HEPATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>1000 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CRYOGLOBULINS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532432-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01948</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532433-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA02040</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532434-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01990</companynumb>
    <primarysource>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532435-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
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    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01941</companynumb>
    <primarysource>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532436-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-00453</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>169.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.3 MG BIW, IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN (OXYCODONNE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532437-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030113</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0301USA01106</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>105</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER NECK SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETHRAL STRICTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020824</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BURSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020824</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532438-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-00891</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE (THALIDOMIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532439-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>S04-USA-07777-01</companynumb>
    <primarysource>
      <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 TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532440-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20011025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-01104511</companynumb>
    <primarysource>
      <qualification>1</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>ACUTE SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGLE CLOSURE GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000420</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000823</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000420</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000823</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19760101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532441-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00654</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPOD STING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001030</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001030</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532442-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0301USA03184</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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESSENTIAL TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOEXFOLIATION OF LENS CAPSULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATIC FEVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS STASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CYSTITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MUSCLE CRAMP</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011023</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532443-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04120402</companynumb>
    <primarysource>
      <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>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532444-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>163-20785-04120331</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MG, DAILY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040908</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532445-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01966</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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532446-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>15640</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.3284</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>50731</drugauthorizationnumb>
        <drugdosagetext>45 MG/M2 OTHER</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532447-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0304USA00746</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST WALL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOCHROMATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIRSUTISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTOSE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-CARDIAC CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN STRIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT LOSS POOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIMICROBIAL (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESIC OR ANESTHETIC (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUTALBITAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532448-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004UW24064</companynumb>
    <primarysource>
      <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 CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>5 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVPAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532449-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040219</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0402USA01452</companynumb>
    <primarysource>
      <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>ACUTE SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS EROSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMATOSIS CYSTOIDES INTESTINALIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021114</drugenddate>
        <drugtreatmentduration>1218</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROPIPATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031114</drugenddate>
        <drugtreatmentduration>3956</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRIXORAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</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>MAGNESIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRIXORAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532450-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0304USA00834</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>111</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY RESTENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010401</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010801</drugenddate>
        <drugtreatmentduration>146</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010401</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010801</drugenddate>
        <drugtreatmentduration>146</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031210</drugenddate>
        <drugtreatmentduration>2170</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031210</drugenddate>
        <drugtreatmentduration>2170</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEART RATE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRONASE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031210</drugenddate>
        <drugtreatmentduration>1051</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532452-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>1668</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STUPOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVINZA</medicinalproduct>
        <drugauthorizationnumb>21260</drugauthorizationnumb>
        <drugdosagetext>30 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVINZA</medicinalproduct>
        <drugdosagetext>90 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVINZA</medicinalproduct>
        <drugdosagetext>30 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532453-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040617</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0406USA01754</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIPATCH</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010518</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532454-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00636</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
        <drugtreatmentduration>479</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM ASPARTATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532455-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978848</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00Z</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOCYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532456-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040401</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0404USA00094</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020316</drugenddate>
        <drugtreatmentduration>223</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN-D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EX-SMOKER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORFLEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORFLEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532457-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978888</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EJACULATION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532458-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978891</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>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532459-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978893</companynumb>
    <primarysource>
      <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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532460-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978895</companynumb>
    <primarysource>
      <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>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532461-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00394</companynumb>
    <primarysource>
      <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>LOCALISED OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532462-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0412AUS00054</companynumb>
    <primarysource>
      <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>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532463-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA02784</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
        <drugtreatmentduration>1542</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532464-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978897</companynumb>
    <primarysource>
      <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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532465-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978902</companynumb>
    <primarysource>
      <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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/TWICE DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532466-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00809</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532467-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA02511</companynumb>
    <primarysource>
      <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>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532468-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LB-MERCK-0412USA01264</companynumb>
    <primarysource>
      <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>PRIMAXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532469-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00530</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532470-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0412AUS00055</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532471-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00115</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031018</drugenddate>
        <drugtreatmentduration>412</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031018</drugenddate>
        <drugtreatmentduration>412</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THYROIDECTOMY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENSERAZIDE HYDROCHLORIDE AND LEVODOPA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532472-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03671</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020924</drugstartdate>
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        <drugenddate>20021229</drugenddate>
        <drugtreatmentduration>97</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532473-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-MERCK-0411CHE00029</companynumb>
    <primarysource>
      <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>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CERVICAL ROOT PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
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        <drugenddate>20041004</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>4532474-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978920</companynumb>
    <primarysource>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
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    </patient>
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  <safetyreport>
    <safetyreportid>4532475-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978921</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG99M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG IN THE MORNING</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN (GABAPENTIN PFIZER)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532476-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978935</companynumb>
    <primarysource>
      <qualification>1</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>NIGHTMARE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532477-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978738</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532478-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0412GBR00109</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532479-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978746</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532480-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-MERCK-0412POL00004</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>35</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>SYSTEMIC MYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532481-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-MERCK-0412CHE00014</companynumb>
    <primarysource>
      <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>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE REPAIR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532482-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00129</companynumb>
    <primarysource>
      <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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER LIMB FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532483-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-MERCK-0412KOR00010</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041209</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041209</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041209</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041209</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532484-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-MERCK-0412KOR00008</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041203</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041203</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPIN</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532485-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03328</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL SEROLOGY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532486-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978748</companynumb>
    <primarysource>
      <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>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE EJACULATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532487-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-MERCK-0412CHE00015</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532488-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0412AUS00058</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>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532489-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-MERCK-0412CHN00024</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532490-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978775</companynumb>
    <primarysource></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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG IN THE MORNING</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON (MIRTAZAPINE ORIFARM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532491-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01954</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532492-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040918</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978779</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532493-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978783</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532494-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978816</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINE ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532495-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978821</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG98P</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRCETTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532496-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03655</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>139</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030307</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030730</drugstartdate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030528</drugenddate>
        <drugtreatmentduration>255</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532497-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978825</companynumb>
    <primarysource></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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00Z</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG AT NOON</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR (MONTELUKAST)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532498-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978842</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG98P</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR (SIMVASTATIN RATIOPHARM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE (RAMIPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532499-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978721</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EARLY MORNING AWAKENING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>DD24251</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532500-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978725</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00Z</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532501-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978728</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 AT BEDTIME</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532502-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978658</companynumb>
    <primarysource>
      <qualification>3</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532503-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978675</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZADONE (TRAZODONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532504-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978686</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532505-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA02212</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>127</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC DISSECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532506-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978701</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>145</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THORAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532507-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978715</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00Z</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIGH BLOOD PRESSURE MEDICINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532508-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978716</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>114</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG40P</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>NEUROPATHIC PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN (NAPROXEN MEPHA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532509-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978717</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG98P</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERA-HS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532510-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082456</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugindication>MESOTHELIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC CID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532511-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081957</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD FOLATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD FOLATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532512-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082142</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugindication>MESOTHELIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN SUPPLEMENTATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532513-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081937</companynumb>
    <primarysource>
      <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>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE REDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENA CAVA THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN SUPPLEMENTATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532514-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081197</companynumb>
    <primarysource>
      <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>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugindication>MESOTHELIOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532515-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080630</companynumb>
    <primarysource>
      <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>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532516-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040924</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979179</companynumb>
    <primarysource>
      <qualification>1</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>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532517-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978486</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugbatchnumb>FF4C87D</drugbatchnumb>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>750 MG</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532518-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978651</companynumb>
    <primarysource>
      <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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2 OTHER</drugdosagetext>
        <drugindication>PERITONEAL MESOTHELIOMA MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532519-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040772098</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-SMALL CELL LUNG CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugbatchnumb>FF3P55D</drugbatchnumb>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>850 MG</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040708</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUSSIONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532520-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081395</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugindication>LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532521-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081716</companynumb>
    <primarysource>
      <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>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532522-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081738</companynumb>
    <primarysource>
      <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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugindication>MESOTHELIOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</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>CORTICOSTEROID NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532523-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081768</companynumb>
    <primarysource>
      <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>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN SUPPLEMENTATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532524-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081952</companynumb>
    <primarysource>
      <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>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532525-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082276</companynumb>
    <primarysource>
      <qualification>3</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>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532526-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082291</companynumb>
    <primarysource>
      <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>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>750 MG</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532527-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082668</companynumb>
    <primarysource>
      <qualification>1</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>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN SUPPLEMENTATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532528-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977245</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2</drugdosagetext>
        <drugindication>MESOTHELIOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</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>DECADRON (DEXAMETHASONE0</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532529-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977483</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH FOLLICULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532530-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979042</companynumb>
    <primarysource>
      <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>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>750 MG/M2/1 OTHER</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532531-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979555</companynumb>
    <primarysource>
      <qualification>2</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>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532532-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979636</companynumb>
    <primarysource>
      <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>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugbatchnumb>SF4C87D</drugbatchnumb>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>1000 MG</drugdosagetext>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANZEMET (DOLASETRON MESILATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532533-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080437</companynumb>
    <primarysource>
      <qualification>3</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>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN SUPPLEMENTATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532534-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080838</companynumb>
    <primarysource>
      <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>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALAGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</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 B-12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532535-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081028</companynumb>
    <primarysource>
      <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>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>800 MG/M2 OTEHR</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugdosagetext>500 MG/M2 OTEHR</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532536-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081203</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>1000 MG</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </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>DECADRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532537-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081207</companynumb>
    <primarysource>
      <qualification>3</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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>925 MG OTHER</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </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>DECADRON (DEXAMETHASONE SODUJM PHOSPHATE0</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532538-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040805</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040566909</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532539-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040813</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040774145</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugbatchnumb>FF3P55D</drugbatchnumb>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2 OTHER</drugdosagetext>
        <drugindication>PLEURAL MESOTHELIOMA MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532540-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040806</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040874636</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</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>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugindication>MESOTHELIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040708</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIEMETIC</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 B12 FOR INJECTION (CYANOCOBALAMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXATIVE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532541-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040874806</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KERATOCONJUNCTIVITIS SICCA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>850 MG OTHER</drugdosagetext>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>850 MG OTHER</drugdosagetext>
        <drugindication>PLEURAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</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>TAXOTERE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532542-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040875027</companynumb>
    <primarysource>
      <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>SKIN HYPERPIGMENTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>740 MG OTHER</drugdosagetext>
        <drugindication>LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</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>4532543-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040813</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040875542</companynumb>
    <primarysource>
      <qualification>3</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>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532544-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876517</companynumb>
    <primarysource>
      <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>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2 OTHER</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>1000 MG/M2 OTHER</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532545-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876529</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>105</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</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>ALIMTA</medicinalproduct>
        <drugbatchnumb>FF4C87D</drugbatchnumb>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>1000 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZACITIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532546-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876560</companynumb>
    <primarysource>
      <qualification>3</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>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugdosagetext>830 MG OTHER</drugdosagetext>
        <drugindication>PLEURAL MESOTHELIOMA MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532547-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876952</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>21462</drugauthorizationnumb>
        <drugindication>MESOTHELIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532548-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004UW23974</companynumb>
    <primarysource></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>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532549-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004UW24408</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532550-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004UW19136</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532551-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040525</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>PHEH2004US05836</companynumb>
    <primarysource>
      <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 OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIVELLE</medicinalproduct>
        <drugauthorizationnumb>20323</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROPIPATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTROGENS (NO INGREDIENTS/SUBSTANCES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532552-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040715</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>PHEH2004US07657</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIVELLE</medicinalproduct>
        <drugauthorizationnumb>20323</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALORA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLIMARA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532553-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040715</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>PHEH2004US07662</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIVELLE</medicinalproduct>
        <drugauthorizationnumb>20323</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLIMARA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532554-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040715</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>PHEH2004US07663</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIVELLE (ESTRADIOL) MATRIX</medicinalproduct>
        <drugauthorizationnumb>20323</drugauthorizationnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532555-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040616</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>20040600323</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugauthorizationnumb>74496</drugauthorizationnumb>
        <drugdosagetext>2 MG ONCE IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG LEVEL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE (BRISTOL MYERS SQUIBB)</medicinalproduct>
        <drugdosagetext>15 MG IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG LEVEL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugdosagetext>15 MG IM</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DRUG LEVEL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040527</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532556-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979614</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532557-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979624</companynumb>
    <primarysource>
      <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>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532558-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979639</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 EVERY OTHER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532559-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979650</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532560-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979659</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532561-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979662</companynumb>
    <primarysource>
      <qualification>3</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>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG99M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532562-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979680</companynumb>
    <primarysource>
      <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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INDIFFERENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532563-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979682</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532564-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979688</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040918</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532565-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979696</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR (SIMVASTATIN RATIOPHARM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532566-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979532</companynumb>
    <primarysource>
      <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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532567-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979540</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532568-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979541</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZADONE (TRAZODONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MED</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532569-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979542</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532570-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979550</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532571-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979562</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97P</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532572-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979578</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532573-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979584</companynumb>
    <primarysource>
      <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>MUSCLE CONTRACTIONS INVOLUNTARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532574-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979585</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACRODANTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532575-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979612</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUTANE (ISOTRETINOIN RATIOPHARM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532576-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041079880</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MGDAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532577-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041079886</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG98P</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532578-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041079890</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG96R</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532579-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041079893</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG96R</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532580-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041079896</companynumb>
    <primarysource>
      <qualification>3</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>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG96R</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532581-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041079898</companynumb>
    <primarysource>
      <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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLAT AFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN EXACERBATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532582-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040924</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041079901</companynumb>
    <primarysource>
      <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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040902</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532583-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041079902</companynumb>
    <primarysource>
      <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>CHILLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532584-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041079905</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</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>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60 MG/ 1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TALACEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532585-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041079915</companynumb>
    <primarysource>
      <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>CYSTITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00Z</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532618-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.8435</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>INTRACARDIAC THROMBUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532621-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.8539</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUMEGA</medicinalproduct>
        <drugdosagetext>ONLY ONE DOSE , SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUMEGA</medicinalproduct>
        <drugdosagetext>ONLY ONE DOSE , SC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532622-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugindication>ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532623-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>107.0489</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25 MG ONE QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532624-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL EXUDATES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG INTERFERON ALFA 2A</medicinalproduct>
        <drugdosagetext>180 MCG SC WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532626-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSPASM CORONARY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>1-2 PER DAY DAILEY</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>1-2 PER DAY DAILEY</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532627-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.1428</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE (GENERIC)</medicinalproduct>
        <drugdosagetext>20 MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532628-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041217</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.1834</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1Q 1 DAY</drugdosagetext>
        <drugindication>BLOOD GLUCOSE INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532629-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.2043</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>1 MG PO QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>1 MG PO QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532630-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.978</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>250 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIVERT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRO-K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532636-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugdosagetext>SQ Q  2 WKS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532637-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</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>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG PO QD X 3 DOSES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APAP TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532638-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.8748</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>2 PO TID PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532639-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.9671</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>474 MG / IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>474 MG / IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532640-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.6683</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>375 MG/M2 (600 MG) IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOP CHEMOTHERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532641-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1 GRAM EVERY 72 HOURS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOCARDITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1 GRAM EVERY 72 HOURS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAMPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532642-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-0930</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugdosagetext>DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINALPRODUCT NOT SPECIFIED BY SENDER</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532643-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-0936</companynumb>
    <primarysource>
      <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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugdosagetext>DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG ABUSER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIANSERIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532644-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16713</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEFFIX</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532645-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16719</companynumb>
    <primarysource>
      <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>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>40 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532646-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16861</companynumb>
    <primarysource>
      <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>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532647-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2004AU01703</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>0.83 MG, ONCE/SINGLE</drugdosagetext>
        <drugindication>MULTIPLE FRACTURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRMATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTA-VITE CHILDRENS VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTELIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532648-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004JP17321</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAONIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532649-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13307</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532650-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CA15862</companynumb>
    <primarysource>
      <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>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN BREAST NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIAL ABLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADOT</medicinalproduct>
        <drugdosagetext>50 UG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADERM</medicinalproduct>
        <drugdosagetext>50 UG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532651-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004DE17015</companynumb>
    <primarysource>
      <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>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIGANTOLETTEN ^BAYER^</medicinalproduct>
        <drugdosagetext>500 IU, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONATE</medicinalproduct>
        <drugdosagetext>4 MG QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040315</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532652-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE04120</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADOT</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HYSTERECTOMY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532654-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004US00641</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>185</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</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 UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC VARICES HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OGEN</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>VARICES OESOPHAGEAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>FLUID RETENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040110</drugenddate>
        <drugtreatmentduration>346</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040110</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>HEPATIC STEATOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040110</drugenddate>
        <drugtreatmentduration>151</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>MUSCLE CRAMP</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040110</drugenddate>
        <drugtreatmentduration>167</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DIABETIC RETINOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031209</drugenddate>
        <drugtreatmentduration>616</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532656-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP14746</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC AGENT TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugdosagetext>60 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPROMEL</medicinalproduct>
        <drugdosagetext>50 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030914</drugenddate>
        <drugtreatmentduration>640</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRAMIDE</medicinalproduct>
        <drugdosagetext>30 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
        <drugtreatmentduration>627</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTAN</medicinalproduct>
        <drugdosagetext>15 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
        <drugtreatmentduration>627</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugdosagetext>0.5 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILECE</medicinalproduct>
        <drugdosagetext>4 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A</medicinalproduct>
        <drugdosagetext>1 DF/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011214</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532658-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040715</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE02527</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICELLA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DERMATITIS ATOPIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMOLLIENTS AND PROTECTIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532659-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040917</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004NZ13155</companynumb>
    <primarysource>
      <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>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLORECTAL CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
        <drugtreatmentduration>3796</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532660-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12338</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTOSE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIFE SUPPORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ZINC DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugindication>RASH GENERALISED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RASH GENERALISED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532661-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004DE17395</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTENSOR PLANTAR RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRABISMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FTY720 VS MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
        <drugtreatmentduration>143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>175 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
        <drugtreatmentduration>143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugdosagetext>15 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532662-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041127</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004IT16923</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>50 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>125 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040828</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532663-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004JP17930</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-ABDOMINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC EMBOLISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>200 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>APLASTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030714</drugenddate>
        <drugtreatmentduration>36000</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>150 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030803</drugenddate>
        <drugtreatmentduration>28800</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>50 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030901</drugenddate>
        <drugtreatmentduration>41760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>50 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031215</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>100 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040822</drugenddate>
        <drugtreatmentduration>251</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>50 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
        <drugtreatmentduration>94</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTROGIN</medicinalproduct>
        <drugindication>APLASTIC ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-LOTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HANP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532664-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13049</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN LA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532665-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040305</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR01068</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>145</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NATRIURETIC PEPTIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAREG</medicinalproduct>
        <drugdosagetext>160 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRETERAX</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VACCINES</medicinalproduct>
        <drugdosagetext>1 DF, QMO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>LEPTOSPIROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031127</drugenddate>
        <drugtreatmentduration>46080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELESTENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031203</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031203</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PNEUMOREL</medicinalproduct>
        <drugindication>BRONCHITIS ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031203</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIMETAPP</medicinalproduct>
        <drugindication>BRONCHITIS ACUTE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
        <drugindication>BRONCHITIS ACUTE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532666-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040226</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004NZ02938</companynumb>
    <primarysource>
      <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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOGORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOID PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESSURE OF SPEECH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO OR VALSARTAN</medicinalproduct>
        <drugdosagetext>LEVEL 1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEO-NACLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUANXOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLACKMORES HIGH-POTENCY B PLUS C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATEGLINIDE VS PLACEBO</medicinalproduct>
        <drugdosagetext>LEVEL 1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLUCOSE TOLERANCE IMPAIRED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMAC</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENIUM TRACE METAL ADDITIVE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532667-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>210 MG IV X 1 DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>210 MG IV X 1 DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>210 MG IV X 1 DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugdosagetext>5000 MG IV QD X 3 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugdosagetext>5000 MG IV QD X 3 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugdosagetext>5000 MG IV QD X 3 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532668-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03639</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugindication>BLEPHAROSPASM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532669-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-NOVOPROD-241008</companynumb>
    <primarysource>
      <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>APATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR PENFILL</medicinalproduct>
        <drugdosagetext>28 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>40 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYBON</medicinalproduct>
        <drugdosagetext>2 UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVODIGAL</medicinalproduct>
        <drugdosagetext>1 UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMID ^DAK^</medicinalproduct>
        <drugdosagetext>1 UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532670-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-NOVOPROD-240733</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN DETEMIR</medicinalproduct>
        <drugdosagetext>36 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>58 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugdosagetext>UNK G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532671-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040818</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-238792</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>100 UG/KG, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEPATIC TRAUMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040810</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532672-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugdosagetext>150MG IN 310ML DSW</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031016</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532673-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040902</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BR11660</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMYOTROPHIC LATERAL SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER STAGE IV</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532674-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040820</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-NOVOPROD-238779</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugbatchnumb>NU60448</drugbatchnumb>
        <drugdosagetext>120 KIU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031007</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN</medicinalproduct>
        <drugbatchnumb>MU61207</drugbatchnumb>
        <drugdosagetext>360 KIU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031007</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANVITOFF</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031006</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANVITOFF</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031007</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HAEMOCOMPLETTAN HS</medicinalproduct>
        <drugdosagetext>3 G, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031007</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532675-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-240519</companynumb>
    <primarysource>
      <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 GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugbatchnumb>PW51036</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532676-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13189</companynumb>
    <primarysource>
      <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>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532677-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12524</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EDENTULOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENANTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEBRIDEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugindication>PROTEINURIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM /USA/</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>10 MG, PRN</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>0.5 MG, PRN</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, QD</drugdosagetext>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>50 MG, QHS</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>40 MG, QW</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugdosagetext>1 TAB/BID</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040827</drugenddate>
        <drugtreatmentduration>141</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>90 MG, QMO</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040312</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532678-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugdosagetext>200 MG IV QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL BACTERAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAFCILLIN</medicinalproduct>
        <drugdosagetext>2 GM IV Q 4 HR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL BACTERAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFAVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532679-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CA16657</companynumb>
    <primarysource>
      <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>COLOUR VISION TESTS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KERATOCONJUNCTIVITIS SICCA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUNCTATE KERATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL PIGMENT EPITHELIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SJOGREN'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEFEROXAMINE</medicinalproduct>
        <drugdosagetext>6 DAYS PER WEEK</drugdosagetext>
        <drugindication>BLOOD IRON INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEFEROXAMINE</medicinalproduct>
        <drugdosagetext>3 DAYS FOLLOWED BY 2 DAYS OF NO INTAKE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532680-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE04113</companynumb>
    <primarysource>
      <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>SANDOSTATIN LAR</medicinalproduct>
        <drugdosagetext>10 MG, QMO</drugdosagetext>
        <drugindication>ACROMEGALY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN</medicinalproduct>
        <drugindication>ACROMEGALY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532681-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13274</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARLODEL</medicinalproduct>
        <drugbatchnumb>127J2175</drugbatchnumb>
        <drugdosagetext>2.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPROLACTINAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532682-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03663</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAFLON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARLODEL</medicinalproduct>
        <drugdosagetext>1 DF/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040926</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532683-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BR15951</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAFLAM</medicinalproduct>
        <drugdosagetext>50 MG, Q12H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERCILON</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532684-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.5651</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>95 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>95 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>95 MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532685-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004ES16797</companynumb>
    <primarysource>
      <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>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040804</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532686-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03670</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBILEUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATHYMIL</medicinalproduct>
        <drugdosagetext>60 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URBANYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugdosagetext>7.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFADIN</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOCILLINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugdosagetext>30 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugdosagetext>60 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532687-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CR15756</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532688-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE03945</companynumb>
    <primarysource>
      <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>ECZEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINES FOR SYSTEMIC USE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
        <drugindication>DERMATITIS ATOPIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040310</drugenddate>
        <drugtreatmentduration>17280</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532689-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.9467</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugbatchnumb>LN C027748</drugbatchnumb>
        <drugdosagetext>1 GM IV Q 24HR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POSTOPERATIVE INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugbatchnumb>LN C027748</drugbatchnumb>
        <drugdosagetext>1 GM IV Q 24HR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POSTOPERATIVE INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041205</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532690-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13211</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR DAMAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIDEL</medicinalproduct>
        <drugdosagetext>1 %, PRN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532691-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2003JP14420</companynumb>
    <primarysource>
      <qualification>1</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>BLAST CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT 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>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030129</drugenddate>
        <drugtreatmentduration>31680</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030205</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>UNK, NO TREATMENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030226</drugenddate>
        <drugtreatmentduration>30240</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030312</drugenddate>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>UNK, NO TREATMENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030409</drugenddate>
        <drugtreatmentduration>40320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030423</drugenddate>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>UNK, NO TREATMENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030520</drugenddate>
        <drugtreatmentduration>38880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030617</drugenddate>
        <drugtreatmentduration>40320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030624</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030711</drugenddate>
        <drugtreatmentduration>24480</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030715</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040105</drugenddate>
        <drugtreatmentduration>174</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532692-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030611</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2003CZ07484</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030228</drugenddate>
        <drugtreatmentduration>123</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532693-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44.9061</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugdosagetext>1400</drugdosagetext>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>350</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041216</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532694-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004IN17608</companynumb>
    <primarysource>
      <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>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041203</drugenddate>
        <drugtreatmentduration>150</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532695-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BE16960</companynumb>
    <primarysource>
      <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>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISINHIBITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF MUTILATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041203</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532696-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13313</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532697-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03454</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
        <drugtreatmentduration>152</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532698-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.7298</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugdosagetext>300 MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>3TC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TDF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WB SR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532700-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTEPLASE 2 MG GENENTECH</medicinalproduct>
        <drugdosagetext>2 MG X 1</drugdosagetext>
        <drugindication>CATHETER RELATED COMPLICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041009</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532701-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAINFUL ERECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENILE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENIS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>50 MG 2 TAB DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532702-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041201333</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</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>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLAZONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532703-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041201685</companynumb>
    <primarysource>
      <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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS RETROBULBAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532704-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-JNJFOC-20041202125</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCUTANEOUS FISTULA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>ONE DAY.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>GASTROINTESTINAL ULCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532705-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041202552</companynumb>
    <primarysource>
      <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>NOCARDIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532706-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041202661</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532707-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20041202762</companynumb>
    <primarysource>
      <qualification>1</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>ANEURYSMECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTICOAGULANTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-TRIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NU-TRIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532708-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041202786</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RETINAL VEIN OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532710-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040606041</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <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>
      </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>AZATHIOPRINE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
        <drugdosagetext>TUESDAY AND THURSDAY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIVELLA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIVELLA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-HISTAMINE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-HISTAMINE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-HISTAMINE TAB</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532711-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20041106720</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>0.8ML</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532712-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20040201526</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATINE PHOSPHOKINASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIUM AVIUM COMPLEX INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOUS PLEURISY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3MG/KG</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3MG/KG</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3MG/KG</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMATIL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532713-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040802785</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</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>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTAS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532714-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041106081</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532715-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041103945</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERITONEAL TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25MG - 50MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532716-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20040800670</companynumb>
    <primarysource>
      <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>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>DURATION: 10 MONTHS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532717-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041000189</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</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>ARAVA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532718-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-JNJFOC-20041102759</companynumb>
    <primarysource>
      <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>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>THE PATIENT HAS RECEIVED A TOTAL OF 17 INFUSIONS.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532719-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20040905271</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>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSENTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL CONDITION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALMONELLA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3 DOSES RECEIVED.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532720-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20041104723</companynumb>
    <primarysource>
      <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>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LISTERIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERINFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532721-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20041106544</companynumb>
    <primarysource>
      <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>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACILLUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPYEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532722-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20040904286</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>27 INFUSION IN TOTAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DACORTIN</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532723-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20041100791</companynumb>
    <primarysource>
      <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>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532724-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040802658</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.25</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESSENTIAL TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</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>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYSET</medicinalproduct>
        <drugindication>BLOOD GLUCOSE FLUCTUATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
        <drugindication>TREMOR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030327</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532725-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 300</medicinalproduct>
        <drugbatchnumb>141392T</drugbatchnumb>
        <drugdosagetext>125 CC</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532726-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRA 300</medicinalproduct>
        <drugbatchnumb>04994T</drugbatchnumb>
        <drugdosagetext>100 CC</drugdosagetext>
        <drugindication>COMPUTERISED TOMOGRAM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532728-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRA 300</medicinalproduct>
        <drugbatchnumb>141392T</drugbatchnumb>
        <drugdosagetext>150 CC</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532729-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONTRAST MEDIA REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE REDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 370</medicinalproduct>
        <drugbatchnumb>192062T</drugbatchnumb>
        <drugdosagetext>100CC</drugdosagetext>
        <drugindication>COMPUTERISED TOMOGRAM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532730-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRA  300</medicinalproduct>
        <drugbatchnumb>049942T</drugbatchnumb>
        <drugdosagetext>150 CC</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532731-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532732-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.2554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN 200 MG IV</medicinalproduct>
        <drugbatchnumb>616301</drugbatchnumb>
        <drugdosagetext>200 MG Q 2 WKS IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUDR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532733-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP TERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>4 MG PO Q HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>4 MG PO Q HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532734-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEASONAL ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRA 300</medicinalproduct>
        <drugbatchnumb>141632T</drugbatchnumb>
        <drugdosagetext>100 CC</drugdosagetext>
        <drugindication>COMPUTERISED TOMOGRAM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532735-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>SNEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 300</medicinalproduct>
        <drugdosagetext>125 CC</drugdosagetext>
        <drugindication>COMPUTERISED TOMOGRAM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532737-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979795</companynumb>
    <primarysource>
      <qualification>3</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532738-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979796</companynumb>
    <primarysource>
      <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>BRUXISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/ 1 DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532739-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979806</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>20 MG/1 IN THE MORNING</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532742-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041079837</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG96R</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532743-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041079843</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532744-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041079845</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>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532745-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041079862</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532746-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041079868</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532747-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041079871</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532748-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041079873</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIP BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>60 MG DAY    (DURATION: A FEW YEARS)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532749-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419509US</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANGIOSARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXERCALCIFEROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGIOSARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041210</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532750-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419082US</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532751-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979753</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/ 1 DAY</drugdosagetext>
        <drugindication>DEPRESSIVE SYMPTOM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532752-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979758</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG IN THE MORNING</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532753-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979762</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532754-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979766</companynumb>
    <primarysource>
      <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>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXIS (FUROSEMIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532755-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979771</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532756-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979772</companynumb>
    <primarysource>
      <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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532757-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979780</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532758-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979784</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00Z</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532759-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979786</companynumb>
    <primarysource>
      <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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532760-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979787</companynumb>
    <primarysource>
      <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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532761-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979704</companynumb>
    <primarysource>
      <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>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532762-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979706</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532763-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979708</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG98S</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL (CALCIUM CARBONATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532764-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRA 370</medicinalproduct>
        <drugbatchnumb>192062T</drugbatchnumb>
        <drugdosagetext>135 CC</drugdosagetext>
        <drugindication>COMPUTERISED TOMOGRAM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532765-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979710</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/ 1DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC (OMEPRAZOLE RATIOPHARM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532766-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 150</medicinalproduct>
        <drugbatchnumb>192062T</drugbatchnumb>
        <drugdosagetext>120 CC</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532767-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979714</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532768-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCUMORAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 300</medicinalproduct>
        <drugbatchnumb>151562T</drugbatchnumb>
        <drugdosagetext>80 CC IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532769-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 300</medicinalproduct>
        <drugbatchnumb>182052T</drugbatchnumb>
        <drugdosagetext>100 CC IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532770-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979718</companynumb>
    <primarysource></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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG IN THE MORNING</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532771-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979727</companynumb>
    <primarysource>
      <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>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532772-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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 INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>GM4890</drugbatchnumb>
        <drugdosagetext>1 PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532773-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532776-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.9874</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>75 MG 3 X DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>75 MG 3 X DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041219</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532780-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532784-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979728</companynumb>
    <primarysource>
      <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>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532785-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979739</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN (GABAPENTIN PFIZER)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM (LIDOCAINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532786-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979744</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00Z</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532787-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1755</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD OSMOLARITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OSMOLARITY INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugauthorizationnumb>75482</drugauthorizationnumb>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORMAZEPAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532788-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-YAMANOUCHI-YEHQ20040449</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCOMMODATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESIKUR ()</medicinalproduct>
        <drugauthorizationnumb>21518</drugauthorizationnumb>
        <drugdosagetext>5 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXONIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532789-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-YAMANOUCHI-YEHQ20040444</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>21518</drugauthorizationnumb>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532790-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081393</companynumb>
    <primarysource>
      <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>CHEST WALL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEBETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN (GABAPENTIN PFIZER)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532791-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1735</companynumb>
    <primarysource>
      <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>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>74949</drugauthorizationnumb>
        <drugdosagetext>250-450 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532792-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081402</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>8RG04M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532793-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-10-1484</companynumb>
    <primarysource>
      <qualification>3</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>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>74949</drugauthorizationnumb>
        <drugdosagetext>700MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugbatchnumb>4809A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532794-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081403</companynumb>
    <primarysource></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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>20 MG/1 DAY</drugdosagetext>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532795-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1751</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>74949</drugauthorizationnumb>
        <drugdosagetext>400MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532796-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041204</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXBR2004US00460</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugbatchnumb>143096</drugbatchnumb>
        <drugauthorizationnumb>75209</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN (EZETIMIBE, SIMVASTATIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532797-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081404</companynumb>
    <primarysource>
      <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>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532798-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081406</companynumb>
    <primarysource>
      <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>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532799-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004105148</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEOSPORIN</medicinalproduct>
        <drugbatchnumb>2LOT48251L</drugbatchnumb>
        <drugdosagetext>AS NEEDED, TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>SKIN DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEOSPORIN</medicinalproduct>
        <drugbatchnumb>217474L</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANASTROZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUG, UNSPECIFIED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532800-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081419</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA 3 (FISH OIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN (GABAPENTIN PFIZER)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532801-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BR16117</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELMAC</medicinalproduct>
        <drugdosagetext>6 MG, QD</drugdosagetext>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELMAC</medicinalproduct>
        <drugdosagetext>6 MG/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532802-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004107050</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.3597</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GALLBLADDER OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEHISCENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISTERINE (MENTHOL, METHYL SALICYLATE, EUCALYPTOL, THYMOL)</medicinalproduct>
        <drugdosagetext>1/2 CAPFUL TID, ORAL TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DENTAL DISORDER PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532803-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081422</companynumb>
    <primarysource>
      <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>AURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532804-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004GR14917</companynumb>
    <primarysource>
      <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>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMAL NEWBORN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugdosagetext>20 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>5-FU + EPIRUBICIN + CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>5 CYCLES</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>28 GY (8 FRACTIONS)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532805-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081429</companynumb>
    <primarysource>
      <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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040911</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532806-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CL16737</companynumb>
    <primarysource>
      <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>TESTICULAR EMBRYONAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEPONEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532807-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004ES16556</companynumb>
    <primarysource>
      <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>COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532809-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081430</companynumb>
    <primarysource></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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN (GABAPENTIN PFIZER)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532811-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081432</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532814-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004IT16642</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOLOGOUS BONE MARROW TRANSPLANTATION THERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
        <drugtreatmentduration>666</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532815-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004AP000841</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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugbatchnumb>GP3931</drugbatchnumb>
        <drugauthorizationnumb>75911</drugauthorizationnumb>
        <drugdosagetext>2 TBSP ; 3 TIMES A DAY; ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC ENCEPHALOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532817-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP06829</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOPULMONARY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040520</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON PREPARATIONS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532818-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081340</companynumb>
    <primarysource>
      <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>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00Z</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532819-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16773</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTAL PANNICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532822-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugbatchnumb>0314947</drugbatchnumb>
        <drugdosagetext>ONE PATCH   7 DAYS   TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>MENSTRUATION IRREGULAR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532824-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE   20MG</medicinalproduct>
        <drugdosagetext> 1               1           ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532830-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081341</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532834-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081348</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>95</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532837-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040920</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US10157</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTIVE NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXY CUT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532839-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004KR16686</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>300 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
        <drugtreatmentduration>141</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRMATE</medicinalproduct>
        <drugdosagetext>50 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
        <drugtreatmentduration>127</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532840-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081350</companynumb>
    <primarysource>
      <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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>NEUROPATHIC PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN (GABAPENTIN PFIZER)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532842-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081353</companynumb>
    <primarysource>
      <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>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00Z</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532844-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US11273</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY COLON ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONOSCOPY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>.1 MG, QD</drugdosagetext>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>300 MG, TID</drugdosagetext>
        <drugindication>NEUROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugdosagetext>20 MEQ, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>ANTACID THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXATIVES</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532847-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081354</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532850-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081357</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BINGE EATING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532852-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OXCD20040001</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </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>ANOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED BRONCHIAL SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM DISCOLOURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE (SAME AS PERCOLONE)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532854-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081362</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532856-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OXCD20040002</companynumb>
    <primarysource>
      <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>ACCIDENTAL DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICOLOGIC TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE (SAME AS PERCOLONE)</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532859-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP14919</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIFE SUPPORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC INFLAMMATORY RESPONSE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>50 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040209</drugenddate>
        <drugtreatmentduration>1144</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BREDININ</medicinalproduct>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040209</drugenddate>
        <drugtreatmentduration>1144</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BREDININ</medicinalproduct>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040209</drugenddate>
        <drugtreatmentduration>1144</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRENOCORTICOTROPHIC HORMONE</medicinalproduct>
        <drugdosagetext>10 MG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532860-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugbatchnumb>C400161</drugbatchnumb>
        <drugdosagetext>  ONE   DAILY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugbatchnumb>C400161</drugbatchnumb>
        <drugdosagetext>  ONE   DAILY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040910</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532862-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OXCD20040003</companynumb>
    <primarysource>
      <qualification>2</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>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE (SAME AS PERCOLONE)</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532863-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US11305</companynumb>
    <primarysource>
      <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>BIOPSY COLON ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS MICROSCOPIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTIVE NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532864-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12476</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>5 MG, QHS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>750 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>10 ML, PRN</drugdosagetext>
        <drugindication>COUGH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FROVATRIPTAN</medicinalproduct>
        <drugdosagetext>UNK MG, PRN</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX ^CERENEX^</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>200 MG, QHS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532866-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3075</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOLERANCE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>1 TAB/2 TAB    DAY/1WK/2  WK   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>1 TAB   DAY    ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532867-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081364</companynumb>
    <primarysource>
      <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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532869-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>OXCD20040004</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPIL FIXED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE (SAME AS PERCOLONE)</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532870-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US11305</companynumb>
    <primarysource>
      <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>BIOPSY COLON ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS MICROSCOPIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTIVE NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532872-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13139</companynumb>
    <primarysource>
      <qualification>3</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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4MG Q MONTH</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040430</drugenddate>
        <drugtreatmentduration>691</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugdosagetext>100 MCG Q72H</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>1-2 TABS PEN</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>300 G, TID</drugdosagetext>
        <drugindication>NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugdosagetext>100 G, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>15 MG, BID</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugdosagetext>200 MCG Q2W</drugdosagetext>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040820</drugenddate>
        <drugtreatmentduration>249</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
        <drugtreatmentduration>679</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040926</drugenddate>
        <drugtreatmentduration>44640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>100MG QD FOR 4DAYS Q4W</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>60 MG QD FOR 4DAYS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>80MG Q4DAYS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
        <drugtreatmentduration>70560</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugdosagetext>40MG Q4D Q4W</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugdosagetext>10 MG QD X4D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN</medicinalproduct>
        <drugdosagetext>40MG QD X4D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
        <drugtreatmentduration>70560</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532874-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081373</companynumb>
    <primarysource>
      <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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532880-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00536</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.30 MG, IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANZEMET (DOLASETRON MESILATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MGOXIDE (MAGNESIUM OXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532881-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081294</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532883-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00539</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGHT CHAIN ANALYSIS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NDC   63030-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.60 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532885-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13153</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG MONTHLY</drugdosagetext>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532886-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13207</companynumb>
    <primarysource>
      <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532887-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00677</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532889-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13172</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLECTOMY PARTIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugindication>IMPAIRED GASTRIC EMPTYING</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532891-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13259</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532892-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00685</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PIGMENTATION CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAVIK</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532896-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080837</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/D AT BEDTIME</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR (SIMVASTATIN RATIOPHARM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532898-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082345</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532899-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00691</companynumb>
    <primarysource>
      <qualification>3</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>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532900-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13336</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COLON NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532901-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00707</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NDC   63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.21 MG, IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>1.70 MG, IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOFRANIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532902-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080840</companynumb>
    <primarysource>
      <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532904-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030522</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2003GB02133</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEGACOLON ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE UROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH SCALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>200MG/MANE+300MG/NOCTE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>200MG/MANE+250MG/NOCTE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>400MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532906-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040607</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB02341</companynumb>
    <primarysource>
      <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>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAPILLARY NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>350MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>450MG/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532907-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080848</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532910-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00708</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NDC 63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532912-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080860</companynumb>
    <primarysource>
      <qualification>3</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>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL ^BELUPO^ (ALLOPURINOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532916-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04538</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>5760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>400MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532917-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004CA16748</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040614</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532918-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082347</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532919-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080864</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG40P</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 IN THE MORNING</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532920-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030611</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2003CZ07484</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030228</drugenddate>
        <drugtreatmentduration>123</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532922-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082365</companynumb>
    <primarysource></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>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>NERVOUSNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN (NAPROSYN MEPHA)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532923-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004FR15637</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH VESICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KENZEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMATOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
        <drugtreatmentduration>50400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532924-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2004AU01680</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>25 - 725 MG/DAY</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESMOPRESSIN</medicinalproduct>
        <drugdosagetext>2 TABLETS/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAFORMIN</medicinalproduct>
        <drugdosagetext>1 TABLET TWICE DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JEZIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532925-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080866</companynumb>
    <primarysource>
      <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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532926-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080868</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG95S</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532929-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080888</companynumb>
    <primarysource>
      <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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532930-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00747</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>IV DRIP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532931-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082378</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532933-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE04163</companynumb>
    <primarysource>
      <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</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION PLEURAL CAVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL DRAINAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYSEROSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041209</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532935-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00773</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>0.70 MG/M2, IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE (THALIDOMIDE)</medicinalproduct>
        <drugdosagetext>50.00 MG</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532936-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080736</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532938-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00815</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NDC 63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532939-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080760</companynumb>
    <primarysource>
      <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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532942-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080773</companynumb>
    <primarysource>
      <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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532943-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081299</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532944-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>M04-341-108</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>WB003A1</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.30 MG, 2/WEEK, IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORETIC 100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRCO-K</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532945-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080775</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 5</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532946-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081304</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532947-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080788</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041009</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532948-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082385</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX (ALPROXAZOLAM DUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532949-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080791</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532950-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040913</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BR12092</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELLARIL</medicinalproduct>
        <drugdosagetext>500 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENTAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOLITIUM</medicinalproduct>
        <drugdosagetext>300 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENTAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugdosagetext>2 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINOTOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugdosagetext>1 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugdosagetext>2 DF, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>10 MG, QHS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>5 TABLETS/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532951-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081316</companynumb>
    <primarysource>
      <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>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532952-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080803</companynumb>
    <primarysource>
      <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>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532953-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040820</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00294</companynumb>
    <primarysource>
      <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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUTTOCK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.10 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT (ERYTHROPOIETIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICOPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAVIK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532955-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080819</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGEN NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532956-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081323</companynumb>
    <primarysource>
      <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>TRISMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>FATIGUE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532957-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040813</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00365</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</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>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532959-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080832</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532960-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00397</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.70 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532961-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081326</companynumb>
    <primarysource>
      <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>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROSTAT (DEXAMFETAMINE SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532962-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>147</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532963-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080671</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONE REPLACEMENT THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532964-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00405</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BURNING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.70 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532965-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080680</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00Z</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugbatchnumb>8ED84A</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532966-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41.7309</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMINYL</medicinalproduct>
        <drugdosagetext>12 MG  ONE/DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040625</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532967-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00451</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</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>20040224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040824</drugenddate>
      </drug>
      <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>20031230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532968-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080681</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532969-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040903</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00464</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TESTICULAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.70 MG, IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532970-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080686</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG95P</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>90 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS WITH MINERALS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532971-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.0906</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugdosagetext>20MG  1 PER DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041218</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532972-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080690</companynumb>
    <primarysource>
      <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>AGITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97P</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532973-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA 041080706</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532974-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419615US</companynumb>
    <primarysource>
      <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>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLEGRA-D</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DDAVP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532975-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413513JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIBASIC CALCIUM PHOSPHATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINORIL</medicinalproduct>
        <drugdosagetext>DOSE: 4 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLAKAY</medicinalproduct>
        <drugdosagetext>DOSE: 2 CAPSULES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
        <drugdosagetext>DOSE: 2 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>DOSE: 1 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532976-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410102JP</companynumb>
    <primarysource>
      <qualification>3</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>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEPOLAS</medicinalproduct>
        <drugadministrationroute>003</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532977-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414058FR</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532978-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414440FR</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY ON ORAL CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOSUPPRESSIVE AGENTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN INTRAVENOUS (HUMAN)</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040706</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532979-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040408</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200412808US</companynumb>
    <primarysource>
      <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 PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTOLIC HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>DOSE: 1-10</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990317</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIDAURA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>DOSE: 50,000; DOSE UNIT: UNITS</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS, PLAIN</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEMASTINE FUMARATE AND PHENYLPROPANOLAMINE HCL</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>DOSE: 1/2</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS, PLAIN</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532980-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532981-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080717</companynumb>
    <primarysource>
      <qualification>2</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532982-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081332</companynumb>
    <primarysource>
      <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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>20 MG/TWICE DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532983-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REGURGITATION OF FOOD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60 MG ONCE DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSTHYMIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60 MG ONCE DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60 MG ONCE DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIEST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532984-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080719</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG95S</drugbatchnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVINZA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532986-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.1219</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>1 A DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532987-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040903</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00467</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>BID</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532988-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080726</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>40 MG DAY</drugdosagetext>
        <drugindication>NEUROPATHY</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532990-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080731</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINDOPRIL W/HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532991-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50.8029</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>75MG  1X DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>75MG  1X DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STRESS SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041029</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532993-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200MG  DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532995-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081235</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYFAST (OXYCODONE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532996-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00486</companynumb>
    <primarysource>
      <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>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.30 MG/M2, IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4532998-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081250</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/D IN THE MORNING</drugdosagetext>
        <drugindication>NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533002-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00522</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>105.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHALAZION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.80 MG, IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D (ERGOCALCIFEROL, CALCIUM SODIUM LACTATE, CALCIU</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICYCLOMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533003-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080625</companynumb>
    <primarysource>
      <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>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533005-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082215</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533006-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080626</companynumb>
    <primarysource>
      <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>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533007-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082247</companynumb>
    <primarysource>
      <qualification>1</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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533008-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080635</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533010-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082249</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533011-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080645</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG96R</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533012-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-BRISTOL-MYERS SQUIBB COMPANY-12794038</companynumb>
    <primarysource>
      <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>ELECTROCARDIOGRAM ST SEGMENT DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850212</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850212</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850212</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugdosagetext>5000 RAD.</drugdosagetext>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533013-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12795126</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>ADMINISTERED OVER 1 HOUR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANZEMET</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN OINTMENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533015-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040913</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12699104</companynumb>
    <primarysource>
      <qualification>2</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>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
        <drugindication>CHRONIC SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HCL</medicinalproduct>
        <drugindication>CHRONIC SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugindication>CHRONIC SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA-D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533016-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12799706</companynumb>
    <primarysource>
      <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>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENTRICULAR DYSFUNCTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENTRICULAR DYSFUNCTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATINE</medicinalproduct>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugdosagetext>2 PUFFS TWICE DAILY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533017-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080657</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533018-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12799466</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENKAID</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533019-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082260</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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/ 1 DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533020-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-BRISTOL-MYERS SQUIBB COMPANY-12794004</companynumb>
    <primarysource>
      <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>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE INVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850213</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850213</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850213</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533021-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-BRISTOL-MYERS SQUIBB COMPANY-12793899</companynumb>
    <primarysource>
      <qualification>3</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>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533024-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082261</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533027-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081152</companynumb>
    <primarysource></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>BUTTOCK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
        <drugindication>FACIAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCYAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533028-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081165</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG99R</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533029-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082275</companynumb>
    <primarysource>
      <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>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533030-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>04P-163-0246496-00</companynumb>
    <primarysource>
      <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>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugdosagetext>500 MG, 2 IN 1 D, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSELTAMIVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533032-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>04P-163-0250228-00</companynumb>
    <primarysource>
      <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>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugdosagetext>2 DOSAGE FORMS, 1 IN 1 D, PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040212</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533033-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081167</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/ 1 DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533034-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040319</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>04P-163-0254066-00</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugindication>TONSILLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040302</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533035-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082282</companynumb>
    <primarysource></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>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533036-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081173</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/ 1 DAY</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533037-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00372</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NDC 63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2/WEEK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIAC THERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533038-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081704</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBYAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUVOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533039-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00384</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NDC 63020-049-01</drugbatchnumb>
        <drugdosagetext>3.00 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533040-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081184</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPERTENSION MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533042-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081714</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTIVE NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533043-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00390</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NDC 63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.00 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533044-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081186</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533045-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081717</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533046-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00403</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NDC 63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.50 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533047-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081735</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR (SIMVASTATIN RATIOPHARM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533048-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040827</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00422</companynumb>
    <primarysource>
      <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>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NDC 63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533049-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081741</companynumb>
    <primarysource>
      <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>STRABISMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX (VALACICLOVIR)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>(ESOMEPRAZOLE MAGNESIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM (LIDOCAINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533050-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414689FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRANULOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTRAPID</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOMIX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533051-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413923JP</companynumb>
    <primarysource>
      <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>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALONAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533052-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200422225GDDC</companynumb>
    <primarysource>
      <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>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUTRINEAL PD4</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533053-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414011FR</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533054-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413729JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHROMATOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETEK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELCITONIN</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533055-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200416288GDDC</companynumb>
    <primarysource>
      <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>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DEEP VENOUS THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS GLUCONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040603</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533056-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200417918US</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>D054</drugbatchnumb>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSLO</medicinalproduct>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533057-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200418041US</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>204.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-ABDOMINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 1 MG/KG (170 MG)</drugdosagetext>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: 1 MG/KG (170 MG)</drugdosagetext>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533058-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200422159GDDC</companynumb>
    <primarysource>
      <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>BREECH PRESENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOMID</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANOVULATORY CYCLE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533059-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414752FR</companynumb>
    <primarysource></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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTHYMIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESSENTIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGAMMAGLOBULINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASILIX FAIBLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSTHYMIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEMIGOXINE NATIVELLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040519</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533060-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414630FR</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533061-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414639FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISCITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPALGIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IDARAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOCIN HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIPARINE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMAREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEVARYL</medicinalproduct>
        <drugadministrationroute>003</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORLAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALACINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533062-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414751FR</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH SCARLATINIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL RESECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEBCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIBERAL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRANXENE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533063-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419657US</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.1</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>DOSE UNIT: UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030205</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533064-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00443</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NDC  63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533065-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081743</companynumb>
    <primarysource>
      <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533066-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00447</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NDC   63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533067-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081201</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533068-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081745</companynumb>
    <primarysource>
      <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>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBERCON (POLYCARBOPHIL CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE CHONDROITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON (MIRTAZAPINE ORIFARM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533069-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081204</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG39P</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC (OMEPRAZOLE RATIOPHARM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533070-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPULSIVE BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARITAL PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041024</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533071-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081748</companynumb>
    <primarysource>
      <qualification>3</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533072-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00448</companynumb>
    <primarysource>
      <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>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.30 MG/M2, IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533073-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.3273</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugdosagetext>40-80 MG DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19870523</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533074-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081752</companynumb>
    <primarysource>
      <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>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533075-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG Q6 AND HS PARENTERAL</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG Q6 AND HS PARENTERAL</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>2 Q8H PARENTERAL</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041211</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533076-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00455</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NDC   63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533077-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040323</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-NOVOPROD-236076</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORTISOL FREE URINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHING'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN SIMPLEXX</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040318</drugenddate>
        <drugtreatmentduration>661</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040319</drugenddate>
        <drugtreatmentduration>478</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINIRIN ^FERRING^</medicinalproduct>
        <drugdosagetext>.1 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERON - SLOW RELEASE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-THYROXIN ^HENNING BERLIN^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugdosagetext>0.5 I.V./KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAIZEN</medicinalproduct>
        <drugdosagetext>0.5 I.V./KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORDITROPIN</medicinalproduct>
        <drugdosagetext>0.6 I.V./KG.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533078-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081763</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533079-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040903</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00470</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>WB004A1</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.00 MG, IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533080-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081779</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533081-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041209</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>HQWYE932111FEB04</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.21</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LODINE XL</medicinalproduct>
        <drugauthorizationnumb>20584</drugauthorizationnumb>
        <drugdosagetext>500 MG 1X PER 1 DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533082-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081800</companynumb>
    <primarysource>
      <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>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>8RG04P</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533083-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081807</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>136</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG96R</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533084-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00472</companynumb>
    <primarysource>
      <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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040903</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLOPRIM (ALLOPURINOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533085-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081811</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZADONE (TRAZODONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533086-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00515</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENERLAC (LACTULOSE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE IN PLASTIC CONTAINER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT (ERYTHROPOIETIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533087-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081211</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG IN THE MORNING</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533088-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081216</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG95S</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/ 1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIVELLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533089-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KE-NOVOPROD-240392</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIXTARD HUMAN 70/30</medicinalproduct>
        <drugbatchnumb>NS63035</drugbatchnumb>
        <drugdosagetext>40 U, UNK</drugdosagetext>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugindication>INSULIN-REQUIRING TYPE II DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533090-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00525</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040610</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533091-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00530</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533092-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081816</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533093-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102.0593</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>150  1X</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533094-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081139</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA (DULOXETINE HYDROCHLORIDE)</medicinalproduct>
        <drugbatchnumb>7SH00Z</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/TWO AT NIGHT</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533095-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081826</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533096-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081834</companynumb>
    <primarysource>
      <qualification>3</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/ 1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533097-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081142</companynumb>
    <primarysource>
      <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>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA (DULOXETINE HYDROCHLORIDE)</medicinalproduct>
        <drugbatchnumb>7SG97R</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>120 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533098-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081838</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533099-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081102</companynumb>
    <primarysource></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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA (DULOXETINE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZYLHYDROCHLORTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533100-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081842</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>120 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVE PILL (ORAL CONTRACEPTIVE NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533101-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081113</companynumb>
    <primarysource>
      <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>GALACTORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA (DULOXETINE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533102-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081844</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533103-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081118</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA (DULOXETINE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533104-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00531</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.90 MG 2/WEEK IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533105-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081848</companynumb>
    <primarysource>
      <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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533106-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00547</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</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>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533107-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12793642</companynumb>
    <primarysource>
      <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>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PSORIAFORM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRIVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533108-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12774444</companynumb>
    <primarysource>
      <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>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AXEPIM INJ</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040922</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041004</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041006</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041005</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>INTERRUPTED FROM 21- TO 23-SEP-2004</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOMYST</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMBEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533109-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081856</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533110-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00549</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2/WEEK</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533111-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081121</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA (DULOXETINE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>40 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533112-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00567</companynumb>
    <primarysource>
      <qualification>3</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>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.30MG/M2 INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533113-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081868</companynumb>
    <primarysource>
      <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>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533114-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081870</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533115-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081127</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA (DULOXETINE HYDROCHLORIDE)</medicinalproduct>
        <drugbatchnumb>7SH00Z</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/2 DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KADIAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533117-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugdosagetext>12.5 MG  ONCE DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533118-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081134</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA (DULOXETINE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533119-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00568</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.30MG/M1 WEEK INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533120-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC POLYPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL POLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200MG  TWICE ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533121-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081883</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/ 1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533122-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00573</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.60 MG IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL (PRAVASTAIN SODIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (POTASSIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRESSTABS (VITAMINS NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533123-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.4003</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugbatchnumb>SAMPLES</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533124-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081886</companynumb>
    <primarysource>
      <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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533125-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.6068</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>250MG  Q DAY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041203</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533126-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081892</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESCRIBED OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>90 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533127-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081898</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVORPHANOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABITRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZADONE (TRAZODONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533128-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081135</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INITIAL INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA (DULOXETINE HYDROCHLORIDE)</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533129-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082292</companynumb>
    <primarysource>
      <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>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DYSTHYMIC DISORDER</drugindication>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVLITE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533130-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081899</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533131-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081137</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA (DULOXETINE HYDROCHLORIDE)</medicinalproduct>
        <drugbatchnumb>7SG40P</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533132-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082295</companynumb>
    <primarysource>
      <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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533133-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-12776860</companynumb>
    <primarysource>
      <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>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>245</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>245</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPINAVIR + RITONAVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
        <drugtreatmentduration>245</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533134-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082298</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533135-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-12798625</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugbatchnumb>04G18E1A</drugbatchnumb>
        <drugdosagetext>IN 500 ML NACL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041111</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533137-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>430076K04USA</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533139-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>430084K04USA</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETASERON (BETASER-ON)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL (METOPROLOL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533140-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081934</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533141-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>430041K04USA</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRANULOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVANTRONE</medicinalproduct>
        <drugauthorizationnumb>19297</drugauthorizationnumb>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533142-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081945</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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>40 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533145-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00421</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NDC 63020 049 01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.00 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE IN PLASTIC CONTAINER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533148-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081968</companynumb>
    <primarysource>
      <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>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>40 MG DAY</drugdosagetext>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG98P</drugbatchnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>NEPHROLITHIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URISED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533149-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040827</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00436</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NDC 63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPHALAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533152-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040827</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00438</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NDC 63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533153-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081039</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533154-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00454</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533156-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040903</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00469</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44.4525</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>WB004A1</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.00 MG, IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040524</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533159-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00511</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48.1</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533160-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-RB-1183-2004</companynumb>
    <primarysource>
      <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>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENCEPHALOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG ABUSER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533161-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082004</companynumb>
    <primarysource>
      <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>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533162-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082301</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533163-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00532</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.6 MG, BIW, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533164-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082042</companynumb>
    <primarysource>
      <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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533165-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RB-1180-2004</companynumb>
    <primarysource>
      <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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATIONS, MIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>DRUG WITHDRAWAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041113</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533166-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00535</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NDC 63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.30 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533168-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082307</companynumb>
    <primarysource>
      <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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVE PILL (ORAL CONTRACEPTIVE NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533169-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00546</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>121</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NDC 63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.00, IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040908</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533172-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00564</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NDC 63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.30 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533174-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082310</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533176-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-RB-1179-2004</companynumb>
    <primarysource>
      <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>HOARSENESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugdosagetext>2MG QD IV/SL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533178-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082320</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533181-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082327</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL (CARBAMAZEPINE RIVOPHARM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIGRAINE MED</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533184-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082341</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLEPHAROSPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533194-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081054</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG IN THE MORNING</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533200-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082147</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533202-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082150</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>8RG04M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533209-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082342</companynumb>
    <primarysource>
      <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>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00Z</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APO-METOPROLOL (METOPROLOL TARTRATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533211-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080984</companynumb>
    <primarysource>
      <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>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>30 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533213-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082189</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533214-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugdosagetext>1        3 MONTHS   INTRAMUSCU</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533215-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082192</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533217-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.5234</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>40MG    Q DAY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041219</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533218-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082205</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533220-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED ACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10MG   DAILY    ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040820</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533222-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.8331</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>5MG   DAILY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533223-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082209</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533224-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031010</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533225-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041082211</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533226-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.9874</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACERONE</medicinalproduct>
        <drugbatchnumb>01/45</drugbatchnumb>
        <drugdosagetext>800MG   2XDAY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG6</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533229-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>158.759</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE 0.9%</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533231-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081019</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZADONE (TRAZODONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533232-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081020</companynumb>
    <primarysource>
      <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>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533233-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></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>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugbatchnumb>IT402GN</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533236-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040875975</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINE DERMAL PATCH (NICOTINE RESIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533239-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080904</companynumb>
    <primarysource>
      <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>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533241-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080906</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533245-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ABBOTT-04P-151-0283046-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA PRIMARY ATYPICAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040112</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE REDUCED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSIVE HEART DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE MITE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533246-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-04P-062-0264277-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIC BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533248-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041211</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0283112-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERIDIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533249-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-04P-013-0283641-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEANXIT</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533251-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ABBOTT-04P-144-0283108-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533252-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ABBOTT-04P-144-0283105-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533254-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ABBOTT-04P-066-0283045-00</companynumb>
    <primarysource></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>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLARICID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041205</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBIVOLOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPROSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VARNIDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533255-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200402666</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.112</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>160 MG OTHER - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>160 MG OTHER - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533257-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0276960-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533258-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-04P-056-0283584-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENFUVIRTIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSEMPRENAVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533260-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200402695</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.4932</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE REDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>507386</drugbatchnumb>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>140 MG Q2W - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>507386</drugbatchnumb>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>140 MG Q2W - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>615568</drugbatchnumb>
        <drugdosagetext>140 MG Q2W INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533262-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876547</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533263-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200402700</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.4723</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>616290</drugbatchnumb>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>160 MG Q3W - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>616290</drugbatchnumb>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>160 MG Q3W - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATEGLINIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PALONOSETRON HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533264-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876569</companynumb>
    <primarysource>
      <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>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SONATA (AZALEPLON)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533265-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12796090</companynumb>
    <primarysource>
      <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>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TESTIS CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041214</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>TESTIS CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugindication>TESTIS CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533266-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12795696</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ACNEIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>START DATE 10-DEC-04, START DATE THIS COURSE 01-DEC-04</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>START DATE 10-NOV-04, THIS COURSE STARTED 01-DEC-04</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533267-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-12795720</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533268-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12793154</companynumb>
    <primarysource>
      <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>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANZEMET</medicinalproduct>
        <drugbatchnumb>A4188</drugbatchnumb>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533269-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-12798427</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031211</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UROMITEXAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031211</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031205</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031205</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533270-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533272-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533274-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200402712</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>123.832</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>18 OTHER - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>18 OTHER - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE SODIUM SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENYDRAMINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533277-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></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>
        <drugdosagetext>TABLET</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533278-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200402726</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.2043</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORY NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>165 MG Q2W - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031203</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533280-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200402760</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533282-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAMPATH</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533283-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004US16877</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE UROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIVALPROEX SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533284-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04567</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERBINAFINE HCL</medicinalproduct>
        <drugdosagetext>250MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041120</drugenddate>
        <drugtreatmentduration>64800</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugdosagetext>100MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXINE</medicinalproduct>
        <drugdosagetext>100 UG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533285-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040820</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200402870</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533286-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080914</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/ 1 DAY</drugdosagetext>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533287-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200402896</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>170 MG Q2W - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>170 MG Q2W - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>170 MG Q2W - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO LUNG</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRE-MEDICATION NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533288-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>200 MG QD</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533289-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080929</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG IN THE MORNING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533290-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080932</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533291-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040106</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2004AU00450</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>12 - 500 MG/DAY</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>12 - 600 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041214</drugenddate>
        <drugtreatmentduration>2410</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533292-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE03934</companynumb>
    <primarysource>
      <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>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCINTILLATING SCOTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD TESTS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533293-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CA16446</companynumb>
    <primarysource>
      <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>80 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533294-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03657</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD FOLATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COOMBS DIRECT TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITTING OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELLARIL</medicinalproduct>
        <drugdosagetext>7 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
        <drugtreatmentduration>21600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>2 G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
        <drugtreatmentduration>17280</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KARDEGIC                                /FRA/</medicinalproduct>
        <drugdosagetext>160 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OROCAL VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN THERAPY</medicinalproduct>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYSIOTHERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA RECEPTOR STIMULANTS</medicinalproduct>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533295-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080940</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/ 1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYPREXA (OLANZAPINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533296-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080966</companynumb>
    <primarysource>
      <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>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533297-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080974</companynumb>
    <primarysource>
      <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>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533298-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></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>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533299-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080976</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/ 1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533300-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040804</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP10422</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</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 CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCHOL</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040722</drugenddate>
        <drugtreatmentduration>2095</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERMION</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040722</drugenddate>
        <drugtreatmentduration>2095</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040722</drugenddate>
        <drugtreatmentduration>151</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHADOL</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040722</drugenddate>
        <drugtreatmentduration>470</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICHISTATE</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PLATELET AGGREGATION INHIBITION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040722</drugenddate>
        <drugtreatmentduration>179</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981028</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533301-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US11043</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041002</drugenddate>
        <drugtreatmentduration>426</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533302-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US11879</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONOSCOPY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABDOMEN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIGH FIBER DIET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELAFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041028</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533303-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13276</companynumb>
    <primarysource>
      <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>ZELNORM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533304-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004AR16957</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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE SEPARATION OF PLACENTA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELMAC</medicinalproduct>
        <drugdosagetext>18 MG/DAY</drugdosagetext>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>10080</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533305-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533306-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORICIDINE HBP COUGH AND COLD TABLETS (CHLORPHENIRAMINE MAL/DEX</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030414</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533307-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080978</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533308-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978065</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533309-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978067</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG639P</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/ 1 DAY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533310-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978072</companynumb>
    <primarysource></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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/ 1 IN THE MORNING</drugdosagetext>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533311-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978074</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>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/ 1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533312-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20021016</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2002DE00440</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5 MG/ DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FINLEPSIN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEMIPARESIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KARVEZIDE</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020807</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORFIRIL</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORFIRIL</medicinalproduct>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JENACARD</medicinalproduct>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533313-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978076</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533314-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978077</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533315-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978082</companynumb>
    <primarysource>
      <qualification>1</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>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533316-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978087</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533318-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978098</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533320-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00727</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.60 MG, IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533321-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978106</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533322-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-UK102014</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>PERIPHERAL BLOOD STEM CELL APHERESIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533323-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BR15370</companynumb>
    <primarysource>
      <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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugbatchnumb>352</drugbatchnumb>
        <drugdosagetext>100 IU, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533324-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200402909</companynumb>
    <primarysource>
      <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>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>N INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>N INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533325-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876783</companynumb>
    <primarysource>
      <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>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533326-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-AMGEN-UK102554</companynumb>
    <primarysource>
      <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>ANAESTHETIC COMPLICATION CARDIAC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMG 099073</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533327-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040811</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BR10672</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533328-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13258</companynumb>
    <primarysource>
      <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>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugdosagetext>200 IU, QD</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533329-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00758</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT (ERYTHROPOIETIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN (INSULIN HUMAN, INSULIN ISOPHANE, HUMAN BIOSYNTHETIC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM (MAGNESIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE VITAMINS (ERGOCALDIFEROL, VITAMIN B NOS, TOCOPHEROL, ASCORBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ICAR-C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LODERM (ERYTHROMYCIN ESTOLATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMANTINE (MIDODRINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533330-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BR15625</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533331-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16521</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</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>BONE SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DEPOSIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>75 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>15840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORADOL</medicinalproduct>
        <drugdosagetext>2 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>15840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOLEPTAN</medicinalproduct>
        <drugdosagetext>240 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPD</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>15840</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARZULENE S</medicinalproduct>
        <drugdosagetext>1.5 G/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>5 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>3522</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUNOBAL</medicinalproduct>
        <drugdosagetext>10 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>2332</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533332-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876784</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533333-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200402959</companynumb>
    <primarysource>
      <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>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>146 MG Q2W - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533334-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00764</companynumb>
    <primarysource>
      <qualification>2</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>CATHETER SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.00 MG, IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE (LEVEOTHYROXINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533336-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200403527</companynumb>
    <primarysource>
      <qualification>3</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>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533337-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200403529</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCCUPATIONAL EXPOSURE TO TOXIC AGENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>RESPIRATORY (INHALATION)</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533338-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004IN16953</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXCARBAZEPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533339-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876790</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00Z</drugbatchnumb>
        <drugdosagetext>30 MG/ 1 DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIVACTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN (BUPROPION HYROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533340-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13230</companynumb>
    <primarysource>
      <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>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533341-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13221</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>75 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041209</drugenddate>
        <drugtreatmentduration>4320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugdosagetext>88 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533342-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200403596</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORY NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533344-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200403655</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCCUPATIONAL EXPOSURE TO TOXIC AGENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>RESPIRATORY (INHALATION)</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533346-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200403748</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533348-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876845</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>105</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOB DISSATISFACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>5 MG DAY</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533349-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03687</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY SKIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOUS MEMBRANE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELISOR</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCO</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROVEL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533350-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200402406</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533351-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELANOSIS COLI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE ADHESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORRECTOL</medicinalproduct>
        <drugdosagetext>UNKNOWN ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEEN-A-MINT</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EX-LAX</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533352-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200402738</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEXPECTED THERAPEUTIC DRUG EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533353-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>4</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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORICIDIN HBP COUGH + COLD (CHLORPHENIRAMINE MAL/DEX TABLETS</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030414</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533354-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200402742</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCCUPATIONAL EXPOSURE TO TOXIC AGENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>RESPIRATORY (INHALATION)</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533355-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.9676</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEGAL PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORICIDIN HBP COUGH + COLD (CHLORPHENIRAMINE MAL/DEX TABLETS</medicinalproduct>
        <drugdosagetext>30 TABS  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040413</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533356-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE AFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILLARY REFLEX IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORICIDIN D SRT</medicinalproduct>
        <drugdosagetext>16 TABLETS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL MISUSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533357-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORICIDIN D SRT</medicinalproduct>
        <drugdosagetext>16 TABLETS ORAL   (DURATION: ONCE)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTENTIONAL MISUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANNABIS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533358-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORICIDIN HBP COUGH + COLD (CHLORPHENIRAMINE MAL/DEX  TABLETS</medicinalproduct>
        <drugdosagetext>16+ TABLETS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533359-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORICIDIN HBP COUGH + COLD (CHLORPHENIRAMINE MAL/DEX   TABLETS</medicinalproduct>
        <drugdosagetext>16+ TABLETS ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533360-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.1626</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25 MLG</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533361-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugdosagetext>100 MG PRN ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugdosagetext>100 MG PRN ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533362-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101.6057</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugdosagetext>0.85MG QD IVCI</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>400 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533363-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE URINARY TRACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRESSA</medicinalproduct>
        <drugdosagetext>250 MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533364-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>157.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugdosagetext>200 MG PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533365-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>36</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMODULIN</medicinalproduct>
        <drugdosagetext>22NG/KG/MIN CONTINOUS</drugdosagetext>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533366-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>IV INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533367-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533368-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugbatchnumb>01-085</drugbatchnumb>
        <drugdosagetext>200 MG BID X4/WEEK ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTOPHASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APAP TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533369-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030926</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-NOVOPROD-233067</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPODYSTROPHY ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVONORM 1.0 MG</medicinalproduct>
        <drugdosagetext>3 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS NON-INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030717</drugenddate>
        <drugtreatmentduration>73</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXATIN</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030509</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EURADAL</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALINE MIXTURE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030512</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533370-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00782</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</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>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533371-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00786</companynumb>
    <primarysource>
      <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>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533372-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00787</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533373-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200402882</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533374-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200402953</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48.9885</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>125 MG Q2W - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533375-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200402967</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>STRIDOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533376-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12795886</companynumb>
    <primarysource>
      <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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533377-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200402985</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533378-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200402995</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SENSITIVITY OF TEETH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533379-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200403285</companynumb>
    <primarysource>
      <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>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>RESPIRATORY (INHALATION)</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533380-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12734596</companynumb>
    <primarysource>
      <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>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugdosagetext>CY 2: 22SEP04 CY3:  13OCT04</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugdosagetext>CY 2: 22SEP04 CY 3: 13OCT04</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533381-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200403320</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTIONS INVOLUNTARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533382-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12793626</companynumb>
    <primarysource>
      <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>ESTRACE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCRIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533383-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040709</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12648861</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEUROBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030424</drugenddate>
        <drugtreatmentduration>1091</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UROMITEXAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEUROBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030424</drugenddate>
        <drugtreatmentduration>1091</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEUROBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030424</drugenddate>
        <drugtreatmentduration>1091</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANDA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEUROBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030424</drugenddate>
        <drugtreatmentduration>1091</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEUROBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030424</drugenddate>
        <drugtreatmentduration>1091</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533384-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12782777</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ALVEOLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533385-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12789533</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <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>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BARRETT'S OESOPHAGUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533386-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200403469</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533387-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-12796959</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO POSITIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040706</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533388-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16581</companynumb>
    <primarysource>
      <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>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533389-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00309</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>WB004A1</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.60 MG, IV BOLUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040402</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE (THALIDOMIDE)</medicinalproduct>
        <drugbatchnumb>WB004A1</drugbatchnumb>
        <drugdosagetext>150.00 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE (THALIDOMIDE)</medicinalproduct>
        <drugdosagetext>40.00 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533390-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00369</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.40 MG, IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040806</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533391-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00373</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NDC 63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.00 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533392-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00580</companynumb>
    <primarysource>
      <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>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NDC # 63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533393-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00376</companynumb>
    <primarysource>
      <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>HERPES ZOSTER INFECTION NEUROLOGICAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST HERPETIC NEURALGIA</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>20040705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040707</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533394-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00377</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>WB005A1</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.90 MG, IV BOLUS</drugdosagetext>
        <drugadministrationroute>023</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040611</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533395-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00389</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VENTRICULAR 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>20040603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533396-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-386457</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.1</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>STRENGTH: 180. DOSAGE REGIMEN: EVERY WEEK.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugdosagetext>DOSAGE REGIMEN: 400 EVERY MORNING (QAM), 100 EVERY EVENING (QPM)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040518</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533397-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00598</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533398-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ROCHE-383534</companynumb>
    <primarysource>
      <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>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANTED LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040612</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040605</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040610</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040605</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>ADJUSTED TO REACH PREDEFINED TARGET LEVELS.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040605</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>TAPERED ACCORDING TO LOCAL PROTOCOL.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
        <drugtreatmentduration>131</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>ALTERED DUE TO SUSPICION OF REJECTION.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041016</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>ALTERED DUE TO SUSPICION OF REJECTION.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>ALTERED DUE TO SUSPICION OF REJECTION.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>ALTERED DUE TO SUSPICION OF REJECTION.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>ALTERED DUE TO SUSPICION OF REJECTION.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODEOXYCHOLIC ACID</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM-SULFAMETHOXAZOLE</medicinalproduct>
        <drugindication>ANTIBACTERIAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040618</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533399-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00401</companynumb>
    <primarysource>
      <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>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE (THALIDOMIDE)</medicinalproduct>
        <drugbatchnumb>0086W</drugbatchnumb>
        <drugdosagetext>100.00 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533400-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00625</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLONIC OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NDC #63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.40 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533401-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ROCHE-383172</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533402-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00406</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NDC  63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>3.00 MG</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533403-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-375081</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE SUBCUTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE VESICLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVEDO RETICULARIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL HAEMOGLOBIN CONCENTRATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL VOLUME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL VOLUME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE PERCENTAGE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WRINKLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040715</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533404-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00629</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NDC# 63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.30 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE (THALIDOMIDE)</medicinalproduct>
        <drugdosagetext>50.00 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040315</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533405-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-383692</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA 2A (RO 25-8310)</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
        <drugtreatmentduration>106</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
        <drugtreatmentduration>107</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELTROXIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS GLUCONATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040712</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAVOL TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AXID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFATRIM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040718</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533406-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040907</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-380344</companynumb>
    <primarysource>
      <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>RETINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL PIGMENT EPITHELIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANTADIX</medicinalproduct>
        <drugdosagetext>DISCONTINUED PRIOR TO CLONAZEPAM AT AN UNKNOWN DATE.</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAHOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533407-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040804</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-376796</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCULUS URETERIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULAR HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR FOLLICLE TUMOUR BENIGN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTUSSUSCEPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE STOOLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS EXTERNA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATELLOFEMORAL PAIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE ADHESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND DEHISCENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>XANTHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCLOMETASONE DIPROPIONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE AND ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORABID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990204</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533408-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00407</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533409-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00416</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.21 MG, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN (PARACETAMOL, HYDROCOCDONE BITARTRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERI-COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (POTASSIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN (METFORMIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533410-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-385980</companynumb>
    <primarysource>
      <qualification>1</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>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROMECHANICAL DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugdosagetext>STRENGTH REPORTED AS 2.5ML.</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BCG VACCINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040315</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZMACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533411-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041029</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-385106</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.4</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>STRENTH REPORTED AS 2000 MG.  FOURTEEN DAYS ON SEVEN DAYS OFF.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533412-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-384369</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533413-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041211</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20041102417</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREPULSID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZURCALE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIOASPIRINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPIRIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOTEN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533415-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-389106</companynumb>
    <primarysource>
      <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>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION BACTERIAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FALSE LABOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533416-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-388491</companynumb>
    <primarysource>
      <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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS ANTIGEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRACHEOSTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DENOSINE IV</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CYTOMEGALOVIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBRACIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODACIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROID NOS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOSUPPRESSANT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD, PACKED RED CELLS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOCAL ANAESTHETICS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALKYLATING AGENTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS ADRENAL HORMONE PREPARATION.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533417-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-386324</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CD4 LYMPHOCYTES DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CD4/CD8 RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040523</drugenddate>
        <drugtreatmentduration>161</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000615</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533418-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ROCHE-387111</companynumb>
    <primarysource>
      <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>2</patientsex>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACLIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIMOXAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533419-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-389041</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE BONE MARROW APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugdosagetext>GIVEN ON DAY ONE AND DAY EIGHT. GIVEN IN THE CONTEXT OF A XELONAV PROTOCOL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533420-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-388930</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORYNEBACTERIUM INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040821</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533421-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-389081</companynumb>
    <primarysource>
      <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>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL EXUDATES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTERFERON ALFA NOS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040311</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533422-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-389051</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugdosagetext>3 TAKEN AM AND 2 TAKEN PM.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugdosagetext>3 TAKEN AM AND 2 TAKEN PM.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
        <drugdosagetext>ROUTE: TAKEN VIA PATCH. TAKEN EVERY 12 HOURS.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICOPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533423-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-389129</companynumb>
    <primarysource>
      <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>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>ROUTE REPORTED AS INJ.</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041204</drugenddate>
        <drugtreatmentduration>65</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041204</drugenddate>
        <drugtreatmentduration>65</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533424-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00630</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.20MG, IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT (ERYTHROPOIETIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUKINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533425-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-389237</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE MENOPAUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19840615</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533426-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-389132</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS LARGE AMOUNT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS LARGE AMOUNT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>DOSE REPORTED AS LARGE AMOUNT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533427-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-389267</companynumb>
    <primarysource>
      <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>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960615</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533428-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19990823</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SOLVAY-00302000402</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22486</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENTERITIS INFECTIOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 1 DF. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981005</drugenddate>
        <drugtreatmentduration>364</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CREON</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 3 G. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATITIS CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980819</drugenddate>
        <drugtreatmentduration>317</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CREON</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 3 G. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981005</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENFILL 20 R</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 1200 INTERNATIONAL UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981005</drugenddate>
        <drugtreatmentduration>364</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENFILL N</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 600 INTERNATIONAL UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS INSULIN-DEPENDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19981005</drugenddate>
        <drugtreatmentduration>364</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533429-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-389217</companynumb>
    <primarysource>
      <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>FACIAL PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL NERVE PALSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533430-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00640</companynumb>
    <primarysource>
      <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>4533431-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-389384</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROACUTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533432-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-389417</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>0.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULTRASOUND DOPPLER ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICARDIPINE HCL</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EUPRESSYL</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040411</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533433-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-389378</companynumb>
    <primarysource>
      <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>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010926</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011001</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011002</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>1137</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011120</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020407</drugenddate>
        <drugtreatmentduration>138</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040307</drugenddate>
        <drugtreatmentduration>700</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040311</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020925</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040307</drugenddate>
        <drugtreatmentduration>138</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040311</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>DISCONTINUED BETWEEN 25 SEP 2002 AND 22 OCT 2003.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040611</drugenddate>
        <drugtreatmentduration>990</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011112</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020925</drugenddate>
        <drugtreatmentduration>364</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALIMATE</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011008</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020925</drugenddate>
        <drugtreatmentduration>364</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAFUTIDINE</medicinalproduct>
        <drugdosagetext>REPORTED AS PROTECADIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020925</drugenddate>
        <drugtreatmentduration>364</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGIZONE</medicinalproduct>
        <drugdosagetext>DISCONTINUED BETWEEN 25 SEP 02 AND 22 OCT 03.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040307</drugenddate>
        <drugtreatmentduration>892</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGIZONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011108</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERO-GRADUMET</medicinalproduct>
        <drugdosagetext>DISCONTINUED BETWEEN 25 SEP 01 AND 22 OCT 03.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040307</drugenddate>
        <drugtreatmentduration>873</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTAT</medicinalproduct>
        <drugdosagetext>DISCONTINUED BETWEEN 25 SEP 02 AND 22 OCT 03.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040307</drugenddate>
        <drugtreatmentduration>872</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040611</drugenddate>
        <drugtreatmentduration>234</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040307</drugenddate>
        <drugtreatmentduration>138</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040510</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533434-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00651</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NDC#63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.30 MG/M2, 2/WEEK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE (THALIDOMIDE) TABLET</medicinalproduct>
        <drugdosagetext>50.00 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040315</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533435-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>RS004438-USA</companynumb>
    <primarysource>
      <qualification>5</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533436-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00652</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NDC# 63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.30 MG/M2, 2/WEEK, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE (:THALIDOMIDE)</medicinalproduct>
        <drugdosagetext>50.00 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040315</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533437-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040618</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>RS004550-USA</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533438-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>RS004588-USA</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SECTRAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533439-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00670</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NDC #63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NDC #63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533440-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040722</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE02610</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC DISORDER</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>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS ROTAVIRUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUTAMATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENTERITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040618</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVONORM</medicinalproduct>
        <drugdosagetext>.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCOL</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040618</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533441-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00715</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533442-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>RS004649-USA</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>SEE IMAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN (ASPIRIN PLUS C)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533443-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04563</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUVASTATIN SODIUM</medicinalproduct>
        <drugdosagetext>40MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>10MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>10MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-PROXAMOL</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>UNK, CONT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533444-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01367</companynumb>
    <primarysource>
      <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>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533445-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01622</companynumb>
    <primarysource>
      <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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533446-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>RS004728-USA</companynumb>
    <primarysource>
      <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>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOOL ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533447-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03602</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533448-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00141</companynumb>
    <primarysource>
      <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>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533449-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0407USA00316</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>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLETON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533450-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>RS004769-USA</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533451-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0411USA03465</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER PYLORI IDENTIFICATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
        <drugtreatmentduration>143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040614</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THERAPEUTIC PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040515</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEO-DUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040917</drugenddate>
        <drugtreatmentduration>143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533452-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP17050</companynumb>
    <primarysource>
      <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>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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>125 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040908</drugenddate>
        <drugtreatmentduration>97920</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533453-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13395</companynumb>
    <primarysource>
      <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>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugtreatmentduration>60480</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533454-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>RS003983-USA</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASODILATION PROCEDURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL ULCER HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533455-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>RS004011-USA</companynumb>
    <primarysource>
      <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>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533456-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>RS004174-USA</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.586</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FULL BLOOD COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040123</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533457-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00497</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS NONINFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>KNEE ARTHROPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021114</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERTOPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021201</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELOC-ZOK</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIFITERAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIBACEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533458-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>RS004191-USA</companynumb>
    <primarysource>
      <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>ACIPHEX</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533459-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>RS004199-USA</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1 N 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533460-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200403470</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FULL BLOOD COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC URAEMIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533461-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>RS004232-USA</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>40 MG, 2 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX (PANTROPRAZOLE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533462-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200403514</companynumb>
    <primarysource>
      <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>RETINAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533463-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>RS004289-USA</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533464-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040303</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>RS004291-USA</companynumb>
    <primarysource>
      <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>ACIPHEX</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1 IN 1 D, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533465-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040303</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>RS004292-USA</companynumb>
    <primarysource>
      <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>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533466-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040415</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>RS004391-USA</companynumb>
    <primarysource>
      <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>ACIPHEX</medicinalproduct>
        <drugauthorizationnumb>20973</drugauthorizationnumb>
        <drugdosagetext>20 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533467-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13434</companynumb>
    <primarysource>
      <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>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041122</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533468-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0302USA00066</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICOBRACHIAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS HELICOBACTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPARATHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLANTAR FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTPERICARDIOTOMY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROSTERNAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULNAR NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERICARDITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELAFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROSTAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000928</drugenddate>
        <drugtreatmentduration>100</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000928</drugenddate>
        <drugtreatmentduration>100</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533469-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200403557</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533470-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0412USA00629</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MENINGITIS ASEPTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533471-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00882</companynumb>
    <primarysource>
      <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>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHONDROMALACIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KERATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPETROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MURO 128 OPHTHALMIC OINTMENT</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIFICIAL TEARS</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESIC OR ANESTHETIC (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533472-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040924</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>800142</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>154.223</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERITONITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>NA01</drugbatchnumb>
        <drugauthorizationnumb>17512</drugauthorizationnumb>
        <drugdosagetext>18 L; QD; INTRAPERITONEAL</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHPLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>E.E.S.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL PM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHULAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGULAR INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN LISPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533473-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040924</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>800143</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>154.223</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERITONITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>NA01</drugbatchnumb>
        <drugauthorizationnumb>17512</drugauthorizationnumb>
        <drugdosagetext>18 L; QD; INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040903</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHPLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>E.E.S.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL PM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHULAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGULAR INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN LISPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533474-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200403667</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533475-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA04179</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533476-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US102459</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040729</drugenddate>
        <drugtreatmentduration>872</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031228</drugenddate>
        <drugtreatmentduration>376</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL SUPPLEMENT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040811</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533477-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031121</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0311USA02526</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE BURNING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</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>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA PAROXYSMAL NOCTURNAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM Q WAVES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXERCISE TOLERANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODILUTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPERATIVE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</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>PLEURITIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011110</drugenddate>
        <drugtreatmentduration>284</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011110</drugenddate>
        <drugtreatmentduration>284</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIBACTERIAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MOTION SICKNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANALGESIC EFFECT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
        <drugtreatmentduration>336</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERZONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIBACTERIAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIBACTERIAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>VITAMIN B12 DEFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIBACTERIAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL MSD LP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETRIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533478-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200403676</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.1219</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>616281</drugbatchnumb>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>230 MG Q2W - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533479-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>800149</companynumb>
    <primarysource>
      <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>PERITONITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>NA01</drugbatchnumb>
        <drugauthorizationnumb>17512</drugauthorizationnumb>
        <drugdosagetext>ONCE; INTRAPERITONEAL</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533480-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>700328</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.4827</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>NA01</drugbatchnumb>
        <drugauthorizationnumb>17512</drugauthorizationnumb>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K-DUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIPSIPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYNTEC D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R-PER SLIDING SCALE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533481-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200403720</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRIDOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>145 MG Q2W - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533482-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>F03200400095</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>133 MG OTHER - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB - SOLUTION</medicinalproduct>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETACRYNIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533483-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040903</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040977906</companynumb>
    <primarysource>
      <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>DISSOCIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533484-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0410DEU00521</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFUSAL OF TREATMENT BY PATIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533486-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>F03200400097</companynumb>
    <primarysource>
      <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 PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN - SOLUTION</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN - SOLUTION</medicinalproduct>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040817</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN ALFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533487-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0411DEU00083</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533488-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0410AUS00120</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533490-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0410AUS00178</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030409</drugenddate>
        <drugtreatmentduration>646</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533491-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA01014</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRODIURIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533492-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>F03200400100</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB - SOLUTION</medicinalproduct>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN - SOLUTION</medicinalproduct>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533494-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE04235</companynumb>
    <primarysource>
      <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>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>0.5 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugtreatmentduration>40320</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>0.25 DF, QD</drugdosagetext>
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    </patient>
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  <safetyreport>
    <safetyreportid>4533495-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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      <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>ABSCESS JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533496-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US103082</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.9</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>ANAEMIA OF MALIGNANT DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533497-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-AMGEN-UK100802</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLEOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533499-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>F03200400106</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>130 MG/M2 ONCE - INRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>35 MG/M2 1/WEEK, INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533500-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US102301</companynumb>
    <primarysource>
      <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>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533501-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US096880</companynumb>
    <primarysource>
      <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>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533502-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NLWYE257503DEC04</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA CHLAMYDIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533503-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-UK102861</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXONIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOREM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533504-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978007</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY HESITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533505-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA02653</companynumb>
    <primarysource>
      <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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533506-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03353</companynumb>
    <primarysource>
      <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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INGROWING NAIL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
        <drugtreatmentduration>385</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
        <drugtreatmentduration>385</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533507-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03649</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>123</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGE INDETERMINATE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICOBRACHIAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-CARDIAC CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533508-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978020</companynumb>
    <primarysource>
      <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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533509-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-MERCK-0412BRA00062</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040508</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533510-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-MERCK-0412SWE00018</companynumb>
    <primarysource>
      <qualification>1</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>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040918</drugenddate>
        <drugtreatmentduration>223</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040918</drugenddate>
        <drugtreatmentduration>223</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533511-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00128</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VESTIBULAR NEURONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533512-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01605</companynumb>
    <primarysource>
      <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>SILENT MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLOPRIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533513-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978022</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENERGY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG96P</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG AT BEDTIME</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZADONE (TRAZODONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533514-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MERCK-0412AUS00057</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533515-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA04267</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533516-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978023</companynumb>
    <primarysource>
      <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>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7FH00Z</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533517-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01861</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040706</drugenddate>
        <drugtreatmentduration>1631</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533518-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01977</companynumb>
    <primarysource>
      <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>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041210</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533519-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040978034</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533520-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA00668</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533521-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-MERCK-0411BRA00179</companynumb>
    <primarysource>
      <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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040828</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533522-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NSADSS2003021126</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIPHYSES PREMATURE FUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>OTITIS MEDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010921</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533523-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040909665</companynumb>
    <primarysource>
      <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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533524-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041100310</companynumb>
    <primarysource>
      <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>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533525-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041204292</companynumb>
    <primarysource>
      <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>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0418271;0425683</drugbatchnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041214</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533526-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041204330</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugbatchnumb>0418271</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA</medicinalproduct>
        <drugdosagetext>25/100 MG, 1 IN 24 HOUR, ORAL</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROQUICK</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIGRIN-A</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFIRAX</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>2 TABLETS 6 TIMES DAILY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533527-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041007074</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>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533528-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041204916</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BONE NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533529-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20041204539</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OTOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533531-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041203479</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXABEPILONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533532-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041202589</companynumb>
    <primarysource>
      <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>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOCET</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENAZINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>HUNTINGTON'S CHOREA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THERALENE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERESTA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORETHINDRONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533533-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20040400665</companynumb>
    <primarysource>
      <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>ARTERIAL THROMBOSIS LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD FIBRINOGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN D DIMER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOXACIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040102</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040102</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SEGLOR</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>PINEALOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533534-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041204285</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPORANOX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HISTOPLASMOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533535-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA02104</companynumb>
    <primarysource>
      <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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533537-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080047</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00Z</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533538-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080059</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT NUCLEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPEN ANGLE GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00Z</drugbatchnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533541-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00045</companynumb>
    <primarysource>
      <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>ABNORMAL SENSATION IN EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL POLYPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533543-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040421</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0404USA02088</companynumb>
    <primarysource>
      <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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040327</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYMYCARD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENSERAZIDE HYDROCHLORIDE AND LEVODOPA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>REFLUX OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030106</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533544-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NLWYE257403DEC04</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533545-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-US103432</companynumb>
    <primarysource>
      <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>ANTI-ERYTHROPOIETIN ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETICULOCYTE PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRE-EXISTING DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533547-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB04565</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERBINAFINE HCL</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041105</drugenddate>
        <drugtreatmentduration>27360</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533550-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-NOVOPROD-240944</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROSMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN SIMPLEXX</medicinalproduct>
        <drugdosagetext>2.2 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN SIMPLEXX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533551-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03698</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAIL TINEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533552-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020920</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2002PL07013</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</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>BOWEL SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARBOHYDRATE ANTIGEN 125 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS ROTAVIRUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OOPHORECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAD</medicinalproduct>
        <drugdosagetext>1.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>8 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugindication>GASTROINTESTINAL INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533553-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE03580</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>16</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTINEOPLASTIC AGENTS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugdosagetext>5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>50400</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533554-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16897</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL CAVITY DRAINAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN</medicinalproduct>
        <drugdosagetext>300 UG/D</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INTESTINAL OBSTRUCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041119</drugenddate>
        <drugtreatmentduration>31680</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>120 MG/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>11520</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533555-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041079919</companynumb>
    <primarysource>
      <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>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533556-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041079920</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533557-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041079923</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMOCORTISON INY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM AND VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533558-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041079925</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG99M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/ 1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533560-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080010</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>96</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00Z</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533561-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080013</companynumb>
    <primarysource></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>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533562-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080020</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLAT AFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00M</drugbatchnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533563-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080024</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00Z</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533564-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080025</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY HESITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533565-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200402963</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.3586</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>100MG/M2 OTHER INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>200MG/M2/OTHER INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040804</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533566-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004UW23961</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533567-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200403011</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE BURNING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUSNOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533568-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004UW12686</companynumb>
    <primarysource>
      <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>MYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533569-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200403176</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4316</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>200 MG OTHER-INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533570-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004IT16767</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL TEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS DETACHMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
        <drugtreatmentduration>885</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533571-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004FI16044</companynumb>
    <primarysource>
      <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>BARRETT'S OESOPHAGUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533573-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200403213</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>110.2241</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AURICULAR SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>85MG/M2 Q2W INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533574-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004TW17052</companynumb>
    <primarysource>
      <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>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugindication>BONE MARROW TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATGAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSULFAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533575-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2003110782</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8435</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST WALL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>50 MG (PRN), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORTALIDONE (CHLORTALIDONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCOPHEROL CONCENTRATE CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER (ASCORBIC ACID, TOCOPHERYL ACETATE, RETINOL, ZINC, CALC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533576-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2003110452</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>50 MG, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE (ESOMEPRAZOLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533577-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004066133</companynumb>
    <primarysource></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>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533578-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040604</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004060469</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIAPISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533579-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE03412</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCITON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533580-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004CA16876</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAMVIR</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES SIMPLEX</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533581-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041202575</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>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUILONUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533582-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041006439</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40.82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040326</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533583-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20041201127</companynumb>
    <primarysource>
      <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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533584-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP16154</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>100 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040318</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>400 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
        <drugtreatmentduration>134</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugdosagetext>177 MG/D</drugdosagetext>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040121</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRAVIT</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
        <drugtreatmentduration>21600</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>49 MG/D</drugdosagetext>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040118</drugenddate>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSULFAN</medicinalproduct>
        <drugindication>BLOOD STEM CELL HARVEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040116</drugenddate>
        <drugtreatmentduration>2880</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATGAM</medicinalproduct>
        <drugindication>STEM CELL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533585-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004054398</companynumb>
    <primarysource>
      <qualification>2</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>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533586-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004047359</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIAPISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>100 MG (100 MG, AS NEEDED), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANNABIS (CANNABIS)</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533587-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004029833</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PCO2 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PO2 DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIAPISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>100 MG (100 MG, 1 IN 1 D), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040429</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533588-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200403270</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533589-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040428</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004028884</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>100 MG (AS NEEDED), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL HYDROCHLORIDE (VARDENAFIL HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>20 MG (AS NEEDED), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARDENAFIL HYDROCHLORIDE (VARDENAFIL HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>20 MG (AS NEEDED), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533590-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BR16373</companynumb>
    <primarysource>
      <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>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARLODEL</medicinalproduct>
        <drugbatchnumb>Z0001</drugbatchnumb>
        <drugdosagetext>2.5 MG, ONCE/SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPRESSED LACTATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533591-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03636</companynumb>
    <primarysource>
      <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 TONSILLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARLODEL</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPRESSED LACTATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041204</drugenddate>
        <drugtreatmentduration>7200</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533592-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20040606650</companynumb>
    <primarysource>
      <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>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>HALLUCINATION, AUDITORY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040607</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPRIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEROSPIRONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533593-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20040704586</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANDOSPIRONE CITRATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANDOSPIRONE CITRATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533594-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041200936</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIET REFUSAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOMONTH</medicinalproduct>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMETIDINE</medicinalproduct>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE</medicinalproduct>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOLEUCINE LEUCINE VALINE</medicinalproduct>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNITRAZEPAM</medicinalproduct>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARTATE POTASSIUM</medicinalproduct>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533595-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHRM2004FR03672</companynumb>
    <primarysource>
      <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>BREAST NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARLODEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHALAMO-PITUITARY DISORDERS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970731</drugenddate>
        <drugtreatmentduration>578</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORPROLAC ^NOVARTIS^</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991031</drugenddate>
        <drugtreatmentduration>853</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOSTINEX</medicinalproduct>
        <drugdosagetext>1 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533596-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040309</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004016369</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533597-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004008179</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533598-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004009308</companynumb>
    <primarysource>
      <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>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533599-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004000802</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533600-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200403298</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5036</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>163MG/M3 OTHER-INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533601-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041203956</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533602-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041203</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2003119628</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.8644</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMMUNICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>20895</drugauthorizationnumb>
        <drugdosagetext>100 MG (PRN), ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORDIAZEPOXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533603-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040716</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE02577</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APRAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU DACORTIN H</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTUM</medicinalproduct>
        <drugdosagetext>2 G, BID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMEVEN</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANEF</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCOR</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533604-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200403312</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.9467</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>85MG/M2 Q2W INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040719</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533605-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200403353</companynumb>
    <primarysource>
      <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>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGOSPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533606-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200403361</companynumb>
    <primarysource>
      <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>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533607-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>03P-163-0245661-00</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERIDIA</medicinalproduct>
        <drugauthorizationnumb>20632</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533608-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>04P-163-0254745-00</companynumb>
    <primarysource>
      <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>MERIDIA</medicinalproduct>
        <drugauthorizationnumb>20632</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533609-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNR2004AU01696</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugdosagetext>110 MG IV OVER 24 HOURS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
        <drugtreatmentduration>12960</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALOFALK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
        <drugdosagetext>3 TABLETS TDS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugdosagetext>VISCOUS APPLIED TO TONGUE TWICE DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE</medicinalproduct>
        <drugdosagetext>2 TABLETS BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GTN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTELIN</medicinalproduct>
        <drugdosagetext>1000 UNITS DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugdosagetext>100 MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 G, QID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugdosagetext>400 MG, TID FOR 7 DAYS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533610-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200403399</companynumb>
    <primarysource>
      <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>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>146 MG OTHER INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040825</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533611-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>04P-163-0254757-00</companynumb>
    <primarysource>
      <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>MERIDIA</medicinalproduct>
        <drugauthorizationnumb>20632</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000603</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533612-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>04P-163-0254770-00</companynumb>
    <primarysource>
      <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>MERIDIA</medicinalproduct>
        <drugauthorizationnumb>20632</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533613-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>04P-163-0254891-00</companynumb>
    <primarysource>
      <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>MERIDIA</medicinalproduct>
        <drugauthorizationnumb>20632</drugauthorizationnumb>
        <drugindication>WEIGHT CONTROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020106</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533614-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>04P-163-0259843-00</companynumb>
    <primarysource>
      <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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERIDIA</medicinalproduct>
        <drugauthorizationnumb>20632</drugauthorizationnumb>
        <drugindication>WEIGHT CONTROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533615-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040520</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>04P-163-0261624-00</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERIDIA</medicinalproduct>
        <drugauthorizationnumb>20632</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533616-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>04P-163-0272210-00</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERIDIA</medicinalproduct>
        <drugauthorizationnumb>20632</drugauthorizationnumb>
        <drugdosagetext>PER ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WEIGHT CONTROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533617-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>02P-163-0202392-00</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERIDIA</medicinalproduct>
        <drugauthorizationnumb>20632</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001025</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533618-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12796041</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>AUC=6 THERAPY FROM 18-OCT-2004 TO 18-NOV-2004</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>225 MG/M2 THERAPY FROM 18-OCT-2004 TO 18-NOV-2004</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041118</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533619-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHNU2004DE04166</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGEMINAL NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>PLASMACYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533620-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-12794343</companynumb>
    <primarysource>
      <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>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>DAYS 1-5 EVERY 3-4 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19840923</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>DAYS 1-5 EVERY 3-4 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19840923</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533621-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12798583</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL CHANGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE PILL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugdosagetext>SELF INJECTION DAILY OF FORTEO</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533622-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2004GB14860</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugdosagetext>75 MG/M2, TIW</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
        <drugtreatmentduration>121</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>600 MG/M2, TIW</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
        <drugtreatmentduration>121</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>600 MG, TIW</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040525</drugenddate>
        <drugtreatmentduration>121</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533623-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12794616</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMAUROSIS FUGAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>1ST DOSE ON 01-NOV-2004 OF 400 MG/M2. THEN WEEKLY 250 MG/M2 WEEKLY FOR 7 WEEKS.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533624-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-12794418</companynumb>
    <primarysource>
      <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>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533625-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-12766606</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARCINOEMBRYONIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533626-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12791117</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>39</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTIPSYCHOTIC DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533627-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12795928</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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533628-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12798856</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLUE TOE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  ^1 TO 1 1/2 OF THE REGULAR DOSE^</drugdosagetext>
        <drugindication>BLOOD PRESSURE FLUCTUATION</drugindication>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>DURATION OF THERAPY:  ^FOR A SHORT TIME^</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533629-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-12795746</companynumb>
    <primarysource>
      <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>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TERATOMA</drugindication>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLEOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TERATOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TERATOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TERATOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VP-16</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TERATOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533630-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040702</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0518967A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEEDING TIME ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EROSIVE OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLOP RHYTHM PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM PURULENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOODY HEADACHE POWDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEAD INJURY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BC HEADACHE POWDER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>HEAD INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEAD INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533631-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536291A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
        <drugbatchnumb>3H0602</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533632-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536318A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLORECTAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PIGMENTED NAEVUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ECOTRIN REGULAR STRENGTH TABLETS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533633-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536428A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUTTOCK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMMIT NICOTINE POLACRILEX LOZENGE, 2MG</medicinalproduct>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533634-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536460A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUMS LASTING EFFECTS MINT</medicinalproduct>
        <drugbatchnumb>4B09</drugbatchnumb>
        <drugdosagetext>1TAB SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERUCTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041207</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533635-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536477A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITRUCEL CAPLETS</medicinalproduct>
        <drugbatchnumb>4C11BA</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHANGE OF BOWEL HABIT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugindication>NECK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533636-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536694A</companynumb>
    <primarysource>
      <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>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugdosagetext>4MG TEN TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>TOBACCO ABUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19960101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE (MINT)</medicinalproduct>
        <drugbatchnumb>FE752</drugbatchnumb>
        <drugdosagetext>4MG TEN TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>TOBACCO ABUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COAGULOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533637-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536704A</companynumb>
    <primarysource>
      <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 GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS NON-INSULIN-DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19810101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533638-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536745A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOARSENESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITRUCEL SUGAR-FREE SUSPENSION ORANGE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1TBS PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533639-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536756A</companynumb>
    <primarysource>
      <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>COLLAPSE OF LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>14MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533640-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536905A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ECOTRIN ADULT STRENGTH LOW 81MG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN REGULAR STRENGTH TABLETS</medicinalproduct>
        <drugbatchnumb>4H02</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533641-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536980A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENSODYNE ORIGINAL FLAVOR TOOTHPASTE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19610101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533642-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537028A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITRUCEL SUGAR-FREE SUSPENSION ORANGE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLONIC POLYP</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533643-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200421885GDDC</companynumb>
    <primarysource>
      <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>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19840101</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19840101</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533644-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537511A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533645-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537547A</companynumb>
    <primarysource>
      <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>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL DRYNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MASSENGILL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>IMPAIRED SELF-CARE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MASSENGILL TOWELETTE, UNSCENTED</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>IMPAIRED SELF-CARE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533646-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004/02142</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SONRIDOR</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041127</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533647-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0359215A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DERMOVATE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>CUTANEOUS LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYALONE (JAPAN)</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRENISON</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CUTANEOUS LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533648-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>353236</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>21087</drugauthorizationnumb>
        <drugdosagetext>75 MG    1 PER DAY    ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031127</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533649-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-NOVOPROD-241039</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN SIMPLEXX</medicinalproduct>
        <drugbatchnumb>PU60137</drugbatchnumb>
        <drugdosagetext>.6 MG, QD</drugdosagetext>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533650-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004BE16710</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHERGINE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533651-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040322</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2004GB01531</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE RUPTURE OF MEMBRANES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>125MG QD + 100MG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533652-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>354725</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>21087</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN (MCP)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533653-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>355385</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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>21087</drugauthorizationnumb>
        <drugdosagetext>75 MG    1 PER 2 DAY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040103</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533654-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>355984</companynumb>
    <primarysource>
      <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>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>21087</drugauthorizationnumb>
        <drugdosagetext>75 MG DAILY     ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533655-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>357217</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>21087</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS (ANTIBIOTIC NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533656-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-12798526</companynumb>
    <primarysource>
      <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>EXANTHEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533657-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-BRISTOL-MYERS SQUIBB COMPANY-12800017</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK LEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENDOXAN</medicinalproduct>
        <drugdosagetext>ADMINISTERED ON 16-JAN; 12-FEB; 12-MAR-02</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020312</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>ADMINISTERED ON 16-JAN; 12-FEB; 12-MAR-02</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020312</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>ADMINISTERED ON 16-JAN; 12-FEB; 12-MAR-02</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020312</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPRAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>12.5 MG/20 MG TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BELOC-ZOK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCOUMAR</medicinalproduct>
        <drugdosagetext>TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>ADMINISTERED ON 16-JAN; 12-FEB; 12-MAR-02</drugdosagetext>
        <drugindication>NON-HODGKIN'S LYMPHOMA STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020312</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020310</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533658-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-12766812</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533659-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>358753</companynumb>
    <primarysource>
      <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>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>21087</drugauthorizationnumb>
        <drugdosagetext>25 MG      ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533660-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040324</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>362987</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>21087</drugauthorizationnumb>
        <drugdosagetext>2 PER DAY       ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (ATORVASTATIN)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533661-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041207</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>383201</companynumb>
    <primarysource>
      <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>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>21087</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533662-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00574</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL (ENALAPRIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533663-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00576</companynumb>
    <primarysource>
      <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>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.3 MG/M2, INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533664-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00577</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.30 MG/M2, 1.00 MG/M2   : INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533665-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00605</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533666-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00606</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHINESE HERBS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533667-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00620</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.30 MG/M2 ; 1.00 MG/M2  : IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.30 MG/M2 ; 1.00 MG/M2  : IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL (ENALAPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTEF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533668-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00654</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533669-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00673</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533670-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00676</companynumb>
    <primarysource>
      <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>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>2.00 MG, IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533671-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00683</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>63020-049-01</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533672-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-NOVOPROD-241068</companynumb>
    <primarysource>
      <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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHORIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HORMONE LEVEL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIVELLE</medicinalproduct>
        <drugbatchnumb>PF70395</drugbatchnumb>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533673-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030603</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0411902A</companynumb>
    <primarysource>
      <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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533674-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040819</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0523739A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOMANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF MUTILATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020501</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533675-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040819</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0523745A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD BANGING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPULSIVE BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF MUTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030227</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533676-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0523756A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE MEDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533677-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041021</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0530834A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSKINESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041017</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROBID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN SUPPLEMENTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA AND LEVODOPA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533678-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JPKYO-S-20040035</companynumb>
    <primarysource>
      <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 RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugdosagetext>25MGM2 PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040916</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040911</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533679-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0534877A</companynumb>
    <primarysource>
      <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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGEMINAL NEURALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>875MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533680-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535401A</companynumb>
    <primarysource>
      <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>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533681-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535434A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF LIBIDO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugdosagetext>25MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533682-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535567A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.6</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533683-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0535905A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533684-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DEPFP-S-20040043</companynumb>
    <primarysource>
      <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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</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>GEMCITABINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVOR</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533685-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0536851A</companynumb>
    <primarysource>
      <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>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPZICOM</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXIVA</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533686-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JPKYO-S-20040053</companynumb>
    <primarysource>
      <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>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040927</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URINORM</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIVADIL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOCHU-EKKI-TO</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEZATOL SR</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAIXAN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041031</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533687-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JPKYO-S-20040043</companynumb>
    <primarysource>
      <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>ERYTHROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010329</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533688-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537254A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORNEAL EPITHELIUM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXEDRINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533689-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537281A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533690-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537454A</companynumb>
    <primarysource>
      <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>BLOOD AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533691-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537485A</companynumb>
    <primarysource>
      <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>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533692-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JPKYO-S-20040042</companynumb>
    <primarysource>
      <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>ERYTHROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010717</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010710</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROTONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010710</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010712</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBENIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010703</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010629</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KOLANTYL GEL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010629</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHYTHMY</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010722</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORIZON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010722</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533693-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JPKYO-S-20040041</companynumb>
    <primarysource>
      <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>ERYTHROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugdosagetext>20MGM2 SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011003</drugenddate>
        <drugtreatmentduration>72</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEU-UP</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011020</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010919</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533694-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537602A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533695-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537620A</companynumb>
    <primarysource>
      <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>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR II DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESYREL</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>4533696-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537624A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOOL ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>100MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533697-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537625A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533698-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537660A</companynumb>
    <primarysource>
      <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>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533699-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537695A</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533700-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537700A</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGOHYDRAMNIOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533701-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537700B</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL GROWTH RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGOHYDRAMNIOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533702-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537804A</companynumb>
    <primarysource>
      <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>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533703-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0537806A</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533704-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537916A</companynumb>
    <primarysource>
      <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>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533705-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537923A</companynumb>
    <primarysource>
      <qualification>5</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>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533706-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0537933A</companynumb>
    <primarysource>
      <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>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533707-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0538016A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533708-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0538096A</companynumb>
    <primarysource>
      <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>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020603</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533709-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20010807</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0252993A</companynumb>
    <primarysource>
      <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>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010720</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010720</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533710-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0274108B</companynumb>
    <primarysource>
      <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>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990318</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990318</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NELFINAVIR</medicinalproduct>
        <drugdosagetext>2250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990324</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </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>20010401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533711-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20021120</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0285859A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROXAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOTHIEPIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugdosagetext>7.5MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020902</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533712-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0350187A</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040822</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERENACE</medicinalproduct>
        <drugdosagetext>.375MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040902</drugenddate>
        <drugtreatmentduration>44</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHYPNOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040923</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533713-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0357157A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugdosagetext>250MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPETIC STOMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOTIAM HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LARYNGOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAXIZON</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LARYNGOPHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533714-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004JP001966</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAWACILLIN</medicinalproduct>
        <drugdosagetext>250MG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUTAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN R</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533715-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0358226A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES VIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040803</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040729</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROXAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENTERITIS INFECTIOUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040731</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BAKTAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040812</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPERAZON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEUTROPENIC INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040809</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIKACIN SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEUTROPENIC INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040807</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040806</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRIZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAC B</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYMYXIN B SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040806</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGIZONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040805</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040827</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROTONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040727</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOGLOBINS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040730</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HAPTOGLOBIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIACIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040530</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533716-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0358379A</companynumb>
    <primarysource>
      <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>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HENOCH-SCHONLEIN PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041023</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSLEE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TINELAC</medicinalproduct>
        <drugdosagetext>4UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEILAX</medicinalproduct>
        <drugdosagetext>1MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENIRAN</medicinalproduct>
        <drugdosagetext>2MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANCOLON</medicinalproduct>
        <drugdosagetext>1UNIT THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOFRANIL</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533717-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0358643A</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>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041126</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533718-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0358647A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOLILOQUY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROHYPNOL</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041121</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533719-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0359070A</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>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>200MCG VARIABLE DOSE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KIPRES</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOKUNALIN</medicinalproduct>
        <drugdosagetext>2MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLORIC</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
      </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>DIOVAN</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533720-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-GLAXOSMITHKLINE-B0359142A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </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>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugdosagetext>1ML PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030221</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugdosagetext>2ML PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030221</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>1ML PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030221</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533721-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0359217A</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>1000MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYCOOL</medicinalproduct>
        <drugdosagetext>1500MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</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>NORVASC</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDENALIN</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>.75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROTIZOLAM</medicinalproduct>
        <drugdosagetext>.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESYREL</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533722-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0360264A</companynumb>
    <primarysource>
      <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>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELITREX</medicinalproduct>
        <drugdosagetext>500MG SIX TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES SIMPLEX</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
        <drugdosagetext>75MCG PER DAY</drugdosagetext>
        <drugindication>BIPOLAR I DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugindication>BIPOLAR I DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SURMONTIL</medicinalproduct>
        <drugdosagetext>18DROP PER DAY</drugdosagetext>
        <drugindication>BIPOLAR I DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533723-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-GLAXOSMITHKLINE-B0361120A</companynumb>
    <primarysource>
      <qualification>1</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>HYPERTENSIVE NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL AMYLOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533724-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0361384A</companynumb>
    <primarysource>
      <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>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETIT MAL EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533725-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0361453A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CO-AMOXICLAV</medicinalproduct>
        <drugdosagetext>1.2G UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECOTIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>150MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOPHYLLINE</medicinalproduct>
        <drugdosagetext>225MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533726-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0361628A</companynumb>
    <primarysource>
      <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>ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTUM</medicinalproduct>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041107</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIKLIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041106</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533727-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0361800A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOCET</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMPERAN</medicinalproduct>
        <drugdosagetext>10MG THREE TIMES PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533728-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0361801A</companynumb>
    <primarysource>
      <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>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAMOXYL</medicinalproduct>
        <drugdosagetext>1G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>THREATENED LABOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041205</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533729-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0361810A</companynumb>
    <primarysource>
      <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>APPLICATION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA ASTEATOTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041110</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGADERM DRESSING</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVLOCARDYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASILIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DI ANTALVIC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUNGIZONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SMECTA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIDIA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAG 2</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAFALGAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAYEXALATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533730-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-GLAXOSMITHKLINE-B0361987A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <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 CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020310</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROPRAM</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020331</drugenddate>
        <drugtreatmentduration>89</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CO-RENITEN</medicinalproduct>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>.625MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BELOC ZOK</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCOUMAR</medicinalproduct>
        <drugdosagetext>3MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040312</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020312</drugenddate>
        <drugtreatmentduration>55</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020312</drugenddate>
        <drugtreatmentduration>55</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020312</drugenddate>
        <drugtreatmentduration>55</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533731-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0362036A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041213</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533732-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0362037A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELEVATED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugdosagetext>400MG FIVE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041212</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533733-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0362090A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEROXAT</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROX</medicinalproduct>
        <drugdosagetext>75MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NISIS</medicinalproduct>
        <drugdosagetext>160MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>180MG WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHRONIC HEPATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugdosagetext>2UNIT TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC HEPATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STILNOX</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>1UNIT PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533734-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0362103A</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugdosagetext>600MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040609</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTUM</medicinalproduct>
        <drugdosagetext>1G THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040609</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIPINE HCL</medicinalproduct>
        <drugdosagetext>20MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOMYST</medicinalproduct>
        <drugdosagetext>200MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040507</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533735-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0362228A</companynumb>
    <primarysource>
      <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>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533736-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004-11-1525</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030224</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030224</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030224</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030224</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugdosagetext>40MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030224</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIZIVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030218</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533737-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-GLAXOSMITHKLINE-B0362280A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HBV DNA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPTODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533738-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-GLAXOSMITHKLINE-B0362281A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HBV DNA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPTODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533739-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>115444</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIANI FORTE DISKUS</medicinalproduct>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040816</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>1PUFF PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040806</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>164.5UG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
        <drugtreatmentduration>107</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533740-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041118</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0045288A</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIANI FORTE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugdosagetext>300MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMNIC</medicinalproduct>
        <drugdosagetext>.4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM VERLA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACC</medicinalproduct>
        <drugdosagetext>600MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533741-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>001#1#2004-00250</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATMADISC</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533742-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040708</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-04P-062-0267064-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040602</drugenddate>
        <drugtreatmentduration>104</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESICS</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533743-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040826</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0283253-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>109</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICITIS PERFORATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDIX DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFUZOSIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533744-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-04P-062-0279804-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLACID PRO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1000 MILLIGRAMS ON INITIAL DAY (2 TABS TWICE/DAY), THEN 500 MILLIGRAMS ON FOLLOWING DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLACID PRO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS PLUS</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>LERCANIDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533745-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-04P-163-0283709-00</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</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>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIMATOPROST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533746-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004US16868</companynumb>
    <primarysource>
      <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>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIVALPROEX SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533747-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13326</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DROOLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>0.25 MG, TID</drugdosagetext>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugtreatmentduration>8640</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533748-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13358</companynumb>
    <primarysource>
      <qualification>3</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>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041203</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533749-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US13425</companynumb>
    <primarysource>
      <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>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>100 MG, TID</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041214</drugenddate>
        <drugtreatmentduration>41760</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>100 MG, QID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041214</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533750-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2004JP15796</companynumb>
    <primarysource>
      <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>SKIN NEOPLASM EXCISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA OF SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDREA</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDREA</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930907</drugenddate>
        <drugtreatmentduration>20160</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDREA</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19931003</drugenddate>
        <drugtreatmentduration>37440</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDREA</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19931004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940228</drugenddate>
        <drugtreatmentduration>148</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDREA</medicinalproduct>
        <drugdosagetext>500 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980401</drugenddate>
        <drugtreatmentduration>1493</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN</medicinalproduct>
        <drugdosagetext>30 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020816</drugenddate>
        <drugtreatmentduration>107</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISUMIC</medicinalproduct>
        <drugdosagetext>20 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020816</drugenddate>
        <drugtreatmentduration>191</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOSMIN</medicinalproduct>
        <drugdosagetext>3 G/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEREKINON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020809</drugenddate>
        <drugtreatmentduration>114</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030414</drugenddate>
        <drugtreatmentduration>189</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030526</drugenddate>
        <drugtreatmentduration>60480</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040803</drugenddate>
        <drugtreatmentduration>435</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020417</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533751-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRA 300</medicinalproduct>
        <drugbatchnumb>049942T</drugbatchnumb>
        <drugdosagetext>150 CC</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533752-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081662</companynumb>
    <primarysource>
      <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>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533753-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081669</companynumb>
    <primarysource>
      <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>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/ 2 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533754-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081675</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533755-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081677</companynumb>
    <primarysource>
      <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>CHAPPED LIPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533756-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081682</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF BLOCK IN EAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONE REPLACEMENT THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533757-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081683</companynumb>
    <primarysource>
      <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>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533758-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081691</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG98P</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533759-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081694</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COW'S MILK INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG95S</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/ 1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533760-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081700</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533761-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081703</companynumb>
    <primarysource>
      <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>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533762-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979433</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG IN THE EVENING</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533763-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979436</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00Z</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040926</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTER-C (CALCIUM ASCORBATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533764-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979467</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG99M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 IN THE EVENING</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533765-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979471</companynumb>
    <primarysource>
      <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>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533766-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979473</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533767-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979481</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533768-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979483</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533769-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979495</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533770-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979513</companynumb>
    <primarysource></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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABATRIL (TIAGABINE HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533771-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040979529</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533772-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081567</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041019</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533773-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081569</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</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>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/ 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533774-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081575</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/ 1 DAY</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041015</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533775-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081592</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/ 1 IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN          (GABAPENTIN PFIZER)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZADONE        (TRAZODONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533776-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081600</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533777-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081605</companynumb>
    <primarysource>
      <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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/ 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533778-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081641</companynumb>
    <primarysource>
      <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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INITIAL INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX              (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533779-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081644</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533780-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081650</companynumb>
    <primarysource>
      <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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NARCOTIC PAIN MEDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533781-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081653</companynumb>
    <primarysource>
      <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>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533782-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081445</companynumb>
    <primarysource>
      <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>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN (BURPROPION HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533783-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081447</companynumb>
    <primarysource></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>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7ZH00M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533784-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081448</companynumb>
    <primarysource>
      <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>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533785-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081450</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG/ 1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533786-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081462</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041018</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533787-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081481</companynumb>
    <primarysource>
      <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>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533788-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081541</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SG97W</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR (SIMVASTATIN RATIOPHARM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533789-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081544</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533790-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081562</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>7SH00M</drugbatchnumb>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>30 MG DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRUCEL (METHYLCELLULOSE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE W/IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533791-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041206</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041081564</companynumb>
    <primarysource>
      <qualification>1</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>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>21427</drugauthorizationnumb>
        <drugdosagetext>60 MG/ 1 DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533792-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0407104467</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENILE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>8EA52M</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533793-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0407104492</companynumb>
    <primarysource>
      <qualification>1</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>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533794-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0408104680</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>10 MG AS NEEDD</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533795-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0408104719</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>8EA31A</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>8EA31A</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMCITAL (LAMOTRIGINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COD-LIVER OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CREATINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533796-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0408104812</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533797-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040603</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0406USA00672</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>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARIET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSCOPAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040508</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533798-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0412GBR00084</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORIDE HYDROCHLORIDE AND FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533799-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01972</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533800-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0408104821</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.5244</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>8EA45M</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>0.05 DSG FORM</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED ACID BLOCKER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533801-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041119</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03428</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533802-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0412USA02058</companynumb>
    <primarysource>
      <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>ANGIONEUROTIC OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533803-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01999</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEBETA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533804-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0408104927</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533805-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MERCK-0410USA03499</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</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>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041009</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRUFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533806-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01579</companynumb>
    <primarysource>
      <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>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041215</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533807-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0408104942</companynumb>
    <primarysource>
      <qualification>1</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>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533808-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040211</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0408104959</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCOMMODATION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533809-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040211</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0408104960</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCOMMODATION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533810-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040707</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0407USA00560</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTITHROMBIN III DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE 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>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID BRUIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ATHEROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCOAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBIN BLOOD PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020728</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533811-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0412FRA00053</companynumb>
    <primarysource>
      <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>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENFLUOREX HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELMISARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYGEUM AFRICANUM EXTRACT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533812-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PH-MERCK-0410PHL00002</companynumb>
    <primarysource>
      <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>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIUS FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRACETAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533813-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0301USA03199</companynumb>
    <primarysource>
      <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>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUSOPT</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAXOLOL OPHTHALMIC SOLUTION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITONIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EXOSTOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030707</drugenddate>
        <drugtreatmentduration>1680</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030707</drugenddate>
        <drugtreatmentduration>1284</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSYLLIUM HUSK</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533814-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MERCK-0411FRA00058</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041008</drugenddate>
        <drugtreatmentduration>100</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBIMAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
        <drugtreatmentduration>104</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOTEROL HYDROBROMIDE AND IPRATROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN ALFA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533815-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA00871</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COSTOCHONDRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
        <drugtreatmentduration>81</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533816-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040909</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CM-MERCK-0409USA00597</companynumb>
    <primarysource>
      <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>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533817-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MERCK-0410GBR00244</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALE PATTERN BALDNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533818-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0306USA00865</companynumb>
    <primarysource>
      <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>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE REDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOLARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERFICIAL INJURY OF EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MONARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533819-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01532</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021011</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533820-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA00705</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533821-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041018</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA02613</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533822-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01601</companynumb>
    <primarysource>
      <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>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCOLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533823-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0411USA03574</companynumb>
    <primarysource>
      <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>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19790101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533824-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00144</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533825-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA03146</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>123</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTICOAGULANT THERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITEK</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533826-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041014</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA02220</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOCHONDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533827-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01536</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533828-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01612</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533829-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA02009</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533830-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01862</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533831-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01944</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIORIDAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELLARIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORCET-HD</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HYCLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533832-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01770</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533833-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA02008</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY BLADDER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533834-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01859</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533835-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01936</companynumb>
    <primarysource>
      <qualification>2</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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533836-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01929</companynumb>
    <primarysource>
      <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>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533837-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01945</companynumb>
    <primarysource>
      <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>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELENZEPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIDEPRESSANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533838-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080707</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>8EA32S</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533839-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080714</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>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSTADA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533840-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080743</companynumb>
    <primarysource>
      <qualification>1</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>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533841-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080751</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>8EA44M</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533842-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA02010</companynumb>
    <primarysource>
      <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>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533843-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-MERCK-0412CHE00021</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040920</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533844-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080756</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>8EA44M</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533845-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA02192</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000107</drugenddate>
        <drugtreatmentduration>199</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533846-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080759</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>136</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>8EA49R</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>10 MG/1</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRN (ACETYLSALICYLIC ACID)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533847-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080901</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</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>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533848-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-MERCK-0412POL00004</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>35</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>FUNGAL PERITONITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041129</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIEMETIC SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE SODIUM TETRAHYDROPHTHALATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANCOTIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041125</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit></drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533849-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MERCK-0412DEU00131</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COMA HEPATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533850-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA01864</companynumb>
    <primarysource>
      <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>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030814</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533851-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080962</companynumb>
    <primarysource>
      <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>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROXATRAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533852-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0401100184</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>7EH72A</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533853-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040903</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0406103456</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533854-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080440</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533855-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080480</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533856-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080483</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>8EA44M</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533857-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080500</companynumb>
    <primarysource>
      <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533858-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080538</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRIAPISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533859-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080553</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533860-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080609</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>7EH36B</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041007</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533861-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080627</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>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>0.5 DSG FORM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX MR (TAMSULOSIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533862-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080658</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>8EA30A</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED HYPERTENSION MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533863-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0412USA02184</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENTRICULAR DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533864-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080673</companynumb>
    <primarysource></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>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533865-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105466</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533866-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105471</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>10 MG AS NEEDED</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533867-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20010927</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-01093165</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL DEFORMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533868-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-0410USA01957</companynumb>
    <primarysource>
      <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>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533869-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105475</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>7EH35A</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG AS NEEDED</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BABY ASPIRIN (ACETYLSALCYLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS NOS (MULTIVITAMINS NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533870-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105687</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>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533871-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105720</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SPONTANEOUS PENILE ERECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG AS NEEDED</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533872-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105726</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040915</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533873-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105902</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>ANAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533874-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105959</companynumb>
    <primarysource>
      <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>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533875-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409106109</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG/1 DAY</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533876-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409106113</companynumb>
    <primarysource></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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG AS NEEDED</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED BETA-BLOCKER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533877-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-0409105321</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>134</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG AS NEEDED</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL (CAPTOPRIL BIOCHEMIE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELI-ON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533878-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040903</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105351</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533879-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105353</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533880-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040903</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105369</companynumb>
    <primarysource>
      <qualification>1</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>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533881-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040903</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105371</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>BEA30A</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533882-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105375</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>7EH70A</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>10 MG AS NEEDED</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533883-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105376</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG AS NEEDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040903</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533884-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105377</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>10 MG AS NEEDED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533885-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105380</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533886-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105451</companynumb>
    <primarysource>
      <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>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533887-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0408105024</companynumb>
    <primarysource>
      <qualification>1</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>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533888-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0408105025</companynumb>
    <primarysource>
      <qualification>1</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>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533889-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0408105027</companynumb>
    <primarysource>
      <qualification>1</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>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533890-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0408105032</companynumb>
    <primarysource>
      <qualification>1</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>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533891-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105114</companynumb>
    <primarysource>
      <qualification>1</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>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533892-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105115</companynumb>
    <primarysource>
      <qualification>1</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>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533893-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105246</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALE ORGASMIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533894-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105248</companynumb>
    <primarysource>
      <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>PAINFUL ERECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533895-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0409105275</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS NOS (MULTIVITAMIN NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533896-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040211</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0408104962</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCOMMODATION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533897-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040211</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0408104963</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCOMMODATION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533898-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040211</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0408104964</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCOMMODATION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533899-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040211</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0408104966</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCOMMODATION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533900-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040211</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0408104968</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCOMMODATION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533901-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040211</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0408104969</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCOMMODATION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533902-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0408104973</companynumb>
    <primarysource></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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG AS NEEDED</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN (ATENOLOL EG)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533903-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0408104976</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG AS NEEDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533904-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0408104977</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>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>10 MG AS NEEDED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533905-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US_0408105013</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.6996</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>8EA44M</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533906-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>356390</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugauthorizationnumb>13263</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL (FENTANYL CITRATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE (PAROXETINE)</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE (PROPOXYPHENE HYDROCHLORIDE)</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533907-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>357907</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugauthorizationnumb>13263</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC (ENALAPRILUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533910-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041202</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>269121</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugauthorizationnumb>13263</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19780615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM (LITHIUM NOS)</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533911-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200403451</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>136.9863</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>260 MG OTHER - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLASETRON MESILATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533912-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200303011</companynumb>
    <primarysource>
      <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>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>100 MG/M2 OTHER - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533913-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200400407</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.3993</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO LUNG</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533914-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040519</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200401629</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>150 MG OTHER - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533915-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040521</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200401647</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.2971</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>150 MG Q2W - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PALONOSETRON HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533916-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040608</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200401828</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94.3482</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>479731</drugbatchnumb>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>145 MG Q2W - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>036</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>479752</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533917-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200402365</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.3419</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>200 MG OTHER - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533918-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>A03200402544</companynumb>
    <primarysource>
      <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>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>615575</drugbatchnumb>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>197 MG Q2W - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLASETRON MESILATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533919-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>F03200400085</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugauthorizationnumb>21492</drugauthorizationnumb>
        <drugdosagetext>171 MG OTHER  - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>804 MG FOLLOWED BY 1206 MG CONTINUOUS INFUSION - INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>INTRAVENOUS NOS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533920-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00698</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533921-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00706</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.30 MG/M2 , 2/WEEK INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533922-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00714</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASMACYTOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.80 MG IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT (ERYTHROPOIETIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533923-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00717</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533924-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00743</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.30 MG/M2 IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533925-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00746</companynumb>
    <primarysource>
      <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>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.30 MG/M2  IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533926-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00760</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533927-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00761</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533928-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00772</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533929-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00791</companynumb>
    <primarysource>
      <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>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.80 MG, IV BOLUS   : IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugdosagetext>1.80 MG, IV BOLUS   : IV BOLUS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533930-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00796</companynumb>
    <primarysource>
      <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>DYSPNOEA</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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE(THALIDOMIDE) TABLET</medicinalproduct>
        <drugdosagetext>100.00 MG , ORAL :  50.00 MG, ORAL : 100.00 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE(THALIDOMIDE) TABLET</medicinalproduct>
        <drugdosagetext>100.00 MG , ORAL :  50.00 MG, ORAL : 100.00 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533931-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00797</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533932-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041210</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004-00798</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533933-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>22011M02USA</companynumb>
    <primarysource>
      <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>HYPOTHALAMO-PITUITARY DISORDERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAIZEN</medicinalproduct>
        <drugauthorizationnumb>19764</drugauthorizationnumb>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533936-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031029</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>200313366GDS</companynumb>
    <primarysource>
      <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>LARGE INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugauthorizationnumb>20499</drugauthorizationnumb>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533937-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041208</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004UW24254</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533938-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040814</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>S04-USA-04369-01</companynumb>
    <primarysource>
      <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>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>150 MG QD</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533939-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>S04-USA-03012-01</companynumb>
    <primarysource>
      <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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</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>20040218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>300 MG BID PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533940-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>S04-USA-01391-01</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.6579</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugbatchnumb>010360</drugbatchnumb>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040303</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533941-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>S04-USA-07134-01</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LACERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>5 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533942-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>S04-USA-07142-01</companynumb>
    <primarysource>
      <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>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE</medicinalproduct>
        <drugdosagetext>30 TABLET ONCE PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041025</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533943-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JSJ 001</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.1417</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE BURNING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE VESICLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY NON-RESPONDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UMECTA EMULSION</medicinalproduct>
        <drugbatchnumb>F403001</drugbatchnumb>
        <drugdosagetext>APPLY SMALL AMOUNT TOPICALLY TO FOOT DAILY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRY SKIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNITHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533944-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040806</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1002349</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5755</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugbatchnumb>3L1149</drugbatchnumb>
        <drugauthorizationnumb>74732</drugauthorizationnumb>
        <drugdosagetext>20MG QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugbatchnumb>3L1149</drugbatchnumb>
        <drugauthorizationnumb>74732</drugauthorizationnumb>
        <drugdosagetext>20MG QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533945-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1003019</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>25 MG/DAY, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533946-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041012</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1003059</companynumb>
    <primarysource>
      <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>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHANGE OF BOWEL HABIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>75491</drugauthorizationnumb>
        <drugdosagetext>75 MG TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533947-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1003239</companynumb>
    <primarysource></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</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040609</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533948-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1003291</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTENDED PHENYTOIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533949-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2004S1003599</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>75417</drugauthorizationnumb>
        <drugdosagetext>100 MG BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041026</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACARBOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN LISPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533950-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1764</companynumb>
    <primarysource>
      <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>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>74949</drugauthorizationnumb>
        <drugdosagetext>50-300MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533951-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1762</companynumb>
    <primarysource>
      <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>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>74949</drugauthorizationnumb>
        <drugdosagetext>15-200 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>74949</drugauthorizationnumb>
        <drugdosagetext>15-200 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533952-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>04-12-1758</companynumb>
    <primarysource>
      <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>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>74949</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533953-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>000#8#2004-00780</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OPERATIVE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE, SOLUTION (GLYCERYL TRINITRATE)</medicinalproduct>
        <drugauthorizationnumb>18537</drugauthorizationnumb>
        <drugdosagetext>1 MICROGRAM/KG/MIN</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>TOCOLYSIS</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugdosagetext>BETWEEN 1.9% AND 4% IN OXYGEN-AIR</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIOPENTAL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFENTANIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCCINYLCHOLINE CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VECURONIUM (VECURONIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533954-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>000#8#2004-00781</companynumb>
    <primarysource></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>OPERATIVE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYCERYL TRINITRATE, SOLUTION (GLYCERYL TRINITRATE)</medicinalproduct>
        <drugauthorizationnumb>18537</drugauthorizationnumb>
        <drugdosagetext>1 MICROGRAM/KG/MIN</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>TOCOLYSIS</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugdosagetext>BETWEEN 1.8% AND 3.5% IN OXYGEN-AIR</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIOPENTAL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCCINYLCHOLINE CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VECURONIUM (VECURONIUM)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533955-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.905</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>100MG AM 100MG PM ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533956-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.9572</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB  100MG/5CC  IMCLONE</medicinalproduct>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN   85MG/M2  SANOFI-SYNTHELABO</medicinalproduct>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533957-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>100MG/M2   Q3 WEEKS  INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>100MG/M2   Q3 WEEKS  INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANZEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE 0.9%</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXICET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533958-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARITAL PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPLY SLEEP   25MG  TYLENOL</medicinalproduct>
        <drugdosagetext>2 CAPLETS  AT BEDTIME ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533959-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.7403</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>1EVERY OTHER D ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040929</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533960-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2356</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>250MG  DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041219</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533961-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.3273</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORGASM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YAWNING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugdosagetext>60MG  ONCE DAILY ORAL  AM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533962-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.0396</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>1 A DAY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533963-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE N 100/APAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN (NIASPAN-KOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNISOLIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL 90/IPTRATROP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533964-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>119.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORZOLAMIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE 5MG/METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRIMONIDINE TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPROMELLOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PILOCARPINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPROMELLOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVOPROST</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533965-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THREAT OF REDUNDANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCTREOTIDE ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533966-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>ACINETOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSFUSION REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIKIN</medicinalproduct>
        <drugdosagetext>INTRAVENOUS; 1000.0</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>WOUND INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYMIXIN B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533967-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS  MFD BY GLAXOSMITHKLINE</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533968-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTRIGLYCERIDAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>ORAL; 20.0 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533969-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM CAP, SA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE CAP, SA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNISOLIDE (AEROBID) INHALANT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACITRACIN-POLYMIXIN B OINT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL/IPRATROPIUM MDI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACITRACIN / POLYMIXIN OINT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL/IPRATROPIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533970-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.3795</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugbatchnumb>451612N</drugbatchnumb>
        <drugdosagetext>TOOK 1 TABLET A DAY</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533975-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>GM7913</drugbatchnumb>
        <drugdosagetext>20 MG PO DAILY</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041017</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4533999-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</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>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>86 MG 1 Q WK IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>199 MG 1 Q WEEK  IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OSI-774</medicinalproduct>
        <drugdosagetext>150 MG 1 Q DAY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040812</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534005-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORAL HYDRATE SYRUP, USP, 500 MG/5 ML, MGP PRODUCT CODE: 8533</medicinalproduct>
        <drugbatchnumb>26640A</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534007-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.3</patientweight>
      <patientsex>1</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>60 MG/M2  /WEEK * 3</drugdosagetext>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>60 MG/M2  /WEEK * 3</drugdosagetext>
        <drugindication>NEOPLASM RECURRENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>60 MG/M2  /WEEK * 3</drugdosagetext>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>60 MG/M2  /WEEK * 3</drugdosagetext>
        <drugindication>NEOPLASM RECURRENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>60 MG/M2  /WEEK * 3</drugdosagetext>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>60 MG/M2  /WEEK * 3</drugdosagetext>
        <drugindication>NEOPLASM RECURRENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISTARIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TPN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534012-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>GP0103</drugbatchnumb>
        <drugdosagetext>1 CAP QD AS DIRECTED</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041217</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534013-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>GP5657</drugbatchnumb>
        <drugdosagetext>20MG CAPSULE DAILY  (WAS ON PRILOSEC FOR APPROX 2 YEARS)</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534016-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>GP5665</drugbatchnumb>
        <drugdosagetext>1 CAPSULE DAILY  (STARTED GENERIC 10 DAYS AGO)</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VAGIFEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRATEST H.S.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534018-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>GP5662</drugbatchnumb>
        <drugdosagetext>1 CAPSULE BY MOUTH DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534019-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POLYETHYLENE GLYCOL 3350 PWD 527G;</medicinalproduct>
        <drugdosagetext>MIX AND TAKE 1 TABLESPOONFUL IN 8 OUNCES OF WATER DAILY</drugdosagetext>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534022-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>107.9561</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOOL ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugbatchnumb>Y41859</drugbatchnumb>
        <drugdosagetext>1.5 TABLETS BY MOUTH TWICE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534025-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080097</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>7EH80M</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG DAY</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534027-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7194</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugdosagetext>1 PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010813</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534028-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080101</companynumb>
    <primarysource>
      <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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG DAY</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534029-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.8957</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PTU    NOT KNOWN   NOT KNOWN</medicinalproduct>
        <drugindication>HYPERTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041204</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534032-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>26.0818</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>300 MG  ONCE AT BEDTIM     ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534035-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040930</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534039-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413612JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ANTIEMETIC SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ANTIEMETIC SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEU-UP</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NEUTROPHIL COUNT DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040922</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534040-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041007</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200417665US</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>39</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QRS COMPLEX PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: AUC 6</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugbatchnumb>X200632</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: WITH CHEMO; UNKNOWN DOSE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534042-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413862JP</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534043-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413405EU</companynumb>
    <primarysource>
      <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>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIGROTONA</medicinalproduct>
        <drugdosagetext>DOSE UNIT: CUP</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFENO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRISDAL</medicinalproduct>
        <drugdosagetext>DOSE UNIT: CUP</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534044-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080138</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONTANEOUS PENILE ERECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>7EH05A</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534045-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>1 TABLET   EVERYDAY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041210</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534046-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080152</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG DAY</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534047-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9154</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugdosagetext>ONE   PER DAY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENTRICULAR TACHYCARDIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534048-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080162</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG DAY</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534049-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080172</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG DAY</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534050-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080176</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>EA49R</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534051-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.978</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugdosagetext>400MG   Q24HR   INTRAVENOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPENEX,</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUMEGA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534052-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041220</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.1626</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUMEGA</medicinalproduct>
        <drugdosagetext>50 MCG/KG    DAILY   SUBCUTANEO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUMEGA</medicinalproduct>
        <drugdosagetext>50 MCG/KG    DAILY   SUBCUTANEO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOCYTOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAYEXALATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESYREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534053-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>11.3399</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugdosagetext>0.63 VIAL    EVERY 4-6 HOUR   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugdosagetext>0.63 VIAL    EVERY 4-6 HOUR   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041211</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534054-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.1428</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>2 AM    3 PM    ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THORAZINE</medicinalproduct>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534055-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080179</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG DAY</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534056-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</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>INSULIN NPH HUMAN 100 U/ML INJ NOVOLIN N</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534057-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE 2% CREAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534058-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080379</companynumb>
    <primarysource>
      <qualification>1</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>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534059-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA041080404</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE (RAMIPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS NOS (MULTIVITAMINS NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534060-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL AND ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE 30/ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534062-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876835</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXERCISE TOLERANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534063-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERAZOSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534064-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534065-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876838</companynumb>
    <primarysource>
      <qualification>1</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>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534067-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876858</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZADONE (TRAZODONE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN (ACETYLSALCYLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAPIN (CLONAZEPAM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534068-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876873</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534069-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABSORBASE TOP OINT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534070-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876883</companynumb>
    <primarysource></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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>EH11A</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534071-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876898</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534072-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876941</companynumb>
    <primarysource>
      <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>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>8EA37A</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>SEXUAL DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040828</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534074-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876974</companynumb>
    <primarysource></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>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED HIGH BLOOD PRESSURE MEDICINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534075-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE 5MG/ACETAMINOPHEN 325MG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534076-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876983</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORGASM ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>8EA33M</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG/1 DAY</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534077-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HCTZ 25/TRIAMTERENE 37.5MG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534078-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876989</companynumb>
    <primarysource></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>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534079-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041202542</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BI-PROFENID</medicinalproduct>
        <drugdosagetext>3 QD</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKENAN</medicinalproduct>
        <drugdosagetext>70 BID</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>20 QID</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLIPRANE</medicinalproduct>
        <drugdosagetext>4 QD</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534080-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20041202887</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEGIONELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534081-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20041202899</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534082-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20041202943</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</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>DICLOFENAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534083-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041203231</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>30</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION PARASITIC</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>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534084-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041203289</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>THE PATIENT HAS RECEIVED REMICADE FOR 2 YEARS.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534085-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041203542</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE REPAIR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534086-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041203995</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</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>VALIUM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVSIN PB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LONOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LONOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534087-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041105360</companynumb>
    <primarysource>
      <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>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugdosagetext>100-650 MG TABLETS, 1 PO Q 4-6 HOURS PRN PAIN</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>AT HS</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B-50</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRO-K</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGA MULTIPLE/CHELATED MINERAL TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534088-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HCTZ 25/TRIAMTERENE 37.5MG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534089-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20040602790</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>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534090-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20041106278</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIA SPUTUM IDENTIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOALVEOLAR LAVAGE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION PSEUDOMONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARVOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY MONILIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENOTROPHOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>3RMKA727;03A052</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugbatchnumb>3RMKA727;03A052</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN 50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STANGYL 25</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534091-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20040706485</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>4TH ADMINISTRATION</drugdosagetext>
        <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>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDONIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIMATIL</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYOTEC</medicinalproduct>
        <drugdosagetext>(200)</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FARNEZONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERASTAR</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STICKZENOL A</medicinalproduct>
        <drugdosagetext>ADMIN. ROUTE: LINIMENT</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUVENYL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SP TROACHES</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMEDIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMEDIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMEDIN</medicinalproduct>
        <drugdosagetext>6 CAP (3X) PER DAY</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEREKINON</medicinalproduct>
        <drugdosagetext>(100)</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA CA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>PROMOTION OF PERIPHERAL CIRCULATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
        <drugdosagetext>(0.5)</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAL</medicinalproduct>
        <drugdosagetext>(20)</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EURODIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534092-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20041002958</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NECROTISING FASCIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTANCYL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALEROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534093-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041006963</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIUM AVIUM COMPLEX 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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INH</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIAMIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONALON</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534094-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040809518</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.99</patientweight>
      <patientsex>2</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>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534095-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040400709</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>121.11</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534096-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041210</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041006348</companynumb>
    <primarysource>
      <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>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534097-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041111</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20041106060</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHINGOID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</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>049</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRENOCORTICAL HORMONE</medicinalproduct>
        <drugdosagetext>HAS BEEN OB FOR 13 YEARS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENET</medicinalproduct>
        <drugdosagetext>1 DOSE= 1 TABLET</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>1 DOSE= 1 TABLET</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTELUC</medicinalproduct>
        <drugdosagetext>1 DOSE= 1 TABLET</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSSEN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVER</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534098-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041211</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20040900928</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS CARINII 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>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugdosagetext>2 T PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>1T PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINORIL</medicinalproduct>
        <drugdosagetext>3 T PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534099-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>118.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE 2.5MG/METFORMIN HCL  500MG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534102-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM (INWOOD)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL NA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534103-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>110.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534104-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>110.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERAZOSIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534105-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534109-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876625</companynumb>
    <primarysource></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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>7EH71A</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534111-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040827</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876666</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL    /USA/(PARACETAMOL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534115-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040827</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876714</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG AS NEEDED</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534116-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040827</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876720</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>8EA44M</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534119-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040827</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876738</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534122-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040827</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876739</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534123-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>25 MG/M2</drugdosagetext>
        <drugindication>OESOPHAGEAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN</medicinalproduct>
        <drugdosagetext>500MG/M2</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUDR</medicinalproduct>
        <drugdosagetext>120MG/KG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXI (ILLEGIBLE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZERTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534124-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040827</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876740</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANORGASMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>8EA32S</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX (ALPRAZOLAM DUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534125-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.1532</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCARDIA</medicinalproduct>
        <drugdosagetext>60 G ONCE DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534126-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876769</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOSPERMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534127-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040827</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876797</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>8EA32M</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534128-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51.7101</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>1125MG/M2 (IV) ON 3 WEEKS; OFF 1 WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SUSTAINED RELEASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534130-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040876815</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534135-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004UW24566</companynumb>
    <primarysource>
      <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>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>21366</drugauthorizationnumb>
        <drugdosagetext>10 MG DAILY PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534136-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <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>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>4POAM, 3PONOON + 4POHS</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534140-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040670355</companynumb>
    <primarysource>
      <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>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX MR (TAMSULOSIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534143-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040806</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040671059</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534145-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040506</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20040501045</companynumb>
    <primarysource>
      <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>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugbatchnumb>HPF037</drugbatchnumb>
        <drugauthorizationnumb>20958</drugauthorizationnumb>
        <drugdosagetext>  , 1 IN 1 TOTAL, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040504</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534148-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040671274</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>109</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534150-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>PHEH2004US12131</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>19.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOCALIN</medicinalproduct>
        <drugauthorizationnumb>21278</drugauthorizationnumb>
        <drugdosagetext>5 MG, BID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041109</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534152-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.978</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>ROTATOR CUFF SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534153-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040806</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040671414</companynumb>
    <primarysource>
      <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>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534155-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040701</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040771642</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534156-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH SCALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugdosagetext>PER AGE</drugdosagetext>
        <drugindication>PYREXIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534157-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>358749</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>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TICLID</medicinalproduct>
        <drugauthorizationnumb>19979</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534158-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040771701</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF LIBIDO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG AS NEEDED</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX (GUAIFENESIN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX MR (TAMSULOSIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534159-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.318</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugdosagetext>153MG IV</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>5040MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN  720MG  BEDFORD</medicinalproduct>
        <drugdosagetext>720MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534160-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>359258</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH SCALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BLEEDING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TICLID</medicinalproduct>
        <drugauthorizationnumb>19979</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534161-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040772063</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>40 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534162-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>80MG PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASCITES</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534163-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040772209</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040702</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534164-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040708</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>373679</companynumb>
    <primarysource>
      <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>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TICLID</medicinalproduct>
        <drugauthorizationnumb>19979</drugauthorizationnumb>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TNKASE</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>DRUG USE FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534165-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040772353</companynumb>
    <primarysource>
      <qualification>3</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>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>7EH36A</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVATAN (TRAVOPROST)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E (HERBAL OIL NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBERCON (POLYCARBOPHIL CALCIUM)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCUVITE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPERCREME (TROLAMINE SALICYLATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534166-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.1939</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugbatchnumb>ZZP1276</drugbatchnumb>
        <drugdosagetext>200 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR II DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugbatchnumb>ZZP1276</drugbatchnumb>
        <drugdosagetext>200 MG QD PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041214</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534167-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040772520</companynumb>
    <primarysource>
      <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>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20MG</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YOHIMBINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARGININE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BESTER COMPLEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534168-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004233287US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugindication>PROSTATIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534169-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.2658</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugbatchnumb>0596229-04854</drugbatchnumb>
        <drugdosagetext>800/160   2 TIMES A DAY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SKIN DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041203</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534170-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004233399US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>TID, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OTHER ANTIHYPERTENSIVES()</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534171-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004233447US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN LOWER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534172-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43.5453</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BILE DUCT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>ONE  DAILY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041114</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534174-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040875746</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534176-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.6683</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARKEDLY REDUCED DIETARY INTAKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMFED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534177-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004233520US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534179-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040875749</companynumb>
    <primarysource></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>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>7EH16A</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534180-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004233525US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534181-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>300 MGS  TWICE A DAY  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>90 MGS   NIGHT   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031216</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534183-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004233542US</companynumb>
    <primarysource>
      <qualification>5</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>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534184-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.9572</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB  100MG/ 5CC  IMCLONE</medicinalproduct>
        <drugbatchnumb>03C00824A</drugbatchnumb>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN   85MG/M2  SANOFI-SYNTHELABO</medicinalproduct>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041116</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534185-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040905</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004233558US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534186-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20020812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>C-04-0006</companynumb>
    <primarysource>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>17.6903</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugauthorizationnumb>87953</drugauthorizationnumb>
        <drugdosagetext>ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020325</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534187-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040903</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004233569US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534188-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.8957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLAT AFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>50 MG   3X A DAY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>50 MG   3X A DAY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041215</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534190-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040903</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004233591US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 + 20 QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040822</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 + 20 QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET (OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534193-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040903</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004233933US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>25 MG, PRN, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIA 1/35E-21</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIGAMOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPCON-A</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534194-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.3899</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GATIFLOXACIN</medicinalproduct>
        <drugdosagetext>200 MG   ONCE DAILY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534195-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040875758</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>8EA43M</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534197-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004232445US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534198-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040875759</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534199-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004232485US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA INFECTIOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG BID</drugdosagetext>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040829</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534200-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041213</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20031219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>354699</companynumb>
    <primarysource>
      <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>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>FORTOVASE</medicinalproduct>
        <drugauthorizationnumb>20828</drugauthorizationnumb>
        <drugdosagetext>800 MG DAILY ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</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>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NELFINAVIR (NELFINAVIR)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534201-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004232492US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534202-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugbatchnumb>35560</drugbatchnumb>
        <drugdosagetext>50-100MG  QID  AURICULAR</drugdosagetext>
        <drugadministrationroute>001</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534203-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004232899US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>145.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SWELLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040827</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534204-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19970326</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SOLVAY-PANC003970006</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24480</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>42.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MINERAL METABOLISM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 100 ML. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPOALBUMINAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19961206</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 100 ML. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19961227</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 100 ML. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970110</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 100 ML. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970118</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 100 ML. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970129</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 100 ML. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970221</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 100 MILLILITRE(S)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CREON</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 3 G. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATITIS CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970320</drugenddate>
        <drugtreatmentduration>120</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLITA-T NO.3</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 500 ML. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970129</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORIPRON F</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 300 ML. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970129</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOLAMIN MULTI</medicinalproduct>
        <drugdosagetext>DAILY DOSE: UNK. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970129</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>P-N TWIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 1000 ML. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970319</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTRALIPOS</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 200 ML. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970130</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTRALIPOS</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 100 ML. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970313</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 20 ML. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 20 ML. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970319</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELEMENMIC</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 1 DF. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970312</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FESIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 1 DF. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970319</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>5% GLUCOSE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 20 MILLILITRE(S)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970317</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534205-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040422</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SOLVAY-00304001145</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21341</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>39</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD AMYLASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOUGHMAC E</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 3 DF. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPIGASTRIC DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980224</drugenddate>
        <drugtreatmentduration>229</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CREON</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 3 G. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALIGNANT NEOPLASM OF AMPULLA OF VATER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980709</drugenddate>
        <drugtreatmentduration>364</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 45 ML. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970901</drugenddate>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 9 INTERNATIONAL UNIT(S)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980709</drugenddate>
        <drugtreatmentduration>364</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 2 IU. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980709</drugenddate>
        <drugtreatmentduration>364</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 1 DF. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19971125</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPEMIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 1 DF. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980709</drugenddate>
        <drugtreatmentduration>283</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOTIAM HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 2 G. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980118</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534206-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19970904</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SOLVAY-PANC003970012</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24385</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <patientdeath>
        <patientdeathdateformat></patientdeathdateformat>
        <patientdeathdate></patientdeathdate>
      </patientdeath>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSOSAN</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 150 MG. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHOLESTASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19971010</drugenddate>
        <drugtreatmentduration>347</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CREON</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 3 G. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970828</drugenddate>
        <drugtreatmentduration>280</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACENALIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 15 MG. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19971010</drugenddate>
        <drugtreatmentduration>368</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIO THREE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 3 G. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19971010</drugenddate>
        <drugtreatmentduration>375</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UFT</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 300 MG. FREQUENCY:UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19971207</drugenddate>
        <drugtreatmentduration>115</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970828</drugenddate>
        <drugtreatmentduration>252</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534207-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040875766</companynumb>
    <primarysource></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>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORGASMIC SENSATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>10 MG AS NEEDED</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534208-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20041205340</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534209-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SOLVAY-00204004081</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26796</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>97</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 30 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COVERSYL</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 4 MILLIGRAM(S)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>377</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED THERAPY [PERINDOPRIL VS PLACEBO]</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 2 DOSAGE FORM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041018</drugenddate>
        <drugtreatmentduration>834</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROXIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAHISTINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE:  UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534210-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.4619</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERAZOSIN   5MG</medicinalproduct>
        <drugdosagetext>5MG   QHS   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN LISPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHRO-VITE RX TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVELAMER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAPROTERENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPROSTADIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HCTZ 12.5/IRBESARTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534212-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040875792</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>8EA33M</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAX SEED OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORAL CALCIUM DAILY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAYENNE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>Q-GEL PLUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAW PALMETTO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534213-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004232999US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOARSENESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534214-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6475</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>1 QD</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534215-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004233011US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTOSE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED BLOOD PRESSURE PILL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534216-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102.0593</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARMACEUTICAL PRODUCT COMPLAINT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE   137MCG   CVS PYARMACY</medicinalproduct>
        <drugdosagetext>1 PILL   ONCE A DAY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041217</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534218-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040828</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004233099US</companynumb>
    <primarysource>
      <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 INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE W/CHONDROITIN SULFATES (MANGANESE)</medicinalproduct>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534219-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.6683</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>1 TABLET DAILY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041123</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534222-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004233113US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugindication>MONARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534223-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7716</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRO XR</medicinalproduct>
        <drugdosagetext>2 PER DAY   ORAL TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534224-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004233188US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS (MAGNESIUM CARBONATE, MAGNESIUM TRISILICATE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534225-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60MG  1 QD  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60MG  1 QD  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60MG  1 QD  ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041022</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534226-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>24.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETAMINE HCL</medicinalproduct>
        <drugbatchnumb>581G01500763M</drugbatchnumb>
        <drugdosagetext>1MG/KG   1 TIME   INTRAVENOU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATIVE THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETAMINE HCL</medicinalproduct>
        <drugbatchnumb>581G01500763M</drugbatchnumb>
        <drugdosagetext>1MG/KG   1 TIME   INTRAVENOU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>THERAPEUTIC PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugdosagetext>0.01MG/KG   1 TIME   INTRAVENOU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATIVE THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugdosagetext>0.01MG/KG   1 TIME   INTRAVENOU</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>THERAPEUTIC PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041219</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534227-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004231869US</companynumb>
    <primarysource>
      <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 FOLATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL SOFT TISSUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROGOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCOLAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534228-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93.441</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10MG   DAILY   ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534229-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004231878US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN WITH ANTIOXIDANTS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534230-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93.441</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534231-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004231903US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugbatchnumb>87KWT</drugbatchnumb>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIINFLAMMATORY THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534233-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004231928US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIP ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG BID ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534235-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040875806</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534236-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041221</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>250 MG IV 2-3 DOSES/CYCLE X 5 CYCLES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLEOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534237-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004231943US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TONGUE BLISTERING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534238-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040526</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-BRISTOL-MYERS SQUIBB COMPANY-12596318</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPODYSTROPHY ACQUIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040103</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534239-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004232015US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINEA PEDIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN/PSEUDOP. HCL/COD. PHOS. ^SCHEIN^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534240-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12797585</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>LOADING DOSE, 400 PER METER SQUARED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041202</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041104</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAMPTOSAR</medicinalproduct>
        <drugdosagetext>180/M2 (300 MG)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041130</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534241-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12798435</companynumb>
    <primarysource>
      <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>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534242-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12798229</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534243-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040875807</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>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534244-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004232163US</companynumb>
    <primarysource>
      <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>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPICONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISTARIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534245-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-BRISTOL-MYERS SQUIBB COMPANY-12797056</companynumb>
    <primarysource>
      <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>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEVALOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534246-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12796603</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>109</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugbatchnumb>0300497B</drugbatchnumb>
        <drugdosagetext>1ST INFUSION, 812 MG ORDERED, 500 MG RECEIVED BEFORE EVENT ONSET, ^ON HOLD^</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugbatchnumb>0300497B</drugbatchnumb>
        <drugdosagetext>1ST INFUSION, 812 MG ORDERED, 500 MG RECEIVED BEFORE EVENT ONSET, ^ON HOLD^</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO LIVER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041206</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAIN MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534247-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200414703FR</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534248-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200419679US</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROFECOXIB</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICONAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTYRAMINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040831</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534249-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040130</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200410226JP</companynumb>
    <primarysource>
      <qualification>3</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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL MYELOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</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>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>DOSE: 2T</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECOBALAMINE</medicinalproduct>
        <drugindication>CERVICAL MYELOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECOBALAMINE</medicinalproduct>
        <drugindication>VITAMIN B12 DEFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHIECTASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCTIVE COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISPHOSPHONATES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROMIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040106</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534250-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040426</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200413228US</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.63</patientweight>
      <patientsex>1</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 ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</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>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ST. JOHN'S WORT</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>DOSE: NOT PROVIDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL PM</medicinalproduct>
        <drugdosagetext>DOSE: 2 TABLETS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534251-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040409</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200412793US</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </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>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPLEURAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPYEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED SELF-CARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHONCHI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERIDEX</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>ATROVENT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYADEC</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAPACE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORUVAIL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HCL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534252-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>200417995US</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CUTANEOUS LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SSRI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534254-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040827</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004232250US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534257-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040827</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004232252US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG QD ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534258-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041101</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-12751988</companynumb>
    <primarysource>
      <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>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040726</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEPESID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040728</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugdosagetext>66 GY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040909</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534259-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-12798161</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOPHOS</medicinalproduct>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534261-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040875858</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugbatchnumb>73H06A</drugbatchnumb>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE (RAMIPRIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN (ATENOLOL EG)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX MR (TAMSULOSIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAYPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN (ACDTYLSALICYLIC ACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534262-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004232409US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE + D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS (PANTHENOL, RETINOL, ERGOCALCIFEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534265-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004231376US</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugindication>MUSCLE STRAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534266-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-12771911</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534267-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004231387US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534268-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>USA040875881</companynumb>
    <primarysource></primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>21368</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX MR (TAMSULOSIN HYDROCHLORIDE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534269-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004231406US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534270-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004231408US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CRAMP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534271-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004231414US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534272-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004231419US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534274-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004231423US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFICULTY IN WALKING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534275-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004231426US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>30 MC, QD</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN ES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534277-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041222</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20030724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHBS2003JP07813</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL RETARDATION SEVERITY UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEFENAMIC ACID</medicinalproduct>
        <drugdosagetext>2 ML, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>12.5 MG/DAY</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534278-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004231552US</companynumb>
    <primarysource>
      <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>TYPE III IMMUNE COMPLEX MEDIATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugauthorizationnumb>21341</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TENDONITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>4534279-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20050328</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20041214</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2004231559US</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <rea